The Effects of Biocompatible Compared with Standard Peritoneal Dialysis Solutions on Peritonitis Microbiology, Treatment, and Outcomes: TheBalanz Trial

BackgroundA multicenter, multi-country randomized controlled trial (the balANZ study) recently reported that peritonitis rates significantly improved with the use of neutral-pH peritoneal dialysis (PD) solutions low in glucose degradation products (“biocompatible”) compared with standard solutions. The present paper reports a secondary outcome analysis of the balANZ trial with respect to peritonitis microbiology, treatment, and outcomes.MethodsAdult incident PD patients with residual renal function were randomized to receive either biocompatible or conventional (control) PD solutions for 2 years.ResultsThe safety population analysis for peritonitis included 91 patients in each group. The unadjusted geometric mean peritonitis rates in those groups were 0.30 [95% confidence interval (CI): 0.22 to 0.41] episodes per patient–year for the biocompatible group and 0.49 (95% CI: 0.39 to 0.62) episodes per patient–year for the control group [incidence rate ratio (IRR): 0.61; 95% CI: 0.41 to 0.90; p = 0.01]. When specific causative organisms were examined, the rates of culture-negative, gram-positive, gram-negative, and polymicrobial peritonitis episodes were not significantly different between the biocompatible and control groups, although the biocompatible group did experience a significantly lower rate of non-pseudomonal gram-negative peritonitis (IRR: 0.41; 95% CI: 0.18 to 0.92; p = 0.03). Initial empiric antibiotic regimens were comparable between the groups. Biocompatible fluid use did not significantly reduce the risk of peritonitis-associated hospitalization (adjusted odds ratio: 0.80; 95% CI: 0.48 to 1.34), but did result in a shorter median duration of peritonitis-associated hospitalization (6 days vs 11 days, p = 0.05). Peritonitis severity was more likely to be rated as mild in the biocompatible group (37% vs 10%, p = 0.001). Overall peritonitis-associated technique failures and peritonitis-related deaths were comparable in the two groups.ConclusionsBiocompatible PD fluid use was associated with a broad reduction in gram-positive, gram-negative, and culture-negative peritonitis that reached statistical significance for non-pseudomonal gram-negative organisms. Peritonitis hospitalization duration was shorter, and peritonitis severity was more commonly rated as mild in patients receiving biocompatible PD fluids, although other peritonitis outcomes were comparable between the groups.

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Anti-PF4/Heparin Antibody Levels in Bacteremia, Fungemia and Sepsis

Blood ◽

10.1182/blood-2018-99-117917 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 3752-3752

Author(s):

Satish Maharaj ◽

Simone Chang ◽

Karan Seegobin ◽

Fauzia Rana ◽

Marwan Shaikh

Keyword(s):

Immune Response ◽

Statistical Significance ◽

Small Sample ◽

Primary Immune Response ◽

Control Group ◽

Gram Positive ◽

Platelet Factor ◽

Gram Negative ◽

Significant Difference ◽

Antibody Levels

Abstract Heparin-induced thrombocytopenia (HIT) is caused by antibodies targeting platelet factor 4 (PF4)/heparin complexes. The immune response leading to HIT remains perplexing with many paradoxes. Unlike other drug induced reactions, anti-PF4/heparin antibody generation does not follow the classic immunologic response. As Greinacher and colleagues have shown, the primary immune response lacks IgM precedence and class switching, and heparin-induced antibodies can induce HIT by day 5 in heparin-naïve patients.Continued exposure to heparin also is puzzling with a weak or declining secondary immune response. Research by Krauel and colleagues suggests that that there is close interplay among infection, PF4 and the immune system. In 2010 they demonstrated that human and murine PF4 bind to Gram positive (S.aureus, S.pneumoniae, L.monocytogenes) and Gram negative (E.coli, N.meningitidis) bacteria in vitro, with bacterial surfaces acting as polyanions. High dose heparin inhibited this binding and anti-PF4/heparin antibodies from patients with HIT reacted with these PF4/bacterial complexes (S. aureus and E. coli). Using a murine model, they went on to show that polymicrobial sepsis in the absence of heparin led to antibody generation. In a separate study, Krauel and colleagues also showed that PF4 binds specifically to the lipid A component of Gram negative bacteria. In this analysis, we report on anti-PF4/heparin antibody levels in groups of patients hospitalized for sepsis, as compared to a control group without sepsis. We examined 200 patients with sepsis, retrospectively identified, from a hospital database of anti-PF4/heparin testing done in medical inpatients with thrombocytopenia but low pretest probability of HIT. This included patients with bacteremia (57), fungemia (7) and sepsis without septicemia (136). For comparison, data from 50 patients without sepsis during the same time period was used. Inclusion criteria for all groups were age 18 years and older and antibody testing within 4 days of admission. Exclusion criteria were diagnosis of HIT or heparin allergy, prior hospitalization or heparin exposure within 90 days of admission, cardiopulmonary bypass or orthopedic surgery within 6 months, hemodialysis, active or past malignancy, antiphospholipid syndrome, autoimmune disease or immunosuppressive therapy. All patients studied were on subcutaneous heparin at prophylactic doses only (i.e. no intravenous use, no therapeutic anticoagulation). UFH use predominated with prevalence of >85% in all groups. Testing was done using a commercially available standardized solid phase enzyme-linked immunoassay (EIA) to detect antibodies (IgG/IgA/IgM) directed against PF4 complexed with polyvinylsulfonate (Genetic Testing Institute, Wisconsin). All assays were performed in the central hospital laboratory according to manufacturer's specifications and measured in optical density (OD) units. The data sets demonstrated continuous unimodal distribution with high OD outliers, indicative of varying immune responses along a continuum. Statistical significance was calculated using independent t-testing with p-value set at 0.05 for significance. Results showed that patients hospitalized with sepsis have higher anti-PF4/heparin antibody levels. Both patients with bacteremia, and sepsis without bacteremia, had significantly higher OD than patients without sepsis (p<0.05). There was no significant difference between Gram negative and Gram positive bacteremia and antibody levels. This suggests that bacterial cell wall components of both classes have similar antigenicity. Interestingly, patients with fungemia had much lower antibody levels compared to bacteremia and sepsis. Despite the small sample size for fungemia, this difference trended strongly towards statistical significance (p=0.05). The threshold for a positive EIA is currently established at OD>0.400, a value based on sensitivity and set by the manufacturer. When the prevalence of a positive EIA was assessed, 16% patients with sepsis and bacteremia tested positive compared to 4% in the control group. In summary, there is an increased prevalence of anti-PF4/heparin antibodies in patients hospitalized with bacterial but not fungal sepsis. These results support the theory that bacterial infection has a role to play in preimmunization leading to anti-PF4/heparin antibody generation. Disclosures No relevant conflicts of interest to declare.

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Outcome of Gram-Positive and Gram-Negative Peritonitis in Patients on Continuous Ambulatory Peritoneal Dialysis: A Single-Center Experience

Peritoneal Dialysis International ◽

10.1177/089686080302302s30 ◽

2003 ◽

Vol 23 (2_suppl) ◽

pp. 144-147 ◽

Cited By ~ 24

Author(s):

Narayan Prasad ◽

Amit Gupta ◽

Raj K. Sharma ◽

Kashi N. Prasad ◽

Sanjeev Gulati ◽

...

Keyword(s):

Peritoneal Dialysis ◽

Continuous Ambulatory Peritoneal Dialysis ◽

Total Duration ◽

Educational Status ◽

Developed Countries ◽

Outcome Analysis ◽

Gram Positive ◽

Fungal Peritonitis ◽

Gram Negative ◽

Single Center Experience

Background The spectrum of bacterial peritonitis in patients on continuous ambulatory peritoneal dialysis (CAPD) in India may be different from that seen in developed countries because of differences in culture and in social, environmental, financial, and educational status. We analyzed our data regarding the incidence and outcome of monomicrobial peritonitis in our CAPD patients. Patients and Methods We reviewed the records of 225 patients on CAPD to retrieve data concerning demographics, peritonitis rate, organism isolated, and outcome. Polymicrobial and fungal peritonitis were excluded from the outcome analysis because of their different outcomes. Results We identified 168 episodes of peritonitis (range: 1 – 6 episodes per patient). Of the 168 episodes, 106 (63.1%) episodes were culture-positive. Total duration of CAPD was 264.16 patient–years. The overall peritonitis rate was 0.63 episodes per patient–CAPD year. The rates of gram-negative, gram-positive, polymicrobial, and fungal peritonitis were 0.17, 0.11, 0.04, 0.09 episodes per patient–year, respectively. Among the 75 episodes of monomicrobial peritonitis, gram-negative episodes [ n = 45 (60%)] were significantly more frequent than gram-positive episodes [ n = 30 (40%), p = 0.03]. Escherichia coli was the most commonly seen organism. Organisms of fecal origin (40/75) were significantly more frequent than those of skin origin (21/75, p = 0.0016). Catheter loss (17/45 vs 5/20, p = 0.04), hospitalization (31/ 45 vs 13/30, p = 0.03), death [9/45 vs 3/30, p = nonsignificant (NS)], switch to hemodialysis (8.9% vs 3.3%, p = NS), and reimplantation of the catheter (6.6% vs 3.3%, p = NS) were all more frequent in gram-negative episodes than in gram-positive episodes. Conclusions Gram-negative peritonitis is more frequent than gram-positive peritonitis in our CAPD population in India and is associated with worse outcome.

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Maternal and Infant Supplementation with Small-Quantity Lipid-Based Nutrient Supplements Increases Infants’ Iron Status at 18 Months of Age in a Semiurban Setting in Ghana: A Secondary Outcome Analysis of the iLiNS-DYAD Randomized Controlled Trial

Journal of Nutrition ◽

10.1093/jn/nxy225 ◽

2019 ◽

Vol 149 (1) ◽

pp. 149-158 ◽

Cited By ~ 5

Author(s):

Seth Adu-Afarwuah ◽

Rebecca T Young ◽

Anna Lartey ◽

Harriet Okronipa ◽

Per Ashorn ◽

...

Keyword(s):

Folic Acid ◽

Low Income ◽

Iron Status ◽

Controlled Trial ◽

Geometric Mean ◽

Secondary Outcome ◽

Outcome Analysis ◽

Zinc Protoporphyrin ◽

Lower Prevalence ◽

Nutrient Supplements

ABSTRACT Background Interventions are needed to address iron deficiency in low-income settings. Objective This secondary outcome analysis aimed to compare the hemoglobin (Hb) and iron status [zinc protoporphyrin (ZPP)] of children born to women enrolled in the iLiNS-DYAD trial in Ghana. Methods Women ≤20 wk pregnant (n = 1320) were assigned to receive 60 mg Fe/d and 400 µg folic acid/d until delivery and placebo thereafter, and no supplementation for infants (IFA group); or multiple micronutrients containing 20 mg Fe/d until 6 mo postpartum and no supplementation for infants (MMN); or small-quantity lipid-based nutrient supplements (SQ-LNSs) containing 20 mg Fe/d until 6 mo postpartum, and SQ-LNSs for infants from 6 to 18 mo of age (LNS). We compared infants’ Hb (g/L) and ZPP (µmol/mol heme) at 6 and 18 mo of age. Results At 6 mo of age, groups did not differ in mean ± SD Hb (overall: 113 ± 9.9 g/L) or geometric mean (95% CI) ZPP [overall: 62.6 (60.6, 64.7)]. At 18 mo of age, mean ± SD Hb (overall: 112 ± 10.4 g/L) did not differ significantly between groups, whereas geometric mean (95% CI) ZPP was lower (P = 0.031) in the LNS group [53.9 (50.7, 57.3)] than the IFA [60.4 (56.7, 64.3)] but not the MMN [58.8 (55.6, 62.2)] group. Further, the LNS group, compared with the IFA and MMN groups combined, had a lower prevalence of elevated (>70) ZPP (27.5% compared with 35%; P = 0.02) and a marginally lower prevalence of anemia (38.7% compared with 44.9%; P = 0.06). These results generally remained unchanged when controlling for prespecified covariates or correcting for inflammation. Conclusions In this setting, providing SQ-LNSs or multiple micronutrients with 20 mg Fe/d, compared with iron (60 mg/d) and folic acid, to pregnant women does not affect their infants’ Hb or iron status at 6 mo of age, but maternal and infant supplementation with SQ-LNSs increases infants’ iron status at 18 mo of age. This trial was registered at clinicaltrials.gov as NCT00970866.

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Retrospective single-center analysis of the reasons and serious complications of peritoneal-related peritonitis in patients with end-stage renal disease undergoing peritoneal dialysis treatment

Polish Journal of Public Health ◽

10.2478/pjph-2018-0019 ◽

2018 ◽

Vol 128 (3) ◽

pp. 103-106

Author(s):

Agnieszka M. Grzebalska ◽

Anna Steć ◽

Izabela Ławnicka ◽

Anna Bednarek-Skublewska ◽

Andrzej Książek

Keyword(s):

Peritoneal Dialysis ◽

Medical Center ◽

Gram Positive ◽

Dialysis Treatment ◽

Gram Negative ◽

Antibiotics Use ◽

Stage Renal Disease ◽

End Stage ◽

Culture Negative ◽

Dialysis Discontinuation

Abstract Introduction. Peritonitis is still a serious complication of peritoneal dialysis (PD). Consequences of peritonitis can be severe. The most severe are peritoneal dialysis discontinuation and patient’s death. In majority, peritonitis is bacterial in the origin. Mainly there is a gram-positive infection, less commonly gram-negative one. Some peritonitis are culture-negative, because of former antibiotics use. In minority, fungal, tuberculous or even viral peritonitis are observed. Aim. The aim of the present study is to analyze the number, origin and serious complications of peritoneal-related peritonitis cases found in our PD center. Material and methods. We performed a retrospective five-years evaluation of medical records. The total number of peritonitis episodes was 56 cases, underwent by 30 adult patients on chronic peritoneal dialysis. Peritonitis was diagnosed according to ISPD recommendations. Causes and serious complications of peritoneal-related peritonitis were analyzed in every single year. Etiology of peritonitis was classified on the basis of the result of effluent dialysate culture as: gram-positive, gram-negative and culture negative. Peritoneal dialysis discontinuation or patient’s death were defined as serious complications. Results. Among 56 cases of peritoneal-related peritonitis 44.6% were gram-positive, 26.8% gram-negative and 28.6% culture-negative. No fungal or tuberculosis peritonitis were found. Because of the peritonitis complications in the evaluated period, six patients discontinued peritoneal dialysis and were switched to hemodialysis (20%), two others died (6.7%). Conclusion. The further improvement in peritonitis’ causes identification and treatment is needed in order to reduce number of serious complications in our medical center.

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Effect of Nut Consumption on Erectile and Sexual Function in Healthy Males: A Secondary Outcome Analysis of the FERTINUTS Randomized Controlled Trial

Nutrients ◽

10.3390/nu11061372 ◽

2019 ◽

Vol 11 (6) ◽

pp. 1372 ◽

Cited By ~ 2

Author(s):

Albert Salas-Huetos ◽

Jananee Muralidharan ◽

Serena Galiè ◽

Jordi Salas-Salvadó ◽

Mònica Bulló

Keyword(s):

Sexual Function ◽

Sexual Desire ◽

Erectile Function ◽

Controlled Trial ◽

Secondary Outcome ◽

Outcome Analysis ◽

Control Group ◽

P Value ◽

Excessive Alcohol Consumption ◽

Randomized Controlled

Lifestyle risk factors for erectile and sexual function include smoking, excessive alcohol consumption, lack of physical activity, psychological stress, and adherence to unhealthy diets. In the present study, we evaluated the effects of mixed nuts supplementation on erectile and sexual function. Eighty-three healthy male aged 18–35 with erectile function assessment were included in this FERTINUTS study sub-analysis; a 14-week randomized, controlled, parallel feeding trial. Participants were allocated to (1) the usual Western-style diet enriched with 60 g/day of a mixture of nuts (nut group; n = 43), or (2) the usual Western-style diet avoiding nuts (control group; n = 40). At baseline and the end of the intervention, participants answered 15 questions contained in the validated International Index of Erectile Function (IIEF), and peripheral levels of nitric oxide (NO) and E-selectin were measured, as surrogated markers of erectile endothelial function. Anthropometrical characteristics, and seminogram and blood biochemical parameters did not differ between intervention groups at baseline. Compared to the control group, a significant increase in the orgasmic function (p-value = 0.037) and sexual desire (p-value = 0.040) was observed during the nut intervention. No significant differences in changes between groups were shown in peripheral concentrations of NO and E-selectin. Including nuts in a regular diet significantly improved auto-reported orgasmic function and sexual desire.

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Does regular strength training cause urinary incontinence in overweight inactive women? A randomized controlled trial

International Urogynecology Journal ◽

10.1007/s00192-021-04739-5 ◽

2021 ◽

Author(s):

Kari Bø ◽

Lene Anette H. Haakstad ◽

Gøran Paulsen ◽

Anne Mette Rustaden

Keyword(s):

Randomized Controlled Trial ◽

Urinary Incontinence ◽

Strength Training ◽

Short Form ◽

Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Randomized Controlled ◽

Sum Score ◽

New Onset

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.

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The epidemiology of central venous catheter-related bloodstream infection in our renal units is changing

The Journal of Vascular Access ◽

10.1177/1129729821990222 ◽

2021 ◽

pp. 112972982199022

Author(s):

Salvatore Mandolfo ◽

Adriano Anesi ◽

Vanina Rognoni

Keyword(s):

Burkholderia Cepacia ◽

Present Report ◽

Statistical Significance ◽

Bloodstream Infections ◽

Venous Catheter ◽

Renal Unit ◽

Gram Positive ◽

Gram Negative ◽

Gram Positive Bacteria ◽

Over Time

Recent reports have shown an increase in the rate of Gram-negative bacteremia in several settings, including catheter-related bloodstream infections (CRBSI). To analyze if the epidemiology of CRBSI is also changing in hemodialysis patients, we revisited the etiology of CRBSIs in our renal unit over 8 years. During the observed periods, 149 episodes of CRBSIs were reported and the CRBSI incidence rate, ranged between 0.67 and 0.82 episodes/1000 tCVC days. Of these 149 episodes, 84 (56.3%) were due to Gram-positive bacteria, 62 (41.6%) to Gram-negative bacteria, and 3 (2.1%) to polymicrobial flora, no episodes of fungi were found. There was a trend, but not statistically significative, increase over time in the number of Gram-negative CRBSIs among the total CRBSIs, rising from 37.8% in the first period to 41.2% in the second period and to 44.3% in the last period, with a parallel decrease in the percentage of Gram-positive CRBSIs (from 59.5% to 56.9% and subsequently to 54.1%). Between Gram-negative, we reported an intensification of CRBSI due to Enterobacterales, particularly Escherichia coli. Among the Gram-negative, we have isolated germs rarely reported in the literature, such as Burkholderia cepacia, Pantoea agglomerans, and Rhizobium radiobacter. Regarding Gram-positive bacteria, a triplicate incidence of Staphylococcus aureus was reported with MRSA accounting for 42% in the third period. Among the Gram-positive bacteria, we reported two episodes of Kocuria kristinae and two of Bacillus spp. Our data demonstrated that the epidemiology of CRBSI in the same center, will change over time and Gram-negative strains are an increasing cause of CRBSI. The limitation of the present report is that statistical significance has not been reached, probably due to the limited number of CRBSI. New bacteria, both Gram-negative and Gram-positive, are emerging. Collaboration with the Microbiology Department appears essential to an appropriate diagnosis.

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Fascial treatment versus manual therapy (HVLA) in patients with chronic neck pain: A randomized controlled trial

Journal of Back and Musculoskeletal Rehabilitation ◽

10.3233/bmr-191731 ◽

2021 ◽

pp. 1-10

Author(s):

Katrin Brück ◽

Kirsten Jacobi ◽

Tobias Schmidt

Keyword(s):

Neck Pain ◽

Manual Therapy ◽

Repeated Measures ◽

Primary Outcome ◽

Controlled Trial ◽

Severity Of Illness ◽

Chronic Neck Pain ◽

Secondary Outcome ◽

Control Group ◽

Industrialized Nations

BACKGROUND: Chronic neck pain (CNP) is a common health problem in western industrialized nations. In recent years, the fascial tissue has attracted the attention of therapists, and a treatment of the fasciae promises to be a meaningful approach in the therapy of patients with CNP. OBJECTIVE: The aim of this study was to investigate the effectiveness of a fascial treatment (FT) compared to manual therapy (MT) and to no intervention (control group, CG) in patients with CNP. METHODS: Sixty participants with CNP were randomized into three groups. Primary outcome parameters were pain intensity as measured by the visual analogue scale (VAS), and severity of illness as measured by the Neck Pain and Disability Scale (NPAD). Secondary outcome parameter was the range of motion (ROM) of the cervical spine. RESULTS: Repeated measures t-tests demonstrated significant decreases with medium to large effect sizes for the FT (VAS: dR⁢M= 1.14; NPAD: dR⁢M= 0.51) and for the MT (VAS: dR⁢M= 1.15; NPAD: dR⁢M= 0.72). CONCLUSION: Our results confirmed the effectiveness of MT on pain and severity of illness in the treatment of patients suffering from CNP. Furthermore, the results demonstrated the effectiveness and clinical relevance of FT for this population.

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Rationale and design for Lowering-hyperUricaemia treatment on cardiovascular outcoMes In peritoNeal diAlysis patients: a prospective, multicentre, double-blind, randomised controlled trial (LUMINA)

BMJ Open ◽

10.1136/bmjopen-2020-037842 ◽

2020 ◽

Vol 10 (10) ◽

pp. e037842

Author(s):

Wei Chen ◽

Naya Huang ◽

Haiping Mao ◽

Xiao Yang ◽

Qian Zhou ◽

...

Keyword(s):

Peritoneal Dialysis ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Dropout Rate ◽

Cardiovascular Outcomes ◽

Control Group ◽

Type I ◽

Dialysis Patients ◽

Double Blind ◽

Randomised Controlled

IntroductionThe prevalence of hyperuricaemia in peritoneal dialysis patients is quite high. Studies have demonstrated a correlation between hyperuricaemia and cardiovascular disease and treatment of hyperuricaemia reportedly reduces cardiovascular risk in patients with chronic kidney disease. However, whether hyperuricaemia treatment benefits cardiovascular outcomes in continuous ambulatory peritoneal dialysis (CAPD) patients is not yet known.Methods and analysesThis prospective, multicentre, double-blind, randomised controlled trial was designed to evaluate the effects of hyperuricaemia treatment on cardiovascular event risk in CAPD patients. Based on a power of 80%, with type I error α=0.05, two-sided test and 1:1 parallel control study, considering a dropout rate of 20%, a total of 548 eligible patients are expected to be randomly assigned to either the hyperuricaemia treatment group (febuxostat) or control group (placebo).Ethics and disseminationThis study has been approved by the Medical Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University and the ethics committees of other participating institutions. Written informed consent will be obtained from potential trial participants or authorised surrogates.The findings of the study will be disseminated through publications in peer-reviewed journals, and presentations at national and international conferences.Trial registration numberNCT03200210. 25 June 2017. The trial was started on 13 July 2017, and is expected to end by 31 December 2022. Till 20 Jan 2020, a total of 548 patients have been recruited.Protocol versionThe protocol version number and date are YLT-1604-V2.0 and 15 December 2016.

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Impact of ascorbic acid in reducing the incidence of vancomycin associated nephrotoxicity in critically ill patients: A preliminary randomized controlled trial

F1000Research ◽

10.12688/f1000research.55619.1 ◽

2021 ◽

Vol 10 ◽

pp. 929

Author(s):

Nouran Hesham El-Sherazy ◽

Naglaa Samir Bazan ◽

Sara Mahmoud Shaheen ◽

Nagwa A. Sabri

Keyword(s):

Ascorbic Acid ◽

Critically Ill ◽

Critically Ill Patients ◽

Statistical Significance ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Control Groups ◽

The Absolute ◽

And Control

Background Antioxidants show nephroprotective effect against vancomycin associated nephrotoxicity (VAN) in animals. This study aimed to assess the ascorbic acid nephro-protective role against VAN clinically. Methods Forty-one critically ill patients were randomly assigned to one of two groups: intervention group (vancomycin IV plus ascorbic acid, n=21) or control group (vancomycin IV only, n=20). Primary outcomes were the incidence of VAN and the absolute change in creatinine parameters, while mortality rate was the secondary outcome. Nephrotoxicity was defined as an increase in serum creatinine (S.cr) by at least 0.5 mg/dL or 50% of baseline for at least two successive measurements. This study is registered at Clinicaltrials.gov (NCT03921099), April 2019. Results Mean absolute S.cr increase was significant when compared between both groups, P-value = 0.036, where S.cr increased by 0.05(0.12) and 0.34(0.55) mg/dL in the intervention and control groups, respectively. Mean absolute Cr.cl decline was significant when compared between both groups, P-value = 0.04, where Cr.cl was decreased by 5.9(17.8) and 22.3(30.4) ml/min in the intervention and control groups, respectively. Incidence of VAN was 1/21(4.7%) versus 5/20(25%) in the intervention and control groups, respectively (RR: 0.19; CI: 0.024–1.49; P-value = 0.093). Mortality was higher in the control group; however, it was not statistically significant, P-value = 0.141. Conclusion Co-administration of ascorbic acid with vancomycin preserved renal function and reduced the absolute risk of VAN by 20.3%, however, the reduction in VAN incidence didn’t reach statistical significance level. Further large multicenter prospective trials are recommended.

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