Erythropoietin in Acute Kidney Injury (EAKI): a Pragmatic Randomized Clinical Trial

Abstract Background Treatment with erythropoietin is well established for anemia in chronic kidney disease patients but not well studied in acute kidney injury.MethodsThis is a multicenter, randomized, pragmatic controlled clinical trial. It included 134 hospitalized patients with anemia defined as hemoglobin <11 g/dL and acute kidney injury defined as an increase of serum creatinine of 0.3 mg/dL within 48 hours or 1.5 times baseline. One arm received recombinant human erythropoietin 4000 UI subcutaneously every other day (intervention; n=67) and the second received standard of care (control; n=67) during the hospitalization until discharge or death. The primary outcome was the need for transfusion; secondary outcomes were death, renal recovery, need for dialysis.ResultsThere was no statistically significant difference in transfusion need (RR=1.05, 95%CI 0.65,1.68; p=0.855), in renal recovery full or partial (RR=0.96, 95%CI 0.81,1.15; p=0.671), in need for dialysis (RR=11.00, 95%CI 0.62, 195.08; p=0.102) or in death (RR=1.43, 95%CI 0.58,3.53; p=0.440) between the erythropoietin and the control group. ConclusionsErythropoietin treatment had no impact on transfusions, renal recovery or mortality in acute kidney injury patients with anemia. The trial was registered on ClinicalTrials.gov (NCT03401710, 17/01/2018).

Download Full-text

A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial of High-Dose, Short-Term Vitamin D Administration in the Prevention of Acute Kidney Injury after Cardiac Surgery

Cardiorenal Medicine ◽

10.1159/000511058 ◽

2021 ◽

pp. 1-7

Author(s):

Pegah Eslami ◽

Manouchehr Hekmat ◽

Mahmoud Beheshti ◽

Ramin Baghaei ◽

Seyed Mohsen Mirhosseini ◽

...

Keyword(s):

Clinical Trial ◽

Vitamin D ◽

Acute Kidney Injury ◽

Cardiac Surgery ◽

Kidney Injury ◽

Control Group ◽

Controlled Clinical Trial ◽

High Dose ◽

Double Blind ◽

Postoperative Aki

Background: Acute kidney injury (AKI) after cardiac surgery is a relatively common complication affecting short- and long-term survival. The renoprotective effect of vitamin D (VitD) has been confirmed in several experimental models. This study was conducted to evaluate the effect of high-dose VitD administration in patients with VitD insufficiency on the incidence of postoperative AKI, the urinary level of tubular biomarkers, and serum anti-inflammatory biomarker after coronary artery bypass graft. Design and Method: In this randomized double-blind controlled clinical trial, the patients were randomly allocated to either the VitD group (n = 50), receiving 150,000 IU VitD tablets daily for 3 consecutive days before surgery or the control group (n = 61), receiving placebo tablets. Results: There was no difference in the incidence of postoperative AKI between the groups. Both of the urinary levels of interleukin-18 and kidney injury molecule-1 were significantly increased after the operation (p < 0.001, for both). Also, the serum level of interleukin-10 was increased after 3 days of VitD supplementation (p = 0.001). In comparison with the control group, it remained on a higher level after the operation (p < 0.001) and the next day (p = 0.03). The patients with AKI had more postoperative bleeding and received more blood transfusion. Conclusion: VitD pretreatment was unable to impose any changes in the incidence of AKI and the urinary level of renal biomarkers. However, high-dose administration of VitD may improve the anti-inflammatory state before and after the operation. Further studies are needed to assess the renoprotective effect of VitD on coronary surgery patients.

Download Full-text

The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

BMC Endocrine Disorders ◽

10.1186/s12902-021-00731-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Zahra Barati ◽

Mina Iravani ◽

Majid Karandish ◽

Mohammad Hosein Haghighizadeh ◽

Sara Masihi

Keyword(s):

Clinical Trial ◽

Blood Glucose ◽

Gestational Diabetes ◽

Fasting Blood Glucose ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Standard Diet ◽

Oat Bran ◽

Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

Download Full-text

A randomized controlled clinical trial of the effect of supportive counseling on mental health in Iranian mothers of premature infants

BMC Pregnancy and Childbirth ◽

10.1186/s12884-020-03502-w ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Leila Seiiedi-Biarag ◽

Mojgan Mirghafourvand ◽

Khalil Esmaeilpour ◽

Shirin Hasanpour

Keyword(s):

Mental Health ◽

Clinical Trial ◽

Premature Infants ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled ◽

Significant Difference ◽

Postpartum Bonding ◽

Supportive Counseling

Abstract Background Premature birth can affect maternal mental health. Considering that the mental health disorder in mothers may play a vital role in the growth and development of their children, therefore, this study was conducted to determine the effect of supportive counseling on mental health (primary outcome), mother-child bonding and infant anthropometric indices (secondary outcomes) in mothers of premature infants. Methods This randomized controlled clinical trial was carried out on 66 mothers with hospitalized neonates in the NICU of Alzahra hospital in Tabriz- Iran. Participants were randomly allocated into two groups of intervention (n = 34) and control (n = 32) through a block randomization method. The intervention group received 6 sessions of supportive counseling (45–60 minutes each session) by the researcher, and the control group received routine care. Questionnaires of Goldberg General Health and the postpartum bonding were completed before the intervention (first 72 hours postpartum) and 8 weeks postpartum. Also, the anthropometric index of newborns were measured at the same time. Results There was no statistically significant difference between the two groups in terms of socio-demographic characteristics. After the intervention, based on ANCOVA with adjusting the baseline score, mean score of mental health (AMD: -9.8; 95% Confident Interval (95% CI): -12.5 to -7.1; P < 0.001) and postpartum bonding (AMD: -10.0; 95% CI: -0.6 to 13.9; P < 0.001) in the counseling group was significantly lower than those of the control group; however, in terms of weight (P = 0.536), height (P = 0.429) and head circumference (P = 0.129), there was no significant difference between the two groups. Conclusions Supportive counseling may improve mental health and postpartum bonding in mothers of premature infants. Thus, it may be recommendable for health care providers to offer it to mothers. Trial registration Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N45. Date of registration: October 29, 2018.

Download Full-text

Effectiveness of a home care teaching program for prostatectomized patients: a randomized controlled clinical trial

Revista da Escola de Enfermagem da USP ◽

10.1590/s1980-220x2018012503421 ◽

2019 ◽

Vol 53 ◽

Author(s):

Luciana Regina Ferreira da Mata ◽

Cissa Azevedo ◽

Mariana Ferreira Vaz Gontijo Bernardes ◽

Tânia Couto Machado Chianca ◽

Maria da Graça Pereira ◽

...

Keyword(s):

Clinical Trial ◽

Home Care ◽

Self Efficacy ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Teaching Program ◽

Significant Difference ◽

The Times

ABSTRACT Objective: To evaluate the effectiveness of a teaching program for hospital discharge of patients submitted to radical prostatectomy based on the self-efficacy construct of the Cognitive Social Theory. Method: A controlled clinical trial carried out on a 2-month follow-up of 68 prostatectomized men randomized into intervention group (n = 34) and control (n = 34). The intervention group received routine guidance from the service plus the teaching program. The control group only received routine guidance from the service. The data collection instruments were: sociodemographic and clinical questionnaire, self-efficacy scale, hospital depression and anxiety scale, household care knowledge questionnaire, and an item on satisfaction with a score of 1 to 5. Results: There was a significant difference between the intragroups for satisfaction (p<0.001) and knowledge (p<0.001) of the pre-test to the post-test. In the intervention group, there were significant changes between the times for anxiety (p=0.011) and knowledge (p<0.001). Conclusion: The teaching program with a combination of oral guidance, written instruction and telephone follow-up was effective in improving knowledge about home care and personal satisfaction. Brazilian Registry of Clinical Trials: RBR-5n95rm.

Download Full-text

Postoperative Acute Kidney Injury: Focus on Renal Recovery Definitions, Kidney Disease Progression and Survival

American Journal of Nephrology ◽

10.1159/000496611 ◽

2019 ◽

Vol 49 (3) ◽

pp. 175-185 ◽

Cited By ~ 3

Author(s):

Thorir E. Long ◽

Solveig Helgadottir ◽

Dadi Helgason ◽

Gisli H. Sigurdsson ◽

Tomas Gudbjartsson ◽

...

Keyword(s):

Acute Kidney Injury ◽

Kidney Disease ◽

Propensity Score ◽

Matched Control ◽

Kidney Injury ◽

Renal Recovery ◽

University Hospital ◽

Control Group ◽

One Year ◽

Definition Of

Background: The aim of this study was to examine different definitions of renal recovery following postoperative acute kidney injury (AKI) and how these definitions associate with survival and the development and progression of chronic kidney disease (CKD). Methods: This was a retrospective study of all patients who underwent abdominal, cardiothoracic, vascular, or orthopedic surgery at a single university hospital between 1998 and 2015. Recovery of renal function following postoperative AKI was assessed comparing 4 different definitions: serum creatinine (SCr) (i) < 1.1 × baseline, (ii) 1.1–1.25 × baseline, (iii) 1.25–1.5 × baseline, and (iv) > 1.5 × baseline. One-year survival and the development or progression of CKD within 5 years was compared with a propensity score-matched control groups. Results: In total, 2,520 AKI patients were evaluated for renal recovery. Risk of incident and progressive CKD within 5 years was significantly increased if patients did not achieve a reduction in SCr to < 1.5 × baseline (hazard ratio [HR] 1.50; 95% CI 1.29–1.75) and if renal recovery was limited to a fall in SCr to 1.25–1.5 × baseline (HR 1.32; 95% CI 1.12–1.57) within 30 days. The definition of renal recovery that best predicted survival was a reduction in SCr to < 1.5 × baseline within 30 days. One-year survival of patients whose SCr decreased to < 1.5 × baseline within 30 days was significantly better than that of a propensity score-matched control group that did not achieve renal recovery (85 vs. 71%, p < 0.001). Conclusions: These findings should be considered when a consensus definition of renal recovery after AKI is established.

Download Full-text

The effect of delivery ball and warm shower on the childbirth experience of nulliparous women: A randomized controlled clinical trial

10.21203/rs.3.rs-903099/v1 ◽

2021 ◽

Author(s):

parvaneh sharifipour ◽

Masoomeh Kheirkhah ◽

Mojgan Rajati ◽

hamid haghani

Keyword(s):

Clinical Trial ◽

Pregnant Women ◽

Control Group ◽

Controlled Clinical Trial ◽

Control Groups ◽

Childbirth Experience ◽

Nulliparous Women ◽

Significant Difference ◽

The Mean ◽

And Control

Abstract Background Childbirth is a unique experience that affects women’s life. Therefore, this study was performed to determine the effect of delivery ball and warm shower on the childbirth experience of primiparous women. Methods This study is a clinical trial that was carried out on primiparous pregnant women referred to Motazedi Hospital in Kermanshah, Iran. Sampling was done by continuous method and pregnant women were divided into three groups of delivery ball-warm shower (n = 33), delivery ball (n = 33) and control (n = 33). Exercise with ball at the dilation of 4 cm was similar in the two groups of delivery ball-warm shower and delivery ball, but the first group also used warm shower at the dilatation of 7 cm. The control group only received the routine delivery care. Demographic information form consisting of pregnancy history and information about the mother and infant were completed and the childbirth experience questionnaire (CEQ) were completed by the women two hours after the childbirth. Results There was a statistically significant difference in the mean score of childbirth experience after the intervention between the two groups of delivery ball-warm shower and control (P = 0.001), and also between the delivery ball and control groups (P = 0.001). There was a statistically significant difference in the mean scores of professional support between the two groups of delivery ball-warm shower and control (P = 0.02) and also between the delivery ball and control groups (p = 0.02). There was a statistically significant difference in the mean scores of participation between the two groups of delivery ball-warm shower and control (P = 0.003) and also between the delivery ball and control groups (P = 0.01). There was also a statistically significant difference in the mean scores of sense of security between the two groups of delivery ball-warm shower and control (P = 0.01). Conclusion Delivery ball and warm shower were effective interventions to create a positive childbirth experience. This method was more effective than using delivery ball alone in childbirth experience. To achieve a positive experience of childbirth in mothers, the use of both intervention (delivery ball and warm shower) is recommended.

Download Full-text

Eremostachys laciniata as effective as rectal diclofenac suppository in cesarean section pain relief: A triple-blind controlled clinical trial

Journal of Endometriosis and Pelvic Pain Disorders ◽

10.1177/2284026519899010 ◽

2020 ◽

Vol 12 (1) ◽

pp. 26-34

Author(s):

Shabnam Mohammad Pour ◽

Sevil Hakimi ◽

Abbas Delazar ◽

Yousef Javad Zadeh ◽

Fatemeh Mallah

Keyword(s):

Clinical Trial ◽

Cesarean Section ◽

Intervention Group ◽

Massive Hemorrhage ◽

Control Group ◽

Controlled Clinical Trial ◽

Total Extract ◽

Significant Difference ◽

Healing Score ◽

Distress Scale

Background: Pain and distress are two common complications of cesarean section. Among complementary therapies, Eremostachys was introduced as a pain mitigator. This study aimed at investigating the effect of Eremostachys laciniata on cesarean section pain and distress. Materials and methods: This randomized clinical trial was conducted on 86 women who gave childbirth by cesarean section. The control group received 50 mg rectal diclofenac suppository every 8 h for 3 days, and the intervention group received 35 mg E. laciniata total extract suppository every 8 h up to three doses. Pain was measured with the Visual Analogue Scale at 8, 16, and 24 h after cesarean section. The Symptom Distress Scale was completed at 8 and 24 h after cesarean section. The Redness, Edema, Ecchymosis, Discharge, Approximation scale was completed 5 days after cesarean section. Findings: Pain score at 8, 16, and 24 h after surgery (15 min after intervention) was not significantly different between the intervention and control groups. The distress score 24 h after cesarean section showed a significant difference in favor of the control group according to Friedman’s test. There was a significant difference between the two groups in wound healing score, which indicated better efficacy of rectal diclofenac suppository than E. laciniata suppository. We assessed nausea, vomiting, headache, massive hemorrhage, and any type of anaphylactic reaction. No side events were observed in two groups. Conclusion: Rectal E. laciniata suppository could be introduced as a low-complication, appropriate, and effective medication in controlling pain and distress after cesarean section; more studies should be conducted on this matter.

Download Full-text

The Efficacy of The Administration of BifidobacteriumLactis For Treatment of Infantile Colic: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

10.21203/rs.3.rs-730782/v1 ◽

2021 ◽

Author(s):

Mohammad Ali Pourmirzaiee ◽

Fatemeh Famouri ◽

Akram Kahid ◽

Silva Hovsepian ◽

Roya Kelishadi

Keyword(s):

Clinical Trial ◽

Control Group ◽

Controlled Clinical Trial ◽

Infantile Colic ◽

Double Blind ◽

Bifidobacterium Lactis ◽

Bifidobacterium Animalis ◽

Significant Difference ◽

Study Offer

Abstract The aim of this trial was to evaluate the efficacy of Bifidobacterium Lactis administration on infantile colic (IC). In this double blind randomized, placebo‐controlled clinical trial, infants with IC diagnosis, exclusive breastfeeding, gestational age more than 37 weeks and birth weight more than 2500 gram were included. The selected infants randomly allocated in the two groups of BBcare group, treated with Bifidobacterium animalis subsp. lactis and the control group treated with placebo, 5 drops per day, for 6 weeks. The mean of crying, vomiting episodes and defecation number at baseline and during follow ups (40 and 60 days after intervention) were compared between the two studied groups. In this study from initially enrolled neonates, 40 and 38 neonates in BB-12 and placebo groups completed the study. In BB-12 group number of defecation, crying and vomiting episodes decreased significantly during intervention till 60 days after probiotic administration(P<0.05).In the placebo group there was significant decrease for crying and vomiting episodes between baseline and 60 days after intervention(P<0.05). Between group analyses indicated that there was significant difference between groups regarding mean of crying and vomiting episodes and number of defecation ,60 days after intervention(P<0.05).Conclusion: Findings of our study offer compelling signals for the effectiveness of Bifidobacterium animalis subsp. lactis BB‐12 in the management of some intestinal problems. These findings could be supportive evidences for the important role of gut microbiota as goal of intervention to improvement in bowel movement and comfortable defecation in IC.

Download Full-text

Influence of hyperuricemia treatment on postoperative acute kidney injury among hyperuricemia patients: a single-center retrospective database analysis

BMC Research Notes ◽

10.1186/s13104-019-4783-1 ◽

2019 ◽

Vol 12 (1) ◽

Author(s):

Shinichiro Watanabe ◽

Takashi Kawano ◽

Taro Horino ◽

Tatsuki Matsumoto ◽

Keitaro Nagata ◽

...

Keyword(s):

Acute Kidney Injury ◽

Uric Acid ◽

Treatment Group ◽

Serum Creatinine ◽

Kidney Injury ◽

Control Group ◽

Database Analysis ◽

Significant Difference ◽

Retrospective Database Analysis ◽

Retrospective Database

Abstract Objective Hyperuricemia has been reported to be associated with the development of postoperative acute kidney injury (pAKI). However, it remains underdetermined whether hyperuricemia treatment could decrease the potential risk of pAKI. Here, we investigated this hypothesis among hyperuricemia patients with previously normal renal function by performing a retrospective database analysis. Results The study screened 18,169 patients, and were examined preoperative serum creatinine, uric acid, and postoperative serum creatinine. Eight hundred thirty-six patients were finally analyzed for the study, of whom 232 were in the treatment group and 604 were in the non-treatment control group. After adjustment for multi-covariates including baseline (pre-treatment) serum uric acid (SUA) levels, the incidence of pAKI in the treatment group (9.05%; 95% CI 6.04–12.1%) was significantly lower than that in the control group (14.2%; 95% CI 11.2–17.2%). On the other hand, further adjusting for preoperative SUA levels, there was no significant difference in the expected incidence of pAKI between the groups.

Download Full-text

Levocarnitine Injections Decrease the Need for Erythropoiesis-Stimulating Agents in Hemodialysis Patients with Renal Anemia

Cardiorenal Medicine ◽

10.1159/000462983 ◽

2017 ◽

Vol 7 (3) ◽

pp. 188-197 ◽

Cited By ~ 5

Author(s):

Takashi Maruyama ◽

Terumi Higuchi ◽

Toshio Yamazaki ◽

Erina Okawa ◽

Hideyuki Ando ◽

...

Keyword(s):

Hemodialysis Patients ◽

Renal Anemia ◽

Maintenance Hemodialysis ◽

Control Group ◽

Controlled Clinical Trial ◽

Human Erythropoietin ◽

Significant Difference ◽

Group 2 ◽

To Receive ◽

Esa Therapy

Aims: The aim of this study was to evaluate the efficacy of levocarnitine injection for renal anemia in hemodialysis patients. Methods: In this randomized controlled clinical trial, we randomly assigned patients on maintenance hemodialysis at our hospital to receive levocarnitine injections (n = 30) or no injection (n = 30) and monitored the patients during 12 months of treatment. In the treatment group, patients received an injection of levocarnitine 1,000 mg 3 times weekly after hemodialysis sessions. All patients received recombinant human erythropoietin as an erythropoiesis-stimulating agent (ESA). Response to ESA therapy was determined by calculating the erythropoietin responsiveness index (ERI; ESA dose·kg-1·g-1· dL-1·week-1). Results: (1) The target levels of hemoglobin and hematocrit were maintained during the study period in both the levocarnitine group and the control group. (2) The dose of ESAs required to maintain these levels decreased gradually in the levocarnitine group and was significantly lower at 6 and 12 months than at study initiation. Furthermore, the dose of ESAs was significantly lower than that in the control group at 12 months. (3) The ERI showed a significant decrease at 6 and 12 months in the levocarnitine group, with a significant difference between the 2 groups at 12 months. Conclusion: Our results suggest that levocarnitine administration can reduce the dose of ESAs required in patients with renal anemia on hemodialysis and improve the response to ESA therapy.

Download Full-text