A Randomized Clinical Trial with a 0.6% Amino Acid/1.4% Glycerol Peritoneal Dialysis Solution

2004 ◽  
Vol 24 (3) ◽  
pp. 222-230 ◽  
Author(s):  
Wim Van Biesen ◽  
Walter Boer ◽  
Bart De Greve ◽  
Clement Dequidt ◽  
Denise Vijt ◽  
...  

Background Glucose is an accepted osmotic agent for peritoneal dialysis (PD) although it has several drawbacks. Some of these drawbacks have been addressed by the introduction of solutions with low glucose degradation products and physiological pH in dual-chambered bags. Despite this achievement, there is a need for alternative osmotic agents. This randomized clinical trial analyzes 3-month's clinical experience with a mixture of 0.6% amino acids and 1.4% glycerol. Methods The study was performed at the renal units of the University Hospitals Ghent, Belgium, and Utrecht, The Netherlands. Stable PD patients were randomized for either protocol A (test solution, n = 5) or protocol B (control regimen, n = 5). In both protocols, there was a run-in phase of 1 month with a dialysis regimen of 2 × 2 L 2.27% glucose solution (Dianeal; Baxter, Nivelles, Belgium), 1 × 2 L Extraneal (Baxter), and 1 × 2 L glucose solution (Dianeal). After this month-long run-in period, patients in group A received during 3 months 2 × 2 L amino acid/glycerol solution, 1 × 2 L Extraneal, and at least 1 × 2 L of a classic glucose solution. Results Glucose absorption decreased in the test group during the test phase (from 84.2 ± 8.7 to 11.7 ± 11.6 g/24 hours, p = 0.001). Dialysate levels of cancer antigen 125 (CA125) increased in the test group, from 17.5 ± 11.0 to 32.4 ± 4.6 units/L ( p = 0.04), whereas, in the control group, the levels remained stable (15.5 ± 8.7 and 14.9 ± 9.8 units/L respectively, p = 0.4). There were no differences in serum urea, serum bicarbonate, serum osmolarity, serum albumin, or parameters related to skin-fold thickness or serum glycerol levels between control and test solutions. No differences were observed in obtained ultrafiltration after a 4-hour dwell with 2.27% glucose or the test solution, both measured at week 4 of the run-in period and week 12 of the test period. Conclusion This study demonstrated that the use of a new 0.6% amino acid/1.4% glycerol-containing dialysis solution is safe and well tolerated. Glucose load was reduced significantly and dialysate CA125 levels improved significantly. Ultrafiltration was comparable with that of a 2.27% glucose solution. All these factors, in combination with the potential nutritional benefits, can contribute to a beneficial impact on the success of the PD technique. Further long-term studies in larger patient groups are warranted to explore the potential of this promising new solution.

1999 ◽  
Vol 19 (5) ◽  
pp. 462-470 ◽  
Author(s):  
Alicja E. Grzegorzewska ◽  
Irena Mariak ◽  
Agnieszka Dobrowolska–Zachwieja ◽  
Lech Szajdak

Objective To evaluate the influence of 1.1% amino acid dialysis solution (AADS) on parameters of nutrition in continuous ambulatory peritoneal dialysis (CAPD) patients. Study Design Studies were performed in 8 men, using AADS for the overnight exchange. Before starting AADS, food intake, nutritional status, and laboratory indices were evaluated and compared to the respective parameters obtained after 3 and 6 months of treatment with AADS, as well as after 3 months of AADS withdrawal. With the start of AADS, doses of antacids were increased and modified during AADS administration; the modified doses were continued through 3 months after cessation of AADS. Another group of CAPD patients using standard dialysis solutions served as controls. In these patients the same parameters were evaluated four times at 3-month intervals. Results Administration of AADS resulted in: (1) 91% absorption of amino acids and improvement of serum amino acid pattern; (2) no change in nutritional intake during the treatment, but after the 3 months of AADS therapy, levels of nutrient intake were lower than those 3 months after withdrawal of AADS with correction of metabolic acidosis; (3) no change in indices of nutritional status, but 3 months after AADS discontinuation, total body weight, lean body mass, and body mass index were significantly higher than those shown after 3 months of treatment; (4) an increase in hemoglobin concentration, hematocrit, BUN, and blood H+. The examined parameters were not significantly changed in patients treated for 9 months with standard dialysis solutions exclusively. The values of nitrogen balance obtained during AADS administration and after 3 months of AADS withdrawal were significantly higher than those obtained in the respective periods in the control group. The blood pH, pCO2, and HCO3– in the last period of the study were higher in the AADS group than in the control group. Conclusion In relatively well-nourished CAPD patients, overnight AADS administration results in increased serum concentration of amino acids without changes in other nutritional parameters. The use of AADS should be associated with increased doses of antacid medication, which abolishes the metabolic effects of acidosis that develop during AADS administration and facilitates positive nitrogen balance.


2016 ◽  
Vol 17 (1) ◽  
pp. 7-15 ◽  
Author(s):  
Ronald Younes ◽  
Antoine Berberi ◽  
Nabih Nader ◽  
Maissa Aboulhosn ◽  
Cordahi Manal

ABSTRACT Background The periimplant bone level has been used as one of the criteria to assess the success of dental implants. It has been documented that the bone supporting two-piece implants undergoes resorption first following the second-stage surgery and later on further to abutment connection and delivery of the final prosthesis. Objective The aim of this multicentric randomized clinical trial was to evaluate the crestal bone resorption around internal connection dental implants using a new surgical protocol that aims to respect the biological distance, relying on the benefit of a friction fit connection abutment (test group) compared with implants receiving conventional healing abutments at secondstage surgery (control group). Materials and methods A total of partially edentulous patients were consecutively treated at two private clinics, with two adjacent two-stage implants. Three months after the first surgery, one of the implants was randomly allocated to the control group and was uncovered using a healing abutment, while the other implant received a standard final abutment and was seated and tightened to 30 Ncm. At each step of the prosthetic try-in, the abutment in the test group was removed and then retightened to 30 Ncm. Horizontal bone changes were assessed using periapical radiographs immediately after implant placement and at 3 (second-stage surgery), 6, 9 and 12 months follow-up examinations. Results At 12 months follow-up, no implant failure was reported in both groups. In the control group, the mean periimplant bone resorption was 0.249 ± 0.362 at M3, 0.773 ± 0.413 at M6, 0.904 ± 0.36 at M9 and 1.047 ± 0.395 at M12. The test group revealed a statistically significant lower marginal bone loss of 20.88% at M3 (0.197 ± 0.262), 22.25% at M6 (0.601 ± 0.386), 24.23% at M9 (0.685 ± 0.341) and 19.2% at M9 (0.846 ± 0.454). The results revealed that bone loss increased over time, with the greatest change in bone loss occurring between 3 and 6 months. Alveolar bone loss was significantly greater in the control condition than the test condition. Conclusion The results of this prospective study demonstrated the benefit of placing a prosthetic component with a stable connection at second-stage surgery, in terms of reduced marginal bone remodeling when compared with conventional procedure. Clinical significance. The use of a stable connection in a healing component during try-in stages prior to final restoration placement leads to less periimplant marginal bone loss. How to cite this article Nader N, Aboulhosn M, Berberi A, Manal C, Younes R. Marginal Bone Remodeling around healing Abutment vs Final Abutment Placement at Second Stage Surgery: A 12-month Randomized Clinical Trial. J Contemp Dent Pract 2016;17(1):7-15.


2020 ◽  
Vol 8 (11) ◽  
pp. 1806
Author(s):  
Inpyo Hong ◽  
Hyun Gee Lee ◽  
Hye Lim Keum ◽  
Myong Ji Kim ◽  
Ui-Won Jung ◽  
...  

(1) Background: Dental calculus works as a niche wherein pathogenic bacteria proliferate in the oral cavity. Previous studies revealed the anticalculus activity of pyrophosphates, however there was no clinical study that evaluated microbiome changes associated with calculus inhibition. Therefore, the aim of this randomized clinical trial was to evaluate the calculus inhibition of pyrophosphate-containing toothpaste and its effect on oral microbiome changes. (2) Methods: Eighty subjects with a calculus index ≥2 on the lingual of the mandibular anterior tooth were randomly allocated to the test group that pyrophosphate-containing toothpaste was given to or the placebo control group. Full mouth debridement and standardized tooth brushing instruction were given before the allocation. Plaque index, gingival index, calculus index, probing depth, and bleeding on probing were measured at the baseline, and at 4, 8 and 12 weeks. Genomic DNA was extracted from the plaque samples collected at the baseline and at 12 weeks, and 16S ribosomal RNA gene amplicon sequencing was applied for microbiome analysis. (3) Results: None of the clinical parameters showed significant differences by visits or groups, except the plaque index of the test group, which reduced significantly between 4 and 12 weeks. A significant difference of microbiome between the baseline and 12 weeks was observed in the test group. Between baseline and 12 weeks, the proportion of Spirochetes decreased in the control group, and the proportions of Proteobacteria, Fusobacteria and Spirochetes in the phylum level and the proportions of Haemophilus, Fusobacterium and Capnocytophaga in the genus level decreased in the test group. In the test group, as plaque index decreased, Streptococcus increased, and Fusobacterium and Haemophilus parainfluenza decreased. (4) Conclusion: The use of pyrophosphate-containing toothpaste effectively inhibited the dysbiosis of the oral microbiome and the proliferation of pathogenic species in periodontal disease. Clinically, plaque formation in the pyrophosphate-containing toothpaste group was effectively decreased, however there was no significant change in calculus deposition.


2018 ◽  
Vol 29 (3) ◽  
pp. 290-295 ◽  
Author(s):  
Luciana Bitello-Firmino ◽  
Vanessa Kern Soares ◽  
Nailê Damé-Teixeira ◽  
Clarissa Cavalcanti Fatturi Parolo ◽  
Marisa Maltz

Abstract The aim of this randomized clinical trial was to compare the remaining microbial load after treatments based on complete and selective caries removal and sealing. Patients with active carious lesions in a permanent molar were randomly allocated into 2 groups: a test group (selective caries removal-SCR; n=18) and a control group (complete caries removal - CCR; n=18). Dentin samples were collected following the excavation and three months after sealing. Streptococcus species, Streptococcus mutans, Lactobacillus species, and total viable microorganisms were cultured to count the viable cells and frequency of species isolation. CCR resulted in significant lower total viable microorganisms counts (p≤0.001), Streptococcus species (p≤0.001) and Lactobacillus species (p≤0.001) initially. However, after sealing, a decrease in total viable microorganisms, Streptococcus species, and Lactobacillus species in the SCR resulted in no difference between the groups after 3 months. In conclusion, selective caries removal is as effective as complete caries removal in reducing dentin bacterial load 3 months after sealing.


2012 ◽  
Vol 53 (1) ◽  
pp. 27-31 ◽  
Author(s):  
Patricia Blaya Luz ◽  
Cecilia Romero Meller ◽  
Sonia Blauth Slawutsky ◽  
Juliana Sarmento Barata ◽  
Fernando Borba de Araújo

Purpose: The aim of the present study was to compare the acceptability of the ART and the conventional restoration approaches in children. Methods: The sample of the current randomized clinical trial was 30 children 4 to 7 years old who had at least one class II active cavity in a primary molar that was accessible to hand instruments. The treatment groups were: Control Group- treatment with local anesthesia, rubber dam, rotary instruments and composite resin. Test Group- treatment according to ART approach using only hand instruments, no anesthesia and glass ionomer. In both groups, only the demineralized carious tissue and unsupported enamel were removed. The acceptability of the two groups was assessed by measuring the emotional feelings represented by Face Image Scale (FIS) before and after the procedure. Results: There was no significant difference between the two groups regarding changes in FIS scores. Fifty percent of the children from the Test Group got more satisfied after the procedure, while 64% of the participants from Control Group did not change their feelings. Conclusion: The ART approach had not demonstrated to have a best acceptability then the conventional approach. However the short time taken to complete the procedure seems to be worthy aspects when dealing with very young children or patients with behaviors problems.


2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Somayeh Makaremnia ◽  
Marieh Dehghan Manshadi ◽  
Zahra Khademian

Abstract Background Thalassemia have a negative impact on the patients' psychological health and sleep quality. This study aimed to determine the effects of a positive thinking training program on hope and sleep quality of patients with thalassemia major. Methods This randomized clinical trial was conducted on 78 patients with thalassemia major including 36 males (46.2%) and 42 females (53.8%) with a mean age of 25.56 ± 29.6 in Iran. Subjects were randomly assigned into experimental and control groups. Experimental group received 16 h training based on positive thinking materials published by Martin Seligman. Control group received only usual programs. Data were collected at baseline, as well as immediately and one month after the intervention, using Snyder’s Hope Scale and the Pittsburgh Sleep Quality Index. Data analysis was performed using SPSS Software 18.0; statistical tests included the independent T-test, the Chi-square, Mann Whitney, and Friedman test. Significance level was set at 0.05 in this study. Results The experimental group had a significantly higher mean hope score compared to the control group immediately (45.38 ± 7.82 vs. 35.32 ± 5.54, P < 0.001) and one month following intervention (44.67 ± 3.47 vs. 35 ± .54, P < 0.001). Moreover, the mean sleep quality scores of the experimental group was significantly greater than that for control group immediately (5.35 ± 2.02 vs. 7 ± 2.4, P = 0.004) and one month after the intervention (4.23 ± 2.2 vs.7.02 ± 3.03, P < 0.001). Conclusion Since our training program on positive thinking improved hope and quality of sleep in patients with thalassemia major, we recommend the use of such courses as an important step toward promotion of hope and sleep quality among these patients. Trial registration The name of the registry: Iranian Registry of Clinical Trials. Trial Registration Number: IRCT2017010431774N1. URL of the trial registry record: https://en.irct.ir/trial/24923. Registration Date: 07/03/2017.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Federico Longhini ◽  
Laura Pasin ◽  
Claudia Montagnini ◽  
Petra Konrad ◽  
Andrea Bruni ◽  
...  

Abstract Background Post-operative pulmonary complications (PPC) can develop in up to 13% of patients undergoing neurosurgical procedures and may adversely affect clinical outcome. The use of intraoperative lung protective ventilation (LPV) strategies, usually including the use of a low Vt, low PEEP and low plateau pressure, seem to reduce the risk of PPC and are strongly recommended in almost all surgical procedures. Nonetheless, feasibility of LPV strategies in neurosurgical patients are still debated because the use of low Vt during LPV might result in hypercapnia with detrimental effects on cerebrovascular physiology. Aim of our study was to determine whether LPV strategies would be feasible compared with a control group in adult patients undergoing cranial or spinal surgery. Methods This single-centre, pilot randomized clinical trial was conducted at the University Hospital “Maggiore della Carità” (Novara, Italy). Adult patients undergoing major cerebral or spinal neurosurgical interventions with risk index for pulmonary post-operative complications > 2 and not expected to need post-operative intensive care unit (ICU) admission were considered eligible. Patients were randomly assigned to either LPV (Vt = 6 ml/kg of ideal body weight (IBW), respiratory rate initially set at 16 breaths/min, PEEP at 5 cmH2O and application of a recruitment manoeuvre (RM) immediately after intubation and at every disconnection from the ventilator) or control treatment (Vt = 10 ml/kg of IBW, respiratory rate initially set at 6–8 breaths/min, no PEEP and no RM). Primary outcomes of the study were intraoperative adverse events, the level of cerebral tension at dura opening and the intraoperative control of PaCO2. Secondary outcomes were the rate of pulmonary and extrapulmonary complications, the number of unplanned ICU admissions, ICU and hospital lengths of stay and mortality. Results A total of 60 patients, 30 for each group, were randomized. During brain surgery, the number of episodes of intraoperative hypercapnia and grade of cerebral tension were similar between patients randomized to receive control or LPV strategies. No difference in the rate of intraoperative adverse events was found between groups. The rate of postoperative pulmonary and extrapulmonary complications and major clinical outcomes were similar between groups. Conclusions LPV strategies in patients undergoing major neurosurgical intervention are feasible. Larger clinical trials are needed to assess their role in postoperative clinical outcome improvements. Trial registration registered on the Australian New Zealand Clinical Trial Registry (www.anzctr.org.au), registration number ACTRN12615000707561.


2021 ◽  
pp. 1357633X2110096
Author(s):  
Maria KEF Feijó ◽  
Karen Brasil Ruschel ◽  
Daniela Bernardes ◽  
Eduarda B Ferro ◽  
Luis E Rohde ◽  
...  

Introduction The aim of this study was to evaluate the effectiveness of a diuretic adjustment algorithm (DAA) in maintaining clinical stability and reducing HF readmissions using telemonitoring Technologies. Methods Randomized clinical trial of patients with an indication for furosemide dose adjustment during routine outpatient visits. In the intervention group (IG), the diuretic dose was adjusted according to the DAA and the patients received telephone calls for 30 days. In the control group (CG), the diuretic dose was adjusted by a physician at baseline only. Co-primary outcomes were hospital readmission and/or emergency department visits due to decompensated HF within 90 days, and a 2-point change in the Clinical Congestion Score and/or a deterioration in New York Heart Association functional class within 30 days. Results A total of 206 patients were included. Most patients were male ( n=119; 58%), with a mean age of 62 (SD 13) years. Four patients (2%) in the IG and 14 (7%) in the CG were hospitalized for HF (odds ratio (OR) 0.31 (0.10–0.91); p=0.04). Multivariate analysis showed a reduction of 67% in readmissions and/or emergency department visits due to decompensated HF in the IG compared with the CG (95% CI 0.13–0.88; p=0.027). Regarding the combined outcome of HF readmission and/or emergency department visits or clinical instability, the IG had 20% fewer events than the CG within 30 days (IG: n=48 (23%), CG: n=70 (34%); OR 0.80 (0.63–0.93); p=0.03). Discussion Using DAA improved the combined outcome in these outpatients, with favorable and significant results that included a reduction in HF admissions and in clinical instability. (NCT02068937)


BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Christine Elizabeth Jones ◽  
Anna Calvert ◽  
Jo Southern ◽  
Mary Matheson ◽  
Nick Andrews ◽  
...  

Abstract Background Pertussis vaccines containing three or five pertussis antigens are recommended in pregnancy in many countries, but no studies have compared the effect on infants’ antigen-specific immunoglobulin G (IgG) concentrations. The aim of this study was to compare anti-pertussis IgG responses following primary immunization in infants of mothers vaccinated with TdaP5-IPV (low dose diphtheria toxoid, tetanus toxoid, acellular pertussis [five antigens] and inactivated polio) or TdaP3-IPV in pregnancy (three pertussis antigens). Methods This multi-centre phase IV randomized clinical trial was conducted in a tertiary referral centre and primary care sites in England. Women were randomized to receive TdaP5-IPV (n = 77) or TdaP3-IPV (n = 77) at 28–32 gestational weeks. A non-randomized control group of 44 women who had not received a pertussis-containing vaccine in pregnancy and their 47 infants were enrolled post-partum. Results Following infant primary immunization, there was no difference in the geometric mean concentrations (GMCs) of anti-pertussis toxin, filamentous haemagglutinin or pertactin IgG between infants born to women vaccinated with TdaP5-IPV (n = 67) or TdaP3-IPV (n = 63). However, the GMC of anti-pertussis toxin IgG was lower in infants born to TdaP5-IPV- and TdaP3-IPV-vaccinated mothers compared to infants born to unvaccinated mothers (n = 45) (geometric mean ratio 0.71 [0.56–0.90] and 0.78 [0.61–0.98], respectively); by 13 months of age, this difference was no longer observed. Conclusion Blunting of anti-pertussis toxin IgG response following primary immunization occurs in infants born to women vaccinated with TdaP5-IPV and TdaP3-IPV, with no difference between maternal vaccines. The blunting effect had resolved by 13 months of age. These results may be helpful for countries considering which pertussis-containing vaccine to recommend for use in pregnancy. Trial registration ClinicalTrials.gov, NCT02145624, registered 23 May 2014


2002 ◽  
Vol 22 (3) ◽  
pp. 357-364 ◽  
Author(s):  
Alicja E. Grzegorzewska ◽  
Danuta Antczak-Jȩdrzejczak ◽  
Magdalena Leander

Background Results of peritoneal equilibration test (PET) suggest prolonged effect of polyglucose dialysis solution (PG-DS) on peritoneal permeability. Objectives An evaluation of dialysate-to-plasma ratio (D/P) of urea, D/P creatinine, and D/D0 glucose (ratio of dialysate glucose at designated dwell time to dialysate glucose at 0 dwell time), and mass transfer area coefficients (KBD) of these solutes in PET before introduction, during administration, and after discontinuation of PG-DS in patients treated with continuous ambulatory peritoneal dialysis (CAPD). Design Single-center prospective study with PG-DS; retrospective selection of the control group. Setting Peritoneal dialysis unit in a university hospital. Patients Fourteen patients (11 males; age 45.1 ± 8.5 years) treated with CAPD for 17.5 ± 9.9 months. 7.5% PG-DS was used for the overnight exchange. After discontinuation of the PG-DS, standard dialysis solutions, as previously used, were reintroduced. The control group was selected to match both CAPD duration and peritoneal permeability of the patients in the PG-DS group at the start of the study. Methods Standard PET was carried out at 1.6 ± 0.8 months before the introduction of PG-DS (study period I, n = 14), after 1.2 ± 0.6 months’ use of PG-DS (study period II, n = 14), after 4.4 ± 0.8 months’ use of PG-DS (study period III, n = 11), after 8.8 ± 2.2 months’ use of PG-DS (study period IV, n = 9), and at 2.0 ± 0.6 months after PG-DS discontinuation (study period V, n = 11). Patients in the control group underwent PET at similar time intervals (control periods I – V). Results In the PG-DS group, a tendency toward increased peritoneal permeability for urea and creatinine was shown during the consecutive study periods. D/D0 glucose was significantly higher only in the PET performed during use of PG-DS (periods II – IV) compared to results obtained in period I. In the control group, both D/P and KBD of both urea and creatinine remained unchanged, but KBD glucose was higher in the first 2 hours of the PET in control period V compared to respective values in control period III. Conclusion Changes in peritoneal permeability are observed in CAPD patients treated with PG-DS. These changes may be at least partially related to the administration of polyglucose.


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