Actual diet and nutritional deficiencies status in children on peritoneal dialysis at the Vietnam National Hospital of Pediatrics.
Luu Thi My Thuc, Nguyen Quang Dung, Vu Ngoc Ha...
https://pubmed.ncbi.nlm.nih.gov/31464251Actively Recruiting
Phase 4
Age: 18Years - 75Years
All Genders
ID06597201
Multicenter, Prospective, Randomized Trial to Evaluate Amino Acid (15) Peritoneal Dialysis Solution Safety and Efficacy in Malnourished Peritoneal Dialysis Patients
Led by Chengdu Qingshan Likang Pharmaceutical Co., Ltd · Updated on 2024-12-30
400
Participants Needed
21
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of an amino acid (15) peritoneal dialysis solution in patients undergoing peritoneal dialysis who have malnutrition. This Phase IV, multicenter, randomized, parallel controlled study focuses on patients receiving continuous ambulatory peritoneal dialysis (CAPD) maintenance treatment. The goal is to compare the amino acid solution with conventional glucose peritoneal dialysis solution in this population with End Stage Renal Disease (ESRD). Participants are randomly assigned to one of two groups: an experimental group receiving one bag of amino acid (15) peritoneal dialysate (2 liters) each morning followed by conventional glucose dialysate, and a control group receiving conventional glucose peritoneal dialysis solution including 1.5% glucose dialysate (2 liters) once daily. The number of dialysate exchanges, fluid volume, and dwell times are adjusted based on individual patient needs. The treatment period lasts 90 days, during which safety and effectiveness are monitored. Participants undergo screening, baseline assessments, and regular monitoring throughout the study. Blood tests and biochemical markers are checked at 30, 60, and 90 days, including serum albumin, transferrin, and prealbumin levels. Nutritional and physical assessments such as subjective global assessment (SGA), arm muscle circumference (AMC), mid-arm muscle circumference (MAMC), body mass index (BMI), and protein nitrogen appearance (nPNA) are evaluated at 90 days. The study also tracks total daily ultrafiltration volume and records all adverse events. The entire participation timeline includes a screening period before treatment and close observation during the 90-day treatment phase.
CONDITIONS
Brief Title
Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any sex
- Stable continuous ambulatory peritoneal dialysis (CAPD) treatment for at least 3 months
- Serum albumin between 25 and 40 g/L on two occasions one week apart
- Blood potassium level of 3.5 mmol/L or higher
- C-reactive protein less than or equal to twice the upper limit of normal
- Carbon dioxide binding capacity greater than 18 mmol/L
- Voluntary written informed consent and willingness to comply with study protocol
You will not qualify if you...
- History of peritonitis, infections, or inflammatory diseases with hospitalization within 3 months prior to screening
- Potential to receive kidney transplant during the study period
- Inadequate dialysis with kt/v less than 1.4 during screening
- Hemoglobin less than 80 g/L during screening
- Use of amino acid (15) peritoneal dialysate within 6 months prior to screening
- Recent bleeding events or major cardiovascular/cerebrovascular events within 30 days before screening
- Active diarrhea affecting nutrient absorption during screening
- Contraindications to amino acid (15) peritoneal dialysis solution including hypersensitivity, high serum urea, uremic symptoms, metabolic abnormalities, liver disease, or HIV infection
- Mechanical defects affecting efficacy or infection risk
- History of peritoneal function loss or impairment
- Malignant tumors or life expectancy under 6 months
- Routine use of 4.25% glucose dialysis solution during screening
- Poorly controlled diabetes with HbA1c over 8%
- Pregnancy or breastfeeding
- Other conditions deemed inappropriate by investigators
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening visit
Baseline Assessment
Duration - Up to 3 days
Participants who pass screening are re-verified for eligibility and baseline measurements are collected before treatment starts.
1 baseline visit (in-person)
Treatment
Duration - 90 days
Participants receive daily peritoneal dialysis treatment with either amino acid (15) peritoneal dialysis solution or glucose peritoneal dialysis solution for nutritional support and dialysis.
Daily treatment with monitoring visits on Day 30, Day 60, and Day 90
Trial Site Locations
Total: 21 locations
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
Actively Recruiting
2
Peking University People&'s Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
3
Wuhan NO.1 Hospital
Wuhan, Hubei, China
Actively Recruiting
4
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
Actively Recruiting
5
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610000
Actively Recruiting
6
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Actively Recruiting
7
Ganzhou People's Hospital
Ganzhou, China
Actively Recruiting
8
Affiliated Hospital of Guangdong Medical University
Guangdong, China
Actively Recruiting
9
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
Actively Recruiting
10
The Affiliated Hospital of Southwest Medical University
Luzhou, China
Actively Recruiting
11
Meishan Hospital, West China Hospital, Sichuan University (Meishan People's Hospital)
Meishan, China
Actively Recruiting
12
Jiangsu Province Hosipital
Nanjing, China
Actively Recruiting
13
The Affiliated Hospital of Nanjing university Medical School
Nanjing, China
Actively Recruiting
14
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
Actively Recruiting
15
Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
Shanghai, China
Actively Recruiting
16
General Hospital of Northern Theater Command
Shenyang, China
Actively Recruiting
17
The Central Hospital of Wuhan
Wuhan, China
Actively Recruiting
18
Zhongshan Hospital Xiamen University
Xiamen, China
Actively Recruiting
19
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, China
Actively Recruiting
20
The Second People's Hospital of Yibin City
Yibin, China
Actively Recruiting
21
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Actively Recruiting
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Research Team
Q
Qian Deng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Treatment of malnourished CAPD patients with an amino acid based dialysate.
J D Kopple, D Bernard, J Messana...
https://pubmed.ncbi.nlm.nih.gov/7783413Amino Acid-based peritoneal dialysis solutions for malnutrition: new perspectives.
Hoey Lan Tjiong, Roel Swart, Jacobus W van den Berg...
https://pubmed.ncbi.nlm.nih.gov/19602603