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
Study to Evaluate Amino Acid (15) Peritoneal Dialysis Solution Compared to Glucose Solution in Malnourished Peritoneal Dialysis Patients with End Stage Renal Disease
Led by Chengdu Qingshan Likang Pharmaceutical Co., Ltd · Updated on 2024-12-30
400
Participants Needed
21
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of an amino acid (15) peritoneal dialysis solution in people with end stage renal disease (ESRD) who are undergoing peritoneal dialysis and have malnutrition. This Phase IV, multicenter, randomized study compares this amino acid solution with the standard glucose peritoneal dialysis solution in patients receiving continuous ambulatory peritoneal dialysis (CAPD) maintenance therapy. The goal is to understand how this new dialysis solution may impact patients' nutritional status and overall health. Participants are randomly assigned to one of two groups. The experimental group receives one 2-liter bag of amino acid (15) peritoneal dialysis solution each morning, followed by conventional glucose peritoneal dialysate (lactate). The control group receives conventional glucose peritoneal dialysis solution including a 2-liter bag of 1.5% glucose peritoneal dialysis solution daily. Researchers adjust the number of exchanges, fluid volume, and dwell time based on patient needs. The treatment period lasts 90 days. During the study, participants undergo blood routine and biochemical tests at 30, 60, and 90 days to monitor safety and effects. Nutritional and dialysis-related measures such as normalized protein nitrogen appearance (nPNA), arm muscle circumference (AMC), mid-arm muscle circumference (MAMC), subjective global assessment (SGA), body mass index (BMI), and dialysis adequacy (Kt/V) are evaluated at 90 days. Researchers also record total daily ultrafiltration volume and any adverse events throughout the treatment. The study aims to assess the impact of the dialysis solutions on patients' nutrition and safety over the three-month period.
CONDITIONS
Official 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 old, any gender
- Stable CAPD patients treated with peritoneal dialysis for 3 months or longer
- Serum albumin between 25 and 40 g/L on two occasions one week apart before enrollment
- Blood potassium level at or above 3.5 mmol/L
- C-reactive protein (CRP) at or below twice the upper limit of normal
- Carbon dioxide binding capacity above 18 mmol/L
- Voluntary written informed consent and willingness to follow the study protocol
You will not qualify if you...
- History of peritonitis, infections, or inflammatory diseases requiring hospitalization in the 3 months before screening
- Potential kidney transplant planned during the study
- 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 before screening
- Recent bleeding events, serious cardiovascular or cerebrovascular events within 30 days before screening
- Active diarrhea affecting nutrient absorption during screening (except chronic diarrhea with stool frequency less than 3 times per day)
- Allergies to amino acid dialysis solutions or related metabolic disorders
- Active liver disease or positive HIV within 6 months before screening
- Mechanical defects affecting treatment or increasing infection risk
- History of peritoneal function loss or impairment due to adhesions
- Malignant tumor or life expectancy under 6 months
- Routine use of 4.25% glucose dialysis solution during screening
- Poorly controlled diabetes with HbA1c over 8%
- Pregnant or breastfeeding women
- Any other conditions deemed unsuitable by the investigator
AI-Screening
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1
2
3
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