Abdominal dialysis patients with combined malnutrition
Conditions
Interventions
Control group:Glucose peritoneal dialysis solution [lactate-G1.5%]
Experimental group:Amino acid (15) peritoneal dialysis solution
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.18 = 3 months and have no planned kidney transplantation during the study period; 3.Meet the criteria for protein energy expenditure (PEW) diagnosis (International Society of Nephrology Nutrition and Metabolism [ISRNM], 2008), i.e. at least 2 out of the following 3 criteria, and serum ALB 5% within 3 months or>10% within 6 months; Or body fat percentage5% within 3 months or>10% within 6 months; Or the decrease in upper arm muscle circumference is greater than the median upper arm circumference of the reference population by 10%; 4.The dialysis plan meets the weekly total Kt/V requirement of >= 1.7; 5.Patients or their families are able to understand the research protocol and are willing to participate in this study, and sign a written informed consent form; 6.The patient has good compliance and voluntarily accepts follow-up, treatment, laboratory tests, and other research steps according to the plan.
Exclusion criteria
Exclusion criteria: 1.Contraindications for amino acid (15) peritoneal dialysis fluid: (1) Allergic to the investigational drug or any of its components;(2) Serum urea level>38 mmol/L; (3) There are symptoms of uremia during screening, such as significant loss of appetite, nausea, vomiting, etc; (4) Irreversible metabolic acidosis: CO2CP3 times the upper limit of normal values, total bilirubin>2 times the upper limit of normal values; (7) Active hepatitis, active hepatitis B or C, cirrhosis, active liver disease, or positive for human immunodeficiency virus (HIV) serum reaction; (8) Severe hypokalemia that cannot be corrected: serum potassium = 2.5 mmol/L; (9) There are uncorrectable mechanical defects that affect therapeutic efficacy or increase the risk of infection; (10) History of loss of peritoneal function or severe impact on peritoneal function due to extensive adhesions; 2.diabetes patients with poor blood glucose control (HbA1c>8.5%); 3.Have suffered from peritonitis within the past 3 months before the screening period, or have not fully recovered from the effects of previous peritonitis when participating in the trial; 4.Severe gastrointestinal diseases, such as gastrointestinal bleeding, intestinal obstruction, severe indigestion, inflammatory bowel disease, etc; 5.If there is malignant tumor or the expected survival period determined by the researcher is less than 6 months; 6.Pregnant or lactating women of childbearing age do not agree to use effective contraceptive measures during the trial period; 7.Currently participating in other intervention studies; 8.Researchers believe that patients are not suitable for any other circumstances to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prealbumin,PAB;Serum albumin,ALB; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum albumin,ALB;Prealbumin,PAB; | — |
Countries
China
Contacts
Public ContactXiaofang Yu
Zhongshan Hospital, Fudan University
Outcome results
None listed