malnutrition
Conditions
Interventions
Group DAA:patients undergo peritoneal dialysis once every morning using 2.0L of amino acid (15) peritoneal dialysis solution. This is followed by treatment with conventional low-calcium or regular per
Group NDAA:In the NDAA group, patients do not receive amino acid peritoneal dialysis solution and undergo treatment with conventional low-calcium or regular peritoneal dialysis solution (lactate), wit
Sponsors
Zhejiang Provincial Hospital of Chinese Medicine (The First Affiliated Hospital of Zhejiang Chinese Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Aged between 18 and 75 years (inclusive), with no restriction on gender; Patients undergoing continuous ambulatory peritoneal dialysis (CAPD) with stable treatment for at least 3 months; The dialysis regimen must include at least one bag of peritoneal dialysis solution (lactate-1.5%) or low-calcium peritoneal dialysis solution (lactate-1.5%); Serum albumin (ALB) levels between 25 and 35 g/L; Serum potassium = 3.5 mmol/L; C-reactive protein (CRP) = 2 times the upper limit of normal (ULN); Plasma bicarbonate > 22 mmol/L; At the time of enrollment, the dialysis regimen must meet a total weekly Kt/V of = 1.7; Subjects must voluntarily sign a written informed consent form before any study-related procedures, fully understanding the purpose and significance of the trial, and agreeing to comply with the study protocol.
Exclusion criteria
Exclusion criteria: Patients who have experienced peritonitis within the 3 months prior to the screening period; Patients who may undergo kidney transplantation during the study; Patients with contraindications for amino acid (15) peritoneal dialysis solution: (1) Those allergic to any component of the amino acid (15) peritoneal dialysis solution; (2) Serum urea levels > 38 mmol/L; (3) Presence of uremic symptoms at screening, such as significant loss of appetite, nausea, vomiting, etc.; (4) Various congenital amino acid metabolism disorders; Liver dysfunction within the 6 months prior to screening; active hepatitis, active hepatitis B or C, cirrhosis, active liver disease, or positive serology for human immunodeficiency virus (HIV); Patients with malignant tumors or an estimated lifespan of less than 12 months; Routine use of 4.25% glucose dialysis solution daily during the screening period; Diabetic subjects with a history of poor blood glucose control, such as HbA1c > 8%; Women who are pregnant or breastfeeding; Subjects who have used protein powders, protein component dietary supplements, special medical foods, or a-keto acids within the past month must undergo a washout period of two weeks prior to enrollment; Other conditions that the investigator believes may make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum albumin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum prealbumin;Serum transferrin;Serum urea nitrogen;Serum creatinine;Serum electrolytes;Serum total cholesterol;Serum Triglyceride;Low density lipoprotein cholesterol;High-density lipoprotein cholesterol;Serum uric acid;Ultrafiltration volume of peritoneal dialysis patients;Standardized protein nitrogen occurrence rate;Upper arm muscle circumference;Mid arm muscle circumference;Subjective comprehensive nutritional assessment level;Body mass index after draining peritoneal dialysis fluid;Serum Phosphate;Serum Calcium;parathyroid hormone;Height;Weight;Physical examination;Vital signs (hypertension, respiration, heart rate, heart rhythm, body temperature);erythrocyte;hemoglobin;hematocrit;MCV;MCH;mean corpuscular hemoglobin concentration;leukocyte;platelet;anc;Absolute value of lymphocytes;Absolute value of monocytes;Absolute value of eosinophils;Aspartate aminotransferase;Alanine aminotransferase;alkaline phosphatase;LDH;glutamyl transpeptidase;creatinine;total protein;globulin ratio;total bilirubin;Direct bilirubin;potassium;sodium;chlorine;calcium;phosphorus;magnesium;Fasting blood glucose;Serum total cholesterol;triglyceride;urinary protein;white blood cell count;red blood cell count;Infection markers; | — |
Countries
CHINA
Contacts
Public ContactQiang He
Zhejiang Provincial Hospital of Chinese Medicine (The First Affiliated Hospital of Zhejiang Chinese Medical University)
Outcome results
None listed