End-stage renal disease
Conditions
Interventions
Glucose peritoneal dialysis fluid group:none
Amino acid (15) peritoneal dialysis fluid group:none
Amino acid (15) peritoneal dialysis fluid plus a -keto acid tablets group:none
Sponsors
The First Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: The observed subjects must meet all of the following conditions before they can be included in the study: 1. 18 to 80 years old, gender not limited. 2. Plan to receive peritoneal dialysis treatment for >= 6 months, and there is no plan to switch to hemodialysis during the study period; 3. The criterion for malnutrition is 25g/L<= serum albumin level <=35g/L and at least one of the following two conditions is met: (1) Prealbumin (PAB)<300mg/L; (2) Among the eight items of the Subjective Overall Assessment (SGA), at least five items are classified as grade C or Grade B. 4. No a -keto acid preparations were used at least 4 weeks before enrollment; 5. The patient or their family members can understand the research protocol and are willing to participate in this study, and sign the written informed consent form. 6. Patients who voluntarily participated in this study and agreed to be treated with this protocol.
Exclusion criteria
Exclusion criteria: The observed object will be excluded if it meets any of the following conditions: 1. There are diseases that affect peritoneal function or abdominal cavity integrity: (1) Unhealed peritoneal rupture or septal rupture; (2) Abdominal tumors, abdominal wall infections, hernias; (3) Colostomy, ileostomy or frequently recurrent diverticulitis; (4) Inflammatory or ischemic bowel disease. 2. Contraindications for amino acids (15) peritoneal dialysis fluid: (1) Allergy to the research drug or any of its components; (2) Serum urea level > 38 mmol/l; (3) Uremic symptoms were present during screening, such as obvious loss of appetite, nausea, vomiting, etc. (4) Metabolic acidosis, with carbon dioxide binding capacity (CO2CP) 3 times the upper limit of normal (>120 U/L). If there is active liver injury or abnormal liver function, it needs to be excluded or stabilized before inclusion in the group. (7) Severe hypokalemia, with serum potassium (K?) <2.5 mmol/L; (8) Uncorrectable mechanical defects that affect therapeutic efficacy or increase the risk of infection; (9) Those with a history of peritoneal function loss or those whose peritoneal function is affected by extensive adhesions. 3. Suffering from malignant tumors or with an expected lifespan of less than 6 months; 4. Pregnant or lactating women; 5. Exclude patients with severe mental disorders who are unable to cooperate with the research requirements; 6. Other circumstances where the researcher deems it may not be suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The differences in serum albumin (ALB) levels and prealbumin (PAB) levels of patients in each group 6 months after treatment from the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The differences in serum albumin (ALB) levels and prealbumin (PAB) levels of patients in each group 3 months after treatment from the baseline;The differences in serum urea nitrogen (BUN) levels between each group of patients at 3 months and 6 months after treatment and the baseline;The differences in the subjective global assessment (SGA) scores of each group of patients at 3 and 6 months after treatment from the baseline;The differences in C-reactive protein (CRP) levels between each group of patients at 3 months and 6 months after treatment and the baseline;The differences in the quality of life scores (KDQOL-36 scale) of patients in each group at 3 and 6 months after treatment compared with the baseline;The differences in peritoneal transport function of patients in each group 6 months after treatment compared with the baseline;The differences in hemoglobin (Hb) levels between each group of patients at 3 and 6 months after treatment and the baseline;The differences in serum calcium, phosphorus and parathyroid hormone (iPTH) levels between each group of patients at 3 and 6 months after treatment and the baseline;The differences in dialysis adequacy assessment indicators of patients in each group 6 months after treatment compared with the baseline;The all-cause mortality rates of patients in each group at 3 months and 6 months after treatment; | — |
Countries
China
Contacts
Public ContactXu Guoshuang
The First Affiliated Hospital of Air Force Medical University
Outcome results
None listed