This is a multicenter, randomized, parallel controlled Phase IV clinical study to evaluate the safety and efficacy of amino acid (15) peritoneal dialysis solution in patients undergoing peritoneal dialysis with malnutrition in CAPD patients undergoing peritoneal dialysis maintenance.
After the subjects signed the informed consent, they entered the screening period (D-28 to D-1) for corresponding examination. Participants who were successfully screened were examined at baseline (D-3 to D-1) to re-verify the inclusion criteria. After re-verification of successful screening subjects, they were enrolled in 1:1 parallel groups according to the research center: experimental group treated with amino acid (15) peritoneal dialysate; Control group - glucose peritoneal dialysate treatment. Subjects were randomly enrolled and given the experimental drug from the next morning according to the randomized results. Subjects in the experimental group were treated with 1 bag of amino acid (15) peritoneal dialysate (2L) once a day in the morning, and were subsequently treated with conventional glucose peritoneal dialysate (lactate). Control subjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysis solution (lactate) (2L) once. The number of peritoneal dialysate exchange, the amount of fluid exchange and the duration of abdominal retention were adjusted by the researchers according to the specific conditions of the patients. Efficacy and safety were observed during the treatment period (D1-D90). Blood routine and blood biochemistry were monitored for 30 days, 60 days and 90 days of treatment. nPNA, AMC, MAMC, SGA, BMI, Kt/V, etc. are monitored only at 90 days. The total daily ultrafiltration volume of the patients (the experimental group also recorded the ultrafiltration volume of amino acid peritoneal fluid), and all adverse events (aes) and serious adverse events (SAEs) were recorded in detail.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Subjects were treated with 1 bag of amino acid (15) peritoneal dialysis solution (2L) once every morning, and then with conventional glucose peritoneal dialysate (lactate).
Subjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysate (lactate) (2L) once.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
ALB
To compare the difference in change from baseline in serum albumin (ALB) after 90 days of treatment of CAPD patients with amino acid (15) peritoneal dialysis solution versus conventional glucose peritoneal dialysis solution (lactate).
Time frame: After 90 days of treatment
serum transferrin
To compare the changes of serum transferrin in CAPD patients treated with amino acid (15) peritoneal dialysate and conventional glucose peritoneal dialysate (lactate) at 30 days, 60 days and 90 days compared with baseline.
Time frame: After 30, 60, and 90 days of treatment
arm muscle circumference (AMC)
omparison of standardized upper arm muscle circumference (AMC) changes from baseline after fasting peritoneal dialysis fluid emptying between amino acid (15) peritoneal dialysis solution and conventional glucose peritoneal dialysis solution (lactate) in CAPD patients treated for 90 days.
Time frame: After 90 days of treatment
standardized protein nitrogen occurrence rate (nPNA)
To compare the change of standardized protein nitrogen occurrence rate (nPNA) in CAPD patients treated with amino acid (15) peritoneal dialysis solution and conventional glucose peritoneal dialysis solution (lactate) after 90 days from baseline.
Time frame: After 90 days of treatment
subjective comprehensive nutritional assessment (SGA)
To compare the change of subjective comprehensive nutritional assessment (SGA) in CAPD patients treated with amino acid (15) peritoneal dialysis solution and conventional glucose peritoneal dialysis solution (lactate) after 90 days from baseline.
Time frame: After 90 days of treatment
middle arm muscle circumference (MAMC)
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Enrollment
400
Peking University People&'s Hospital
Beijing, Beijing Municipality, China
RECRUITINGWuhan NO.1 Hospital
Wuhan, Hubei, China
RECRUITINGThe Third Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGWest China Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGThe Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
RECRUITINGGanzhou People's Hospital
Ganzhou, China
RECRUITINGAffiliated Hospital of Guangdong Medical University
Guangdong, China
RECRUITINGThe First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
RECRUITINGThe Affiliated Hospital of Southwest Medical University
Luzhou, China
RECRUITING...and 11 more locations
To compare the change of middle arm muscle circumference (MAMC) in CAPD patients treated with amino acid (15) peritoneal dialysis solution and conventional glucose peritoneal dialysis solution (lactate) after 90 days from baseline.
Time frame: After 90 days of treatment
serum prealbumin
To compare the changes of serum prealbumin in CAPD patients treated with amino acid (15) peritoneal dialysate and conventional glucose peritoneal dialysate (lactate) at 30 days, 60 days and 90 days compared with baseline.
Time frame: After 30, 60, and 90 days of treatment
serum albumin
To compare the changes of serum albumin in CAPD patients treated with amino acid (15) peritoneal dialysate and conventional glucose peritoneal dialysate (lactate) at 30 days, 60 days and 90 days compared with baseline.
Time frame: After 30, 60, and 90 days of treatment
body mass index (BMI)
To compare the change of standardized protein nitrogen occurrence rate (nPNA) in CAPD patients treated with amino acid (15) peritoneal dialysis solution and conventional glucose peritoneal dialysis solution (lactate) after 90 days from baseline.
Time frame: After 90 days of treatment