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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Subjects were treated with 1 bag of amino acid (15) peritoneal dialysate (2L) once every morning, and then with conventional glucose peritoneal dialysate (lactate). |
|
| control group | Active Comparator | Subjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysate (lactate) (2L) once. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amino acid (15) peritoneal dialysis solution | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | After 90 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 30, 60, and 90 days of treatment |
| arm muscle circumference (AMC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Deng | Contact | 86 136 9940 1416 | dq0416@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | 230022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31464251 | Background | My Thuc LT, Dung NQ, Ha VN, Tam ND, Hang Nga NT. Actual diet and nutritional deficiencies status in children on peritoneal dialysis at the Vietnam National Hospital of Pediatrics. Saudi J Kidney Dis Transpl. 2019 Jul-Aug;30(4):924-931. doi: 10.4103/1319-2442.265470. | |
| 7783413 | Background | Kopple JD, Bernard D, Messana J, Swartz R, Bergstrom J, Lindholm B, Lim V, Brunori G, Leiserowitz M, Bier DM, et al. Treatment of malnourished CAPD patients with an amino acid based dialysate. Kidney Int. 1995 Apr;47(4):1148-57. doi: 10.1038/ki.1995.164. |
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| glucose peritoneal dialysis solution | Drug | Subjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysate (lactate) (2L) once. |
|
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. |
| 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. | 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. | After 90 days of treatment |
| middle arm muscle circumference (MAMC) | 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. | 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. | 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. | 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. | After 90 days of treatment |
| Peking University People&'s Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| Wuhan NO.1 Hospital | Recruiting | Wuhan | Hubei | China |
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| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410000 | China |
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| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610000 | China |
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| The Second Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | China |
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| Ganzhou People's Hospital | Recruiting | Ganzhou | China |
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| Affiliated Hospital of Guangdong Medical University | Recruiting | Guangdong | China |
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| The First Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | China |
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| The Affiliated Hospital of Southwest Medical University | Recruiting | Luzhou | China |
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| Meishan Hospital, West China Hospital, Sichuan University (Meishan People's Hospital) | Recruiting | Meishan | China |
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| Jiangsu Province Hosipital | Recruiting | Nanjing | China |
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| The Affiliated Hospital of Nanjing university Medical School | Recruiting | Nanjing | China |
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| The First Affiliated Hospital of Guangxi Medical University | Recruiting | Nanning | China |
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| Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University | Recruiting | Shanghai | China |
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| General Hospital of Northern Theater Command | Recruiting | Shenyang | China |
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| The Central Hospital of Wuhan | Recruiting | Wuhan | China |
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| Zhongshan Hospital Xiamen University | Recruiting | Xiamen | China |
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| The First Affiliated Hospital of Xinxiang Medical College | Recruiting | Xinxiang | China |
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| The Second People's Hospital of Yibin City | Recruiting | Yibin | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | China |
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| 19602603 | Background | Tjiong HL, Swart R, van den Berg JW, Fieren MW. Amino Acid-based peritoneal dialysis solutions for malnutrition: new perspectives. Perit Dial Int. 2009 Jul-Aug;29(4):384-93. |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000596 | Amino Acids |
| D015314 | Dialysis Solutions |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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