The Effect of Incremental Continous Ambulatory Peritoneal Dialysis on the Preservation of Residual Kidney Function and Clinical Outcomes: A Randomized Controlled Trial

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
Tidak ada
No Registry
INA-R8NGMEW
Tanggal Input Registry : 02-06-2021

01-07-2021
1. The changes of Residual Kidney Function (RKF) in both groups at day-30, 60, and 90. 2. The quality of life (QoL) of CAPD patients at day-90.
1. The incidence of peritonitis in both groups at day-90. 2. The incidence of fluid overload in both groups at day-30, 60, and 90. 3. The changes in blood markers (Hemoglobin, calcium, phosphate, albumin, CRP) these two groups of intervention at day-30, 60, and 90. 4. The changes of blood glucose level in patients with diabetes mellitus at day-30, 60, and 90.
 
The Effect of Incremental Continous Ambulatory Peritoneal Dialysis on the Preservation of Residual Kidney Function and Clinical Outcomes: A Randomized Controlled Trial
The Effect of Incremental Continous Ambulatory Peritoneal Dialysis on the Preservation of Residual Kidney Function and Clinical Outcomes: A Randomized Controlled Trial
Eksperimental
CAPD patients will be screened according to the examination results of baseline eGFR and 24-hour urine volume. Patients with significant Residual Kidney Function will be assigned as potential subject in this study and screened based on the inclusion and exclusion criteria. The significant Residual Kidney Function is defined as if a patient has minimum urine volume of 400 ml/day and residual eGFR minimum of: - 6 mL/min/1.73 m2 for body weight 40-55 kg - 8 mL/min/1.73 m2 for body weight 55.1-73 kg - 9 mL/min/1.73 m2 for body weight 73.1-91 kg - 10 mL/min/1.73 m2 for body weight 91.1-109 kg Subjects who agree to join this study will undergo physical examination and laboratory tests (hemoglobin, ureum, creatinine, calcium, phosphate, albumin, serum iron, TIBC, ferritin, CRP, electrolyte, and peritoneal equilibration test) as baseline data; assigned as data at day-0. In addition, they will fill out the KDQOL-SFTM 1.3 questionnaire for baseline QoL data. They will be randomly assigned to intervention or control group in a 1:1 ratio using block randomization. Subjects in intervention group (Group A) will receive 1 cycle of Icodextrin with 8-12 hours dwell time at night and 2 cycles of Dianeal with dwell time 4-6 hours per day. Subjects in control group (Group B) will be receive 4 cycles of Dianeal per day with dwell time 4-6 hours each. Concentration of the glucose prescribed will be decided by the clinician based on volume status, urine production, and daily ultrafiltration. Subjects will be assessed in three months trial. The assessment for primary and secondary outcomes will be held at day-30, 60, and 90.
60
 

Inclusion Criteria:

1. Current or new CAPD patients 2. Aged above 18-year-old 3. Minimum urine volume of 400 ml/day, 4. Minimum residual eGFR as below: 6 mL/min/1.73 m2 for body weight 40-55 kg; 8 mL/min/1.73 m2 for body weight 55.1-73 kg ; 9 mL/min/1.73 m2 for body weight 73.1-91 kg; 10 mL/min/1.73 m2 for body weight 91.1-109 kg. 5. Agree to join the study and give the consent

Exclusion Criteria:

1. Patients who are receiving immunosuppressive drugs or had stopped immunosuppressive drugs less than 4 weeks before screening 2. Diagnosed with advanced malignancy, defined as malignancy that unlikely to be cured or controlled by treatment. The cancer may have spread to lymph nodes, nearby tissue, or distant part of the body 3. Have history or currently having of abdominal hernia or , cardiac failure, 4. Had stated as having a life expectancy of
 
KET-505/UN2.F1/ETIK/PPM.00.02/2021
21-05-0475
dr. Ni Made Hustrini, SpPD-KGH; dr. Anandhara Indriani, SpPD; dr. Dimas Septiar, SpPD