Renal Function Disorder
Conditions
Keywords
CAPD, Diuretics, Residual Renal Function, furosemide
Brief summary
A prospective, randomized, open-label, stratified, controlled clinical trial to evaluate whether long term furosemide therapy (1 year) would preserve urine volume and/or residual renal function (RRF) and improve fluid state in continuous ambulatory peritoneal dialysis (CAPD) patients.
Detailed description
There are 3 phases in this study. Phase 1 is screening phase. Each subject will be evaluated to determine if he/she is eligible for the study. Phase 2 is the intervention phage. Patients are divided arbitrarily into two groups according to baseline RRF (residual glomerular filtration rate \[rGFR\] \<5or \> 5 ml/min), then randomly received 12 months treatment with the study drugs( furosemide 120mg daily, 60mg daily, or no diuretic). Phase 3 is following-up phase, which lasts 1 year. Dialytic prescription is adjusted independent of the study and is guided by clinical parameters and calculated clearances (target creatinine clearance 65L/week, urea clearance Kt/V \> 1.7 per week). Blood pressure is measured using an automated blood pressure device, and the target level is 135/85mmHg. The antihypertensive medication is introduced after the body weigh reduced into target level, and the ACEI and /or ARB selection is needed to the cross-sectional design. The hydration state is measured by bioelectrical impedance analysis (BIA).
Interventions
DRUGfurosemide
patients will take furosemide 60 or 120mg oral per day for 1 years .
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Willingness to sign an informed consent * Age:20\ 70 years, regardless of gender * All patients received CAPD more than 1 months; * Urine volume of 500ml/d or more; * No history of taking furosemide for at least 2 weeks .
Exclusion criteria
* Inability or unwillingness to sign the informed consent * Inability or unwillingness to meet the scheme demands raised by the investigators * Current acute infection such as peritonitis ; * Severe diarrhea or vomiting within the preceding 1 month * Acute Cardiac failure * Myocardial infarction within the preceding 6 months; * Hypertensive encephalopathy or cerebrovascular accident; * Accident within the preceding 6 months; * Any condition, such as alcohol or drug abuse, chronic liver disease, malignant disease, or psychiatric disorder; * Allergy or intolerance to furosemide . * Current or recent (within 2 weeks) exposure to any other investigational drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Residual renal function and urine volume | Every 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Dialysis adequacy, fluid status(BIA parameters: Total body water, ECW/TBW), serum Cystatin C, blood pressure, hospitalization, death from any cause,cardiovascular events, any adverse drug effects | Every 3 months |
Countries
China
Outcome results
None listed