Phase 3 trial for continuous Kidney replacement therapy (CRRT) for acute Kidney failure subjects
Phase 3
- Conditions
- Health Condition 1: null- ACUTE RENAL FAILURE
- Registration Number
- CTRI/2015/01/005452
- Lead Sponsor
- FRESENIUS MEDICAL CARE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
•ARF subjects aged 18-60 years, 18 and 60 years inclusive. male or female;
•Subjects in intensive care unit suffering from acute renal failure and in need or CRRT
•Subjects with signed informed consent
Exclusion Criteria
•Subjects suffering from chronic renal insufficiency ( serum creatinine > 3mg/dL)
•Subjects with serum lactate level > 45mg/dl ( > 5 mmol/L);
•Subjects with Blood pH < 7.2
•Pregnant or breastfeeding woman;
•Subjects with malignant disease
•Subjects participating in another clinical trial
•Subjects without written informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Difference in HCO3- concentration between the 2 groups on treatment day 3Timepoint: â?¢day 3
- Secondary Outcome Measures
Name Time Method â?¢Difference between key electrolytes ( phosphorus, sodium, potassium, Magnesium, Chloride, Calcium) <br/ ><br>â?¢Acid base balance (pH) <br/ ><br>â?¢Blood glucose <br/ ><br>â?¢Recovery of renal function <br/ ><br>â?¢Duration of hospital stay <br/ ><br>â?¢Mortality rate <br/ ><br>Timepoint: day 3