Trial to investigate the impact of haemodialysis before transplant surgery on early kidney allograft functio
- Conditions
- Kidney allograft functionUrological and Genital DiseasesDisorders resulting from impaired renal tubular function
- Registration Number
- ISRCTN07061584
- Lead Sponsor
- Medical University of Vienna (Austria)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 220
Adult (aged 18 years and over) male or female end-stage renal disease patients on maintenance haemodialysis anticipating deceased donor kidney allotransplantation.
1. Aged less than 18 years
2. Pre-emptive kidney transplantation
3. Non-heart-beating donor transplantation
4. Combined organ transplantation
5. Continuous ambulatory peritoneal dialysis as maintenance renal replacement therapy
6. Symptomatic fluid overload necessitating pre-operative ultrafiltration
7. Presensitised patients subjected to peri-transplant immunoadsorption for desensitisation
8. Patients subjected to haemodialysis less than 16 hours before randomisation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Estimated glomerular filtration rate (eGFR) at day 5 post-transplantation calculated according to the reexpressed Modification of Diet in Renal Disease (MDRD) study equation.
- Secondary Outcome Measures
Name Time Method 1. eGFR according to the Mayo Clinic equation at day 5<br>2. Serum creatinine level at day 5<br>3. Delayed graft function (need for dialysis within the first post-transplant week)<br>4. Slow graft function (definition: serum creatinine greater than 3 mg/dL on post-operative day 5 without requiring dialysis)<br>5. Acute biopsy-proven cell-mediated allograft rejection within the first three months<br>6. Acute C4d-positive graft dysfunction within the first three months<br>7. One-year actuarial death-censored graft survival