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Trial to investigate the impact of haemodialysis before transplant surgery on early kidney allograft functio

Completed
Conditions
Kidney allograft function
Urological and Genital Diseases
Disorders 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
Inclusion Criteria

Adult (aged 18 years and over) male or female end-stage renal disease patients on maintenance haemodialysis anticipating deceased donor kidney allotransplantation.

Exclusion Criteria

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
NameTimeMethod
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
NameTimeMethod
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
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