Trial to investigate the impact of haemodialysis before transplant surgery on early kidney allograft function
| ISRCTN | ISRCTN07061584 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07061584 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/04/2009
- Registration date
- 20/04/2009
- Last edited
- 20/04/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Georg Böhmig
Scientific
Scientific
Division of Nephrology and Dialysis
Department of Medicine III
Medical University of Vienna
Währinger Gürtel 18-20
Vienna
A-1090
Austria
| Phone | +43 (0)1 40400 4363 |
|---|---|
| georg.boehmig@meduniwien.ac.at |
Study information
| Study design | Open-label single centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Randomised controlled trial evaluating the effect of haemodialysis applied before transplant surgery on early renal allograft function |
| Study objectives | 1. Due to the pro-inflammatory effects of dialyser exposure pre-transplant haemodialysis adversely affects the evolution of early renal allograft function 2. Owing to its anti-inflammatory effects regional dialysis citrate anticoagulation improves early graft function |
| Ethics approval(s) | Ethics Committee of the Medical University of Vienna approved on the 30th June 2003 (ref: 151/2003) |
| Health condition(s) or problem(s) studied | Kidney allograft function |
| Intervention | Based on pre-transplant levels of serum potassium (a concentration greater than 5.0 mEq/L is regarded as a requirement for pre-operative dialysis) patients are randomly assigned to one of two separate two-group parallel randomised controlled trials: 1. Patients presenting with a potassium less than or equal to 5.0 mEq/L are randomised to undergo haemodialysis versus no dialysis 2. Patients with a potassium greater than 5.0 mEq/L are randomised to receive anticoagulation during dialysis with heparin versus citrate Patients assigned to pre-transplant haemodialysis receive treatment with a full-synthetic low-flux polysulfone membrane and a bicarbonate-buffered dialysate. Blood flow is adjusted to 200 to 400 ml/min and dialysate flow to 500 ml/min. Patients are dialysed for 3.0 hours without ultrafiltration. Patients randomised to heparin anticoagulation receive an initial bolus of 1000 U of heparin followed by continuous infusion of 1000 U per hour. Patients allocated to citrate anticoagulation receive trisodium citrate at a rate of 25 - 50 mmol/h via the arterial line. Calcium is supplemented using a continuous infusion of half-molar calcium chloride solution into the venous return (initial starting dose 10 mmol/h). For citrate anticoagulation, a calcium-free dialysate is used. To keep systemic free calcium levels constant within +/- 10% of the baseline value calcium infusion rates are adjusted according to the results of regular monitoring of blood ionized calcium. |
| Intervention type | Other |
| Primary outcome measure | 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 | 1. eGFR according to the Mayo Clinic equation at day 5 2. Serum creatinine level at day 5 3. Delayed graft function (need for dialysis within the first post-transplant week) 4. Slow graft function (definition: serum creatinine greater than 3 mg/dL on post-operative day 5 without requiring dialysis) 5. Acute biopsy-proven cell-mediated allograft rejection within the first three months 6. Acute C4d-positive graft dysfunction within the first three months 7. One-year actuarial death-censored graft survival |
| Overall study start date | 02/07/2003 |
| Completion date | 18/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 220 |
| Key inclusion criteria | Adult (aged 18 years and over) male or female end-stage renal disease patients on maintenance haemodialysis anticipating deceased donor kidney allotransplantation. |
| Key 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 |
| Date of first enrolment | 02/07/2003 |
| Date of final enrolment | 18/09/2008 |
Locations
Countries of recruitment
- Austria
Study participating centre
Division of Nephrology and Dialysis
Vienna
A-1090
Austria
A-1090
Austria
Sponsor information
Medical University of Vienna (Austria)
University/education
University/education
Department of Medicine III
Währinger Gürtel 18-20
Vienna
A-1090
Austria
| Phone | +43 (0)1 40400 4391 |
|---|---|
| walter.hoerl@meduniwien.ac.at | |
| Website | http://www.meduniwien.ac.at |
"ROR" |
https://ror.org/05n3x4p02 |
Funders
Funder type
University/education
Medical University of Vienna (Austria)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
