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

ISRCTN	ISRCTN07061584
DOI	https://doi.org/10.1186/ISRCTN07061584
Protocol serial number	N/A
Sponsor	Medical University of Vienna (Austria)
Funder	Medical University of Vienna (Austria)

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

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
Email	georg.boehmig@meduniwien.ac.at

Study information

Primary study design	Interventional
Study design	Open-label single centre randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Estimated glomerular filtration rate (eGFR) at day 5 post-transplantation calculated according to the reexpressed Modification of Diet in Renal Disease (MDRD) study equation.
Key secondary outcome measure(s)	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
Completion date	18/09/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan