Contact information
Type
Scientific
Primary contact
Dr Georg Böhmig
ORCID ID
Contact details
Division of Nephrology and Dialysis
Department of Medicine III
Medical University of Vienna
Währinger Gürtel 18-20
Vienna
A-1090
Austria
+43 (0)1 40400 4363
georg.boehmig@meduniwien.ac.at
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Randomised controlled trial evaluating the effect of haemodialysis applied before transplant surgery on early renal allograft function
Acronym
Study hypothesis
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
Ethics Committee of the Medical University of Vienna approved on the 30th June 2003 (ref: 151/2003)
Study design
Open-label single centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
02/07/2003
Overall trial end date
18/09/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adult (aged 18 years and over) male or female end-stage renal disease patients on maintenance haemodialysis anticipating deceased donor kidney allotransplantation.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
220
Participant 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
Recruitment start date
02/07/2003
Recruitment end date
18/09/2008
Locations
Countries of recruitment
Austria
Trial participating centre
Division of Nephrology and Dialysis
Vienna
A-1090
Austria
Sponsor information
Organisation
Medical University of Vienna (Austria)
Sponsor details
Department of Medicine III
Währinger Gürtel 18-20
Vienna
A-1090
Austria
+43 (0)1 40400 4391
walter.hoerl@meduniwien.ac.at
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Medical University of Vienna (Austria)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list