Condition category
Urological and Genital Diseases
Date applied
03/04/2009
Date assigned
20/04/2009
Last edited
20/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.meduniwien.ac.at

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes