Condition category
Urological and Genital Diseases
Date applied
13/02/2008
Date assigned
13/03/2008
Last edited
14/03/2008
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 Beng-Åke Henriksson

ORCID ID

Contact details

Sahlgrenska University Hospital
Department of Intensive Care (CIVA)
Gothenburg
SE- 413 45
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1446

Study information

Scientific title

Acronym

Study hypothesis

Reduction of heparin dose in acute renal failure treated with hemodiafiltration.

Ethics approval

Local research ethics committee, Göteborg, Sweden. Date of approval: 17/12/2007 (Dnr. 576-07)

Study design

Monocentric, open, randomised and controlled study with two parallel groups.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (in Swedish only)

Condition

Acute renal failure/ fluid overload

Intervention

The same dialysis membrane, AN69ST, will be used for both the intervention and control treatment. Two different heparinization strategies will be compared:

Control group (usual heparin doses): Bolus at start (between 1,000 IU - 2,500 IU) + usual infusion dose (10 IU/kg/h)
Intervention group (Reduction of heparin dose): No bolus at start + infusion decreased by 50% (5 IU/kg/h)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Filter lifespan, defined as the time period between patient's connection and filter disconnection due to filter clotting.

Secondary outcome measures

Adverse events, monitored for up to 24 days of treatment

Overall trial start date

12/02/2008

Overall trial end date

01/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients requiring continuous renal replacement therapies (CRRT)
2. Aged 18 and over
3. Patients weighing 30-120 kg
4. Patients having signed a written consent to participate in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

44

Participant exclusion criteria

1. History of heparin antibodies or heparin-induces thrombocytopenia
2. Known hypertensive to any dialysis membrane
3. Current enrolment in another trial which could impact the successful completion of this study
4. Patients under guardianship
5. Patient anticipated to require transportation outside the unit for diagnostic or therapeutic procedures in the coming first week .These patients can eventually be included in a later more stable phase
6. Unconscious patients for whom no relative or person of trust can give consent to treatment. In the absence of any relative or person of trust, the patient in question cannot be included in the study
7. Patient requiring anticoagulation for other indications e.g., valvular surgery or extracorporeal ventricular assist devices
8. Patients with active bleeding who does not require heparinization

Recruitment start date

12/02/2008

Recruitment end date

01/01/2010

Locations

Countries of recruitment

Sweden

Trial participating centre

Sahlgrenska University Hospital
Gothenburg
SE- 413 45
Sweden

Sponsor information

Organisation

Gambro Lundia AB (Sweden)

Sponsor details

Clinical Trial Function
Clinical Affairs
P.O. Box 10101
Lund
SE -220 10
Sweden

Sponsor type

Industry

Website

http://www.gambro.com/int

Funders

Funder type

Industry

Funder name

Gambro Lundia AB (Sweden)

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