Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
29/08/2012
Prospective/Retrospective
Prospectively 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

Mr TJJ Jones

ORCID ID

Contact details

Cardiac Services
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265006268

Study information

Scientific title

Acronym

Study hypothesis

Derangements of renal haemodynamics occur during Cardio-Pulmonary Bypass (CPB), but the degree of derangement can be ameliorated by appropriate pharmacological intervention.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Acute renal failure during cardiopulmonary bypass surgery.

Intervention

1100 patients undergoing cardiac surgery with the use of CPB will be allocated randomly to one of four groups. The administration of the allocated intervention will be as follows:

1. Group 1: dopamine 3 mg/kg/min intravenous infusion from induction for 24 hours
2. Group 2: frusemide 2 mg/h intravenous infusion from induction for 24 hours
3. Group 3: mannitol 0.5 g/kg in the CPB circuit
4. Group 4: control - no intervention

Anaesthetic, cardiopulmonary bypass and postoperative regimes will be standardised to current departmental protocols. Serum creatinine will be measured pre- and post-operatively at two and five days. A 5 ml urine sample will be taken from the patient's catheter bag at induction of anaesthesia and immediately at the end of the operation. This will be aliquoted into two polypropylene tubes and frozen to -20°C prior to analysis. Strict records will be kept of additional dopamine, frusemide and other diuretic requirement during the study period.

Intervention type

Drug

Phase

Not Specified

Drug names

Dopamine, frusemide and mannitol

Primary outcome measures

1. Oliguria, defined as a urine output of less than 0.5 ml/kg/h for two consecutive hours, or less than 400 ml urine over any 24 hour period postoperatively. In addition, the need for frusemide or dopamine to maintain adequate urine output
2. Creatinine change, an increase of 50% from the baseline creatinine (i.e. a 33% reduction in Glomerular Filtration Rate [GFR])
3. Glomerular permeability (monitored by urinary albumin excretion)
4. Renal replacement therapy
5. Death

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2006

Overall trial end date

01/01/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

1100

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2006

Recruitment end date

01/01/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiac Services
Birmingham
B15 2TH
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

University Hospital Birmingham NHS Trust (UK)

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