Protection against acute renal failure following cardiac surgery

ISRCTN	ISRCTN98672577
DOI	https://doi.org/10.1186/ISRCTN98672577
Protocol serial number	N0265006268
Sponsor	Department of Health (UK)
Funder	University Hospital Birmingham NHS Trust (UK)

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 29/08/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

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

Mr TJJ Jones
Scientific

Cardiac Services
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Derangements of renal haemodynamics occur during Cardio-Pulmonary Bypass (CPB), but the degree of derangement can be ameliorated by appropriate pharmacological intervention.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Dopamine, frusemide and mannitol
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2009

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	1100
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2006
Date of final enrolment	01/01/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Cardiac Services

Birmingham
B15 2TH
United Kingdom

Results and Publications

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