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ISRCTN
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ISRCTN98672577
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ClinicalTrials.gov identifier
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Public title
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Protection against acute renal failure following cardiac surgery
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0265006268
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Study hypothesis
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Derangements of renal haemodynamics occur during Cardio-Pulmonary Bypass (CPB), but the degree of derangement can be ameliorated by appropriate pharmacological intervention.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Acute renal failure during cardiopulmonary bypass surgery.
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Participants - inclusion criteria
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Not provided at time of registration
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2006
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Anticipated end date
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01/01/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1100
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Interventions
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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.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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University Hospital Birmingham NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Mr
TJJ
Jones
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Address
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Cardiac Services
Queen Elizabeth Hospital
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City/town
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Birmingham
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Zip/Postcode
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B15 2TH
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Country
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United Kingdom
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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18/06/2008
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Date ISRCTN assigned
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12/09/2003
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