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ISRCTN
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ISRCTN35655335
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ClinicalTrials.gov identifier
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Public title
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The impact of a hematocrit of 20% during normothermic cardiopulmonary bypass for elective coronary artery bypass graft surgery on oxygen delivery and clinical outcome: a randomised controlled study
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Scientific title
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Acronym
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krit hematocrit study
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Serial number at source
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N/A
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Study hypothesis
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To evaluate whether a hematocrit of 20% versus 25% during normothermic cardiopulmonary bypass for Coronary Artery Bypass Graft (CABG) surgery influences oxygen delivery and oxygen consumption.
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Lay summary
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Ethics approval
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Ethics approval received from the local medical ethics committee
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Coronary artery disease requiring surgical revascularisation
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Participants - inclusion criteria
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Coronary artery disease patients to about to undergo coronary artery bypass graft surgery.
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Participants - exclusion criteria
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1. Ejection fraction less than 40%
2. Chronic Obstructive Pulmonary Disease (COPD)
3. Renal insufficiency
4. Peripheral artery disease
5. Hepatic dysfunction
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Anticipated start date
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01/02/2004
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Anticipated end date
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31/01/2005
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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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60
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Interventions
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Hemodilution during cardiopulmonary bypass achieving a hematocrit of 20% versus 25%.
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Primary outcome measure(s)
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Oxygen delivery and oxygen consumption.
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Secondary outcome measure(s)
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1. Myocardial infarction
2. Renal insufficiency measured as creatinine and urine volume
3. Neurological deficits displayed as agitated arousal reactions and stroke
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Sources of funding
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Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany) - institutional funding
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Trial website
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Publications
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1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16606474
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19747406
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Contact name
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Prof
Claudia
Spies
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Address
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Dept. of Anesthesiology and Intensive Care Medicine
Charite-University Hospital Berlin
Schumannstr. 20-21
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City/town
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Berlin
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Zip/Postcode
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10098
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Country
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Germany
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Tel
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+49 (0)3045 053 1012
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Fax
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+49 (0)3045 053 1911
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Email
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claudia.spies@charite.de
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Sponsor
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Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
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Address
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Department of Anesthesiology and Intensive Care Medicine
Schumannstr. 20-21
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City/town
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Berlin
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Zip/Postcode
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10098
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Country
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Germany
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Tel
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+49 (0)3045 053 1012
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Fax
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+49 (0)3045 053 1911
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Email
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anaesth@charite.de
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Date applied
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11/01/2006
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Last edited
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29/03/2010
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Date ISRCTN assigned
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19/01/2006
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