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

ISRCTN	ISRCTN35655335
DOI	https://doi.org/10.1186/ISRCTN35655335
Protocol serial number	N/A
Sponsor	Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Funder	Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany) - institutional funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Claudia Spies
Scientific

Dept. of Anesthesiology and Intensive Care Medicine
Charite-University Hospital Berlin
Schumannstr. 20-21
Berlin
10098
Germany

Phone	+49 (0)3045 053 1012
Email	claudia.spies@charite.de

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	krit hematocrit study
Study objectives	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.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Coronary artery disease requiring surgical revascularisation
Intervention	Hemodilution during cardiopulmonary bypass achieving a hematocrit of 20% versus 25%.
Intervention type	Other
Primary outcome measure(s)	Oxygen delivery and oxygen consumption.
Key secondary outcome measure(s)	1. Myocardial infarction 2. Renal insufficiency measured as creatinine and urine volume 3. Neurological deficits displayed as agitated arousal reactions and stroke
Completion date	31/01/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	60
Key inclusion criteria	Coronary artery disease patients to about to undergo coronary artery bypass graft surgery.
Key exclusion criteria	1. Ejection fraction less than 40% 2. Chronic Obstructive Pulmonary Disease (COPD) 3. Renal insufficiency 4. Peripheral artery disease 5. Hepatic dysfunction
Date of first enrolment	01/02/2004
Date of final enrolment	31/01/2005

Dept. of Anesthesiology and Intensive Care Medicine

Berlin
10098
Germany

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2006		Yes	No
Results article	results	01/07/2009		Yes	No