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
Secondary identifying numbers N/A
Submission date
11/01/2006
Registration date
19/01/2006
Last edited
29/03/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeScreening
Scientific title
Study acronymkrit hematocrit study
Study objectivesTo 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) studiedCoronary artery disease requiring surgical revascularisation
InterventionHemodilution during cardiopulmonary bypass achieving a hematocrit of 20% versus 25%.
Intervention typeOther
Primary outcome measureOxygen delivery and oxygen consumption.
Secondary outcome measures1. Myocardial infarction
2. Renal insufficiency measured as creatinine and urine volume
3. Neurological deficits displayed as agitated arousal reactions and stroke
Overall study start date01/02/2004
Completion date31/01/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants60
Key inclusion criteriaCoronary artery disease patients to about to undergo coronary artery bypass graft surgery.
Key exclusion criteria1. Ejection fraction less than 40%
2. Chronic Obstructive Pulmonary Disease (COPD)
3. Renal insufficiency
4. Peripheral artery disease
5. Hepatic dysfunction
Date of first enrolment01/02/2004
Date of final enrolment31/01/2005

Locations

Countries of recruitment

  • Germany

Study participating centre

Dept. of Anesthesiology and Intensive Care Medicine
Berlin
10098
Germany

Sponsor information

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Hospital/treatment centre

Department of Anesthesiology and Intensive Care Medicine
Schumannstr. 20-21
Berlin
10098
Germany

Phone +49 (0)3045 053 1012
Email anaesth@charite.de
ROR logo "ROR" https://ror.org/001w7jn25

Funders

Funder type

Hospital/treatment centre

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany) - institutional funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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