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 |
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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
Scientific
Dept. of Anesthesiology and Intensive Care Medicine
Charite-University Hospital Berlin
Schumannstr. 20-21
Berlin
10098
Germany
Phone | +49 (0)3045 053 1012 |
---|---|
claudia.spies@charite.de |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Screening |
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 | Oxygen delivery and oxygen consumption. |
Secondary outcome measures | 1. Myocardial infarction 2. Renal insufficiency measured as creatinine and urine volume 3. Neurological deficits displayed as agitated arousal reactions and stroke |
Overall study start date | 01/02/2004 |
Completion date | 31/01/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- Germany
Study participating centre
Dept. of Anesthesiology and Intensive Care Medicine
Berlin
10098
Germany
10098
Germany
Sponsor information
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Hospital/treatment centre
Hospital/treatment centre
Department of Anesthesiology and Intensive Care Medicine
Schumannstr. 20-21
Berlin
10098
Germany
Phone | +49 (0)3045 053 1012 |
---|---|
anaesth@charite.de | |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |