Contact information
Type
Scientific
Primary contact
Prof Claudia Spies
ORCID ID
Contact details
Dept. of Anesthesiology and Intensive Care Medicine
Charite-University Hospital Berlin
Schumannstr. 20-21
Berlin
10098
Germany
+49 (0)3045 053 1012
claudia.spies@charite.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
krit hematocrit study
Study hypothesis
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
Ethics approval received from the local medical ethics committee
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
Coronary artery disease requiring surgical revascularisation
Intervention
Hemodilution during cardiopulmonary bypass achieving a hematocrit of 20% versus 25%.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/02/2004
Overall trial end date
31/01/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Coronary artery disease patients to about to undergo coronary artery bypass graft surgery.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Ejection fraction less than 40%
2. Chronic Obstructive Pulmonary Disease (COPD)
3. Renal insufficiency
4. Peripheral artery disease
5. Hepatic dysfunction
Recruitment start date
01/02/2004
Recruitment end date
31/01/2005
Locations
Countries of recruitment
Germany
Trial participating centre
Dept. of Anesthesiology and Intensive Care Medicine
Berlin
10098
Germany
Sponsor information
Organisation
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Sponsor details
Department of Anesthesiology and Intensive Care Medicine
Schumannstr. 20-21
Berlin
10098
Germany
+49 (0)3045 053 1012
anaesth@charite.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany) - institutional funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16606474
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19747406
Publication citations
-
Results
von Heymann C, Sander M, Foer A, Heinemann A, Spiess B, Braun J, Krämer M, Grosse J, Dohmen P, Dushe S, Halle J, Konertz WF, Wernecke KD, Spies C, The impact of an hematocrit of 20% during normothermic cardiopulmonary bypass for elective low risk coronary artery bypass graft surgery on oxygen delivery and clinical outcome--a randomized controlled study [ISRCTN35655335]., Crit Care, 2006, 10, 2, R58, doi: 10.1186/cc4891.
-
Results
Sander M, Spies CD, Berger K, Schröder T, Grubitzsch H, Wernecke KD, von Heymann C, Perioperative indocyanine green clearance is predictive for prolonged intensive care unit stay after coronary artery bypass grafting--an observational study., Crit Care, 2009, 13, 5, R149, doi: 10.1186/cc8045.