Condition category
Circulatory System
Date applied
11/01/2006
Date assigned
19/01/2006
Last edited
29/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

  2. 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.

Additional files

Editorial Notes