Condition category
Respiratory
Date applied
26/09/2007
Date assigned
06/11/2007
Last edited
06/11/2007
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 Thomas Volk

ORCID ID

Contact details

Klinik fur Anaesthesiologie und Operative Intensivmedizin
Charite Campus Mitte und Campus Virchow Klinikum
Chariteplatz 1
Berlin
10117
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

VO 741/6-1

Study information

Scientific title

Acronym

Cacao

Study hypothesis

A direct G-protein-stimulated ratiometric calcium ion (Ca2+) signal in alveolar macrophages decreases after surgical interventions with cardiopulmonary bypass.

Ethics approval

Ethics approval received from the Charite - Universitaetsmedizin Berlin ethikkommission on the 8th March 2003 (ref: EA1/146/06).

Study design

Prospective cohort trial with two control groups.

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Pulmonary dysfunction after surgery

Intervention

Bronchoscopy with Broncho-Alveolar Lavage (BAL) and blood samples before and after surgery. Routine bronchoscopy is used as recommended in a guideline. Duration of treatment is defined by the length of hospital stay. Duration of the diagnostic procedure is approximately 10 minutes. Total duration of follow up also is defined by the length of the hospital stay.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Calcium signal intensity, measured immediately preoperatively and after the surgical procedure.

Secondary outcome measures

Postoperative pulmonary infection, measured on day of discharge.

Overall trial start date

01/06/2007

Overall trial end date

31/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Elective coronary bypass graft surgery
2. Elective panendoscopy
3. Elective thoracic surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Aged less than 18 years
2. Relevant pulmonary diseases with oxygenation deficit
3. Liver disease stage greater than Child B
4. Human Immunodeficiency Virus (HIV)-infection
5. Corticosteroid therapy
6. Organ transplantation
7. Perioperative infection
8. Chronic inflammatory disease
9. Pregnancy

Recruitment start date

01/06/2007

Recruitment end date

31/05/2010

Locations

Countries of recruitment

Germany

Trial participating centre

Klinik fur Anaesthesiologie und Operative Intensivmedizin
Berlin
10117
Germany

Sponsor information

Organisation

Charite - University Medicine Berlin (Charite - Universitaetsmedizin Berlin) (Germany)

Sponsor details

Chariteplatz 1
Berlin
10117
Germany

Sponsor type

University/education

Website

http://www.charite.de

Funders

Funder type

University/education

Funder name

Humboldt University of Berlin (Germany)

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

Publication citations

Additional files

Editorial Notes