The influence of surgical interventions with and without cardiopulmonary bypass on Ca2+ signalling in alveolar macrophages

ISRCTN	ISRCTN94348100
DOI	https://doi.org/10.1186/ISRCTN94348100
Secondary identifying numbers	VO 741/6-1

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Thomas Volk
Scientific

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

Study design	Prospective cohort trial with two control groups.
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	Cacao
Study objectives	A direct G-protein-stimulated ratiometric calcium ion (Ca2+) signal in alveolar macrophages decreases after surgical interventions with cardiopulmonary bypass.
Ethics approval(s)	Ethics approval received from the Charite - Universitaetsmedizin Berlin ethikkommission on the 8th March 2003 (ref: EA1/146/06).
Health condition(s) or problem(s) studied	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
Primary outcome measure	Calcium signal intensity, measured immediately preoperatively and after the surgical procedure.
Secondary outcome measures	Postoperative pulmonary infection, measured on day of discharge.
Overall study start date	01/06/2007
Completion date	31/05/2010

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	60
Key inclusion criteria	1. Elective coronary bypass graft surgery 2. Elective panendoscopy 3. Elective thoracic surgery
Key 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
Date of first enrolment	01/06/2007
Date of final enrolment	31/05/2010

Klinik fur Anaesthesiologie und Operative Intensivmedizin

Berlin
10117
Germany

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

Chariteplatz 1
Berlin
10117
Germany

Website	http://www.charite.de
"ROR"	https://ror.org/001w7jn25

University/education

Humboldt University of Berlin (Germany)

No information available

Intention to publish date
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