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 |
| Protocol serial number | VO 741/6-1 |
| Sponsor | Charite - University Medicine Berlin (Charite - Universitaetsmedizin Berlin) (Germany) |
| Funder | Humboldt University of Berlin (Germany) |
- Submission date
- 26/09/2007
- Registration date
- 06/11/2007
- Last edited
- 06/11/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
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
Contact information
Prof Thomas Volk
Scientific
Scientific
Klinik fur Anaesthesiologie und Operative Intensivmedizin
Charite Campus Mitte und Campus Virchow Klinikum
Chariteplatz 1
Berlin
10117
Germany
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective cohort trial with two control groups. |
| Secondary study design | Cohort study |
| 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(s) |
Calcium signal intensity, measured immediately preoperatively and after the surgical procedure. |
| Key secondary outcome measure(s) |
Postoperative pulmonary infection, measured on day of discharge. |
| Completion date | 31/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Germany
Study participating centre
Klinik fur Anaesthesiologie und Operative Intensivmedizin
Berlin
10117
Germany
10117
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
