Acute Respiratory Distress Syndrome After Cardiac Surgery Under Cardiopulmonary Bypass Clinical Trial
Official title:
Transpulmonary Gradient of Inflammation Biomarkers and Pulmonary Vascular Resistance in Acute Respiratory Failure After Cardiac Surgery Under Cardiopulmonary Bypass
| NCT number | NCT01723930 |
| Other study ID # | 5328 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | N/A |
| First received | November 6, 2012 |
| Last updated | November 7, 2012 |
Get a better understanding of the pathophysiological processes of acute respiratory failure
following cardiopulmonary bypass to initiate timely therapies targeted on a cell line.
Demonstrate that there is a relationship between increased transpulmonary gradients of
inflammation biomarkers (sRAGE, sICAM-1, SPB, PAI-1, ROS) and pulmonary vascular resistance
on the one hand and alveolo-capillary gas exchange on the other hand after cardiac surgery
under cardiopulmonary bypass.
| Status | Not yet recruiting |
| Enrollment | 30 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patient man or woman > 18 y.o. - Patient has signed informed consent prior to the study - Patient affiliated to a social security administration - Patient operated on for cardiac surgery at the University Hospital of Strasbourg. - Patient at high risk for postoperative respiratory failure defined by a SLIP score (Kor et al.) = 22 Kor: - High-risk cardiac intervention under cardiopulmonary bypass (19 pts) - COPD (10 pts) - Diabetes (6 pts) - gastroesophageal reflux (7 pts) - Alcohol abuse (11 pts) - Scheduled use of a pulmonary artery catheter and a left atrial catheter Exclusion Criteria: - Inability to obtain informed consent from the patient and / or unable to give informed patient information (difficulty understanding ...) - Urgent surgery (<24h) - Acute heart failure - Patient ventilated preoperatively - Allergy to Latex - Persons deprived of liberty or under judicial protection - Patient placed under guardianship - Pregnancy - Breastfeeding |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital | Strasbourg | Alsace |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | transpulmonary gradients of inflammation biomarkers (sRAGE, sICAM-1, SPB, PAI-1, ROS) and pulmonary vascular resistance | Demonstrate that there is a relationship between increased transpulmonary gradients of inflammation biomarkers (sRAGE, sICAM-1, SPB, PAI-1, ROS) and pulmonary vascular resistance on the one hand and alveolo-capillary gas exchange on the other hand after cardiac surgery under cardiopulmonary bypass. | during the surgery | No |