Transpulmonary Gradient After Cardiac Surgery Under Cardi... | NCT01723930 | Trialant
NCT01723930
Sponsor
University Hospital, Strasbourg, France
Status
Unknown status
Last Update Posted
Nov 8, 2012Estimated
Enrollment
30
Phase
Not provided
Conditions
Acute Respiratory Distress Syndrome After Cardiac Surgery Under Cardiopulmonary Bypass
Interventions
Not provided
Countries
France
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01723930
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
5328
Secondary IDs
Not provided
Brief Title
Transpulmonary Gradient After Cardiac Surgery Under Cardiopulmonary Bypass
Official Title
Transpulmonary Gradient of Inflammation Biomarkers and Pulmonary Vascular Resistance in Acute Respiratory Failure After Cardiac Surgery Under Cardiopulmonary Bypass
Acronym
Not provided
Organization
University Hospital, Strasbourg, FranceOTHER
Status Module
Record Verification Date
Nov 2012
Overall Recruitment Status or Expanded Access Status
Unknown status
Last Known Status
Not yet recruiting
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Not provided
Primary Completion Date
Not provided
Completion Date
Not provided
First Submitted Date
Nov 6, 2012
First Submission Date that Met QC Criteria
Nov 7, 2012
First Posted Date
Nov 8, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 7, 2012
Last Update Posted Date
Nov 8, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
University Hospital, Strasbourg, FranceOTHER
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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.
Detailed Description
Not provided
Conditions Module
Conditions
Acute Respiratory Distress Syndrome After Cardiac Surgery Under Cardiopulmonary Bypass
Keywords
Not provided
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
30
Arms/Interventions Module
No data available
No data is available for this block.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Recruitment concerns only patients with high risk of postoperative respiratory failure (SLIP score > 22).