Transpulmonary Gradient After Cardiac Surgery Under Cardiopulmonary Bypass

Transpulmonary Gradient of Inflammation Biomarkers and Pulmonary Vascular Resistance in Acute Respiratory Failure After Cardiac Surgery Under Cardiopulmonary Bypass

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.

Study Overview

• Status: Unknown
• Conditions: Acute Respiratory Distress Syndrome After Cardiac Surgery Under Cardiopulmonary Bypass

• Study Type: Observational
• Enrollment: 30

Contacts and Locations

Study Locations

• France
  • Alsace
    • Strasbourg, Alsace, France, 67091
      • University Hospital
      • Principal Investigator: Julien POTTECHER, MD
      • Sub-Investigator: François LEVY, MD
      • Sub-Investigator: Mircea Cristinar, MD
      • Sub-Investigator: Ghaib Ajob, MD
      • Sub-Investigator: Matthieu Zappaterra, MD
      • Sub-Investigator: Adrien Thibaud, MD
      • Sub-Investigator: Wim Skibba, MD
      • Sub-Investigator: Jean-Claude Thiranos, MD
      • Sub-Investigator: Olivier COLLANGE, MD
      • Sub-Investigator: Sandrine Marguerite, MD
      • Sub-Investigator: Jean-Paul Schmitt, MD
      • Sub-Investigator: Hubert GROS, MD
      • Sub-Investigator: Anne-Lise Maechel, MD
      • Sub-Investigator: Paul-Michel Mertes, MD
      • Sub-Investigator: Giedrius Laurinenas, MD
      • Sub-Investigator: Amir Samet, MD
      • Sub-Investigator: Cécile Gros, MD
      • Sub-Investigator: Annick Steib, PhD
      • Sub-Investigator: Pierre Diemunsch, PhD
      • Sub-Investigator: Michel KINDO, MD
      • Sub-Investigator: Jean-Philippe Mazzucotelli, PhD
      • Sub-Investigator: Max Guillot, MD
      • Sub-Investigator: Vincent Castelain, PhD
      • Sub-Investigator: Bernard Geny, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Recruitment concerns only patients with high risk of postoperative respiratory failure (SLIP score > 22).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Registration Dates

• First Submitted: November 6, 2012
• First Submitted That Met QC Criteria: November 7, 2012
• First Posted (Estimate): November 8, 2012

Study Record Updates

• Last Update Posted (Estimate): November 8, 2012
• Last Update Submitted That Met QC Criteria: November 7, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 5328