Acute Respiratory Distress Syndrome After Cardiac Surgery Under Cardiopulmonary BypassNCT01723930
Transpulmonary Gradient After Cardiac Surgery Under Cardiopulmonary Bypass
An observational study of Acute Respiratory Distress Syndrome After Cardiac Surgery Under Cardiopulmonary Bypass, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome After Cardiac Surgery Under Cardiopulmonary Bypass
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recruitment concerns only patients with high risk of postoperative respiratory failure (SLIP score > 22).
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- Patient placed under guardianship
- Pregnancy
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital
Strasbourg, Alsace, 67091
Julien POTTECHER, MD
Mircea Cristinar, MD
About this study
Official title: 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome After Cardiac Surgery Under Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723930
- Sponsor's protocol ID
- 5328
- Status last verified
- Nov 2012
- First submitted
- 6 Nov 2012
- Last updated
- 8 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transpulmonary Gradient of Inflammation Biomarkers and Pulmonary Vascular Resistance in Acute Respiratory Failure After Cardiac Surgery Under Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT01723930
- Acronym / sponsor ID
- 5328
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- First posted
- 8 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment concerns only patients with high risk of postoperative respiratory failure (SLIP score > 22).
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
transpulmonary gradients of inflammation biomarkers (sRAGE, sICAM-1, SPB, PAI-1, ROS) and pulmonary vascular resistance
Time frame: during the surgery
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome After Cardiac Surgery Under Cardiopulmonary Bypass, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien POTTECHER, MD (03 88 12 70 95, julien.pottecher@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
transpulmonary gradients of inflammation biomarkers (sRAGE, sICAM-1, SPB, PAI-1, ROS) and pulmonary vascular resistance (time frame: during the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2012.