Out-of-hospital Cardiac ArrestENTRACTNCT02349074
Digestive ENdoscopy afTeR Out-of-hospitAl Cardiac arresT
A study testing Digestive endoscopy in people with Out-of-hospital Cardiac Arrest, run by Versailles Hospital at 9 sites in 2 countries.
Trial summary
Post-cardiac arrest ischemia/reperfusion phenomenon led to organs injury and failure. Among the different organs, gastro-intestinal tract injury could contribute to post-cardiac arrest shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-hospital Cardiac Arrest
- What is being tested?
- Digestive endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 12 Nov 2014to 1 Sep 2019
- Phase
- Interventional
- 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
Who may be able to join
- Adult patient hospitalized for less than 5 days in a participating Intensive Unit Care following successfully resuscitated out-of-hospital cardiac arrest
- Patient still mechanically ventilated
- Hypothermia period over, corporal temperature > 36°C.
- Written consent from a next of kin
Who cannot join
- In-hospital cardiac arrest
- Patients extubated before gastroscopy
- Contra-indication of gastroscopy: suspicion of digestive perforation, severe bleeding diathesis despite coagulation products transfusion, or suspicion of Creutzfeldt-jacob disease
- Patients with cardiac valvular prosthesis or previous endocarditis
- Pregnancy, lactating women In case of severe coagulation disorders (platelet count < 30 G/L, International Normalized Ratio (INR) > 2) or heparin treatment or combined platelet inhibition treatment, the inclusion of the patient will be possible but digestive biopsies will not be allowed.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
France8 sites
Cotentin Hospital, Medical intensive care unit
Cherbourg-Octeville, 50102
Hospital Louis Mourier
Colombes
Sud Francilien Hospital, Medicla care unit
Corbeil-Essonnes, 91100
Henri Mondor Hospital, Medical Intensive care unit
Créteil, 94010
André Mignot Hospital, Intensive care unit
Le Chesnay, Les Yvelines, 78150
Dupuytren hospital, Medical intensive care unit
Limoges, 87042
Orléans Hospital, Medical intensive care unit
Orléans, 45067
Cochin Hospital, Médical intensive care unit
Paris, 75014
About this study
Post-cardiac arrest ischemia/reperfusion phenomenon led to organs injury and failure. Among the different organs, gastro-intestinal tract injury could contribute to post-cardiac arrest shock.
The ischemic injury of the gastro-intestinal (GI) tractus is suggested by abnormalities in digestive biomarkers and by the frequent endotoxemia after CA. However, direct mucosal damage has not been clearly demonstrated after OHCA. The real incidence of ischemic lesions of GI tract and their potential involvement in the post-CA shock is therefore unknown.
We propose an original clinical research program aimed at rigorously determining the incidence of upper GI lesions after OHCA and analyzing their contribution to the severity of post-CA shock through a prospective, interventional, multicentric study
Read the detailed description
The screening of the patients will be performed 2 to 4 days after their Intensive Care Unit (ICU) admission. Procedure and exams at the day of inclusion (day 0):
- collection of digestive symptoms
- carrying out the œsophago-gastro-duodenoscopy and establishment of a formal report with the eventual lesions and their ischemic nature.
- in the absence of contra-indication and upon final decision of the gastroscopist, systematic biopsies of fundic, antral and duodenal mucosa; contra-indication of biopsies are the presence of a vascular or haemorrhagic lesion and the coagulation disorders.
- Blood sample for H. pylori serology, and serum freezing. Urinary sample for urine freezing
Procedure and exams from day 1 to hospital discharge:
- Daily collection of digestive symptoms and needs for vasopressor support
- Sepsis-related Organ Failure Assessment (SOFA) score at day 2 \& 5
- Cerebral Performance Category (CPC) score determination at hospital discharge In case of digestive symptoms after day 0 and in accordance with good clinical practice, a second gastroscopy and/or an abdominal Computed Tomography scan(CT-scan) and/or a colonoscopy will be performed at the physician's discretion.
- Conditions
- Out-of-hospital Cardiac Arrest
- Being tested
- Digestive endoscopy
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digestive endoscopyProcedure or surgery
Performed a systematic œsophago-gastro-duodenoscopy between 2 and 4 days after out-of-hospital cardiac arrest
| Study group | Role | What they receive |
|---|---|---|
| Digestive endoscopy | Experimental | Performed a systematic œsophago-gastro-duodenoscopy during Intensive Care Unit stay after out-of-hospital cardiac arrest Receives: Procedure: Digestive endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the incidence of upper digestive macroscopic lesions after out-of-hospital cardiac arrest
Performed a systematic œsophago-gastro-duodenoscopy between 2 and 4 days after the cardiac arrest
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study start12 Nov 2014
- Primary completion30 Nov 2018
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Out-of-hospital Cardiac ArrestStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr David GRIMALDI, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349074
- Sponsor's protocol ID
- P13/30 ENTRACT
- Other IDs
- 2014-A00994-43
- Acronym
- ENTRACT
- Status last verified
- May 2022
- First submitted
- 22 Jan 2015
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Dumas F, Grimaldi D, Zuber B, Fichet J, Charpentier J, Pene F, Vivien B, Varenne O, Carli P, Jouven X, Empana JP, Cariou A. Is hypothermia after cardiac arrest effective in both shockable and nonshockable patients?: insights from a large registry. Circulation. 2011 Mar 1;123(8):877-86. doi: 10.1161/CIRCULATIONAHA.110.987347. Epub 2011 Feb 14.
PubMed 21321156Dumas F, Cariou A, Manzo-Silberman S, Grimaldi D, Vivien B, Rosencher J, Empana JP, Carli P, Mira JP, Jouven X, Spaulding C. Immediate percutaneous coronary intervention is associated with better survival after out-of-hospital cardiac arrest: insights from the PROCAT (Parisian Region Out of hospital Cardiac ArresT) registry. Circ Cardiovasc Interv. 2010 Jun 1;3(3):200-7. doi: 10.1161/CIRCINTERVENTIONS.109.913665. Epub 2010 May 18.
PubMed 20484098Mongardon N, Dumas F, Ricome S, Grimaldi D, Hissem T, Pene F, Cariou A. Postcardiac arrest syndrome: from immediate resuscitation to long-term outcome. Ann Intensive Care. 2011 Nov 3;1(1):45. doi: 10.1186/2110-5820-1-45.
PubMed 22053891Lemiale V, Dumas F, Mongardon N, Giovanetti O, Charpentier J, Chiche JD, Carli P, Mira JP, Nolan J, Cariou A. Intensive care unit mortality after cardiac arrest: the relative contribution of shock and brain injury in a large cohort. Intensive Care Med. 2013 Nov;39(11):1972-80. doi: 10.1007/s00134-013-3043-4. Epub 2013 Aug 14.
PubMed 23942856Laver S, Farrow C, Turner D, Nolan J. Mode of death after admission to an intensive care unit following cardiac arrest. Intensive Care Med. 2004 Nov;30(11):2126-8. doi: 10.1007/s00134-004-2425-z. Epub 2004 Sep 9.
PubMed 15365608Laurent I, Monchi M, Chiche JD, Joly LM, Spaulding C, Bourgeois B, Cariou A, Rozenberg A, Carli P, Weber S, Dhainaut JF. Reversible myocardial dysfunction in survivors of out-of-hospital cardiac arrest. J Am Coll Cardiol. 2002 Dec 18;40(12):2110-6. doi: 10.1016/s0735-1097(02)02594-9.
PubMed 12505221Adrie C, Adib-Conquy M, Laurent I, Monchi M, Vinsonneau C, Fitting C, Fraisse F, Dinh-Xuan AT, Carli P, Spaulding C, Dhainaut JF, Cavaillon JM. Successful cardiopulmonary resuscitation after cardiac arrest as a "sepsis-like" syndrome. Circulation. 2002 Jul 30;106(5):562-8. doi: 10.1161/01.cir.0000023891.80661.ad.
PubMed 12147537Adrie C, Laurent I, Monchi M, Cariou A, Dhainaou JF, Spaulding C. Postresuscitation disease after cardiac arrest: a sepsis-like syndrome? Curr Opin Crit Care. 2004 Jun;10(3):208-12. doi: 10.1097/01.ccx.0000126090.06275.fe.
PubMed 15166838Hausenloy DJ, Yellon DM. Myocardial ischemia-reperfusion injury: a neglected therapeutic target. J Clin Invest. 2013 Jan;123(1):92-100. doi: 10.1172/JCI62874. Epub 2013 Jan 2.
PubMed 23281415Kawai T, Akira S. TLR signaling. Semin Immunol. 2007 Feb;19(1):24-32. doi: 10.1016/j.smim.2006.12.004. Epub 2007 Feb 1.
PubMed 17275323Suffredini AF, Fromm RE, Parker MM, Brenner M, Kovacs JA, Wesley RA, Parrillo JE. The cardiovascular response of normal humans to the administration of endotoxin. N Engl J Med. 1989 Aug 3;321(5):280-7. doi: 10.1056/NEJM198908033210503.
PubMed 2664516Balija TM, Lowry SF. Lipopolysaccharide and sepsis-associated myocardial dysfunction. Curr Opin Infect Dis. 2011 Jun;24(3):248-53. doi: 10.1097/QCO.0b013e32834536ce.
PubMed 21378563Zhou J, Huang WQ, Li C, Wu GY, Li YS, Wen SH, Lei WL, Liu KX. Intestinal ischemia/reperfusion enhances microglial activation and induces cerebral injury and memory dysfunction in rats. Crit Care Med. 2012 Aug;40(8):2438-48. doi: 10.1097/CCM.0b013e3182546855.
PubMed 22647410Marshall JC, Foster D, Vincent JL, Cook DJ, Cohen J, Dellinger RP, Opal S, Abraham E, Brett SJ, Smith T, Mehta S, Derzko A, Romaschin A; MEDIC study. Diagnostic and prognostic implications of endotoxemia in critical illness: results of the MEDIC study. J Infect Dis. 2004 Aug 1;190(3):527-34. doi: 10.1086/422254. Epub 2004 Jul 2.
PubMed 15243928Korth U, Krieter H, Denz C, Janke C, Ellinger K, Bertsch T, Henn C, Klein J. Intestinal ischaemia during cardiac arrest and resuscitation: comparative analysis of extracellular metabolites by microdialysis. Resuscitation. 2003 Aug;58(2):209-17. doi: 10.1016/s0300-9572(03)00119-9.
PubMed 12909384
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digestive ENdoscopy afTeR Out-of-hospitAl Cardiac arresT
- ClinicalTrials.gov ID
- NCT02349074
- Acronym / sponsor ID
- ENTRACT / P13/30 ENTRACT
- Conditions
- Out-of-hospital Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 12 Nov 2014 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 28 Jan 2015 (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.
Post-cardiac arrest ischemia/reperfusion phenomenon led to organs injury and failure. Among the different organs, gastro-intestinal tract injury could contribute to post-cardiac arrest shock.
The ischemic injury of the gastro-intestinal (GI) tractus is suggested by abnormalities in digestive biomarkers and by the frequent endotoxemia after CA. However, direct mucosal damage has not been clearly demonstrated after OHCA. The real incidence of ischemic lesions of GI tract and their potential involvement in the post-CA shock is therefore unknown.
We propose an original clinical research program aimed at rigorously determining the incidence of upper GI lesions after OHCA and analyzing their contribution to the severity of post-CA shock through a prospective, interventional, multicentric study
Detailed description
The screening of the patients will be performed 2 to 4 days after their Intensive Care Unit (ICU) admission. Procedure and exams at the day of inclusion (day 0):
- collection of digestive symptoms
- carrying out the œsophago-gastro-duodenoscopy and establishment of a formal report with the eventual lesions and their ischemic nature.
- in the absence of contra-indication and upon final decision of the gastroscopist, systematic biopsies of fundic, antral and duodenal mucosa; contra-indication of biopsies are the presence of a vascular or haemorrhagic lesion and the coagulation disorders.
- Blood sample for H. pylori serology, and serum freezing. Urinary sample for urine freezing
Procedure and exams from day 1 to hospital discharge:
- Daily collection of digestive symptoms and needs for vasopressor support
- Sepsis-related Organ Failure Assessment (SOFA) score at day 2 \& 5
- Cerebral Performance Category (CPC) score determination at hospital discharge In case of digestive symptoms after day 0 and in accordance with good clinical practice, a second gastroscopy and/or an abdominal Computed Tomography scan(CT-scan) and/or a colonoscopy will be performed at the physician's discretion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digestive endoscopy | Experimental | Procedure: Digestive endoscopyPerformed a systematic œsophago-gastro-duodenoscopy during Intensive Care Unit stay after out-of-hospital cardiac arrest |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient hospitalized for less than 5 days in a participating Intensive Unit Care following successfully resuscitated out-of-hospital cardiac arrest
- Patient still mechanically ventilated
- Hypothermia period over, corporal temperature > 36°C.
- Written consent from a next of kin
Key exclusion criteria (5 listed)
- In-hospital cardiac arrest
- Patients extubated before gastroscopy
- Contra-indication of gastroscopy: suspicion of digestive perforation, severe bleeding diathesis despite coagulation products transfusion, or suspicion of Creutzfeldt-jacob disease
- Patients with cardiac valvular prosthesis or previous endocarditis
- Pregnancy, lactating women In case of severe coagulation disorders (platelet count < 30 G/L, International Normalized Ratio (INR) > 2) or heparin treatment or combined platelet inhibition treatment, the inclusion of the patient will be possible but digestive biopsies will not be allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digestive endoscopyPerformed a systematic œsophago-gastro-duodenoscopy between 2 and 4 days after out-of-hospital cardiac arrest | Procedure or surgery | Digestive endoscopy |
Primary outcome
To measure the incidence of upper digestive macroscopic lesions after out-of-hospital cardiac arrest
Time frame: One day
Performed a systematic œsophago-gastro-duodenoscopy between 2 and 4 days after the cardiac arrest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Background: PubMed 21321156Dumas F, Grimaldi D, Zuber B, Fichet J, Charpentier J, Pene F, Vivien B, Varenne O, Carli P, Jouven X, Empana JP, Cariou A. Is hypothermia after cardiac arrest effective in both shockable and nonshockable patients?: insights from a large registry. Circulation. 2011 Mar 1;123(8):877-86. doi: 10.1161/CIRCULATIONAHA.110.987347. Epub 2011 Feb 14.
- Background: PubMed 20484098Dumas F, Cariou A, Manzo-Silberman S, Grimaldi D, Vivien B, Rosencher J, Empana JP, Carli P, Mira JP, Jouven X, Spaulding C. Immediate percutaneous coronary intervention is associated with better survival after out-of-hospital cardiac arrest: insights from the PROCAT (Parisian Region Out of hospital Cardiac ArresT) registry. Circ Cardiovasc Interv. 2010 Jun 1;3(3):200-7. doi: 10.1161/CIRCINTERVENTIONS.109.913665. Epub 2010 May 18.
- Background: PubMed 22053891Mongardon N, Dumas F, Ricome S, Grimaldi D, Hissem T, Pene F, Cariou A. Postcardiac arrest syndrome: from immediate resuscitation to long-term outcome. Ann Intensive Care. 2011 Nov 3;1(1):45. doi: 10.1186/2110-5820-1-45.
- Background: PubMed 23942856Lemiale V, Dumas F, Mongardon N, Giovanetti O, Charpentier J, Chiche JD, Carli P, Mira JP, Nolan J, Cariou A. Intensive care unit mortality after cardiac arrest: the relative contribution of shock and brain injury in a large cohort. Intensive Care Med. 2013 Nov;39(11):1972-80. doi: 10.1007/s00134-013-3043-4. Epub 2013 Aug 14.
- Background: PubMed 15365608Laver S, Farrow C, Turner D, Nolan J. Mode of death after admission to an intensive care unit following cardiac arrest. Intensive Care Med. 2004 Nov;30(11):2126-8. doi: 10.1007/s00134-004-2425-z. Epub 2004 Sep 9.
- Background: PubMed 12505221Laurent I, Monchi M, Chiche JD, Joly LM, Spaulding C, Bourgeois B, Cariou A, Rozenberg A, Carli P, Weber S, Dhainaut JF. Reversible myocardial dysfunction in survivors of out-of-hospital cardiac arrest. J Am Coll Cardiol. 2002 Dec 18;40(12):2110-6. doi: 10.1016/s0735-1097(02)02594-9.
- Background: PubMed 12147537Adrie C, Adib-Conquy M, Laurent I, Monchi M, Vinsonneau C, Fitting C, Fraisse F, Dinh-Xuan AT, Carli P, Spaulding C, Dhainaut JF, Cavaillon JM. Successful cardiopulmonary resuscitation after cardiac arrest as a "sepsis-like" syndrome. Circulation. 2002 Jul 30;106(5):562-8. doi: 10.1161/01.cir.0000023891.80661.ad.
- Background: PubMed 15166838Adrie C, Laurent I, Monchi M, Cariou A, Dhainaou JF, Spaulding C. Postresuscitation disease after cardiac arrest: a sepsis-like syndrome? Curr Opin Crit Care. 2004 Jun;10(3):208-12. doi: 10.1097/01.ccx.0000126090.06275.fe.
- Background: PubMed 23281415Hausenloy DJ, Yellon DM. Myocardial ischemia-reperfusion injury: a neglected therapeutic target. J Clin Invest. 2013 Jan;123(1):92-100. doi: 10.1172/JCI62874. Epub 2013 Jan 2.
- Background: PubMed 17275323Kawai T, Akira S. TLR signaling. Semin Immunol. 2007 Feb;19(1):24-32. doi: 10.1016/j.smim.2006.12.004. Epub 2007 Feb 1.
- Background: PubMed 2664516Suffredini AF, Fromm RE, Parker MM, Brenner M, Kovacs JA, Wesley RA, Parrillo JE. The cardiovascular response of normal humans to the administration of endotoxin. N Engl J Med. 1989 Aug 3;321(5):280-7. doi: 10.1056/NEJM198908033210503.
- Background: PubMed 21378563Balija TM, Lowry SF. Lipopolysaccharide and sepsis-associated myocardial dysfunction. Curr Opin Infect Dis. 2011 Jun;24(3):248-53. doi: 10.1097/QCO.0b013e32834536ce.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digestive endoscopy in people with Out-of-hospital Cardiac Arrest, run by Versailles Hospital at 9 sites in 2 countries.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the incidence of upper digestive macroscopic lesions after out-of-hospital cardiac arrest (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02349074, which also lists 29 linked publications.
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 27 May 2022.