Digestive ENdoscopy afTeR Out-of-hospitAl Cardiac arresT

NCT02349074 | Completed

• 2 other identifiers: P13/30 ENTRACT2014-A00994-43
• Study Type: interventional
• Target: 221
• Locations: 2 countries
• Sites: 9

Brief 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. 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

Conditions

Out-of-hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• 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

  One day

Study Arms (1)

Digestive endoscopy

EXPERIMENTAL

Performed a systematic œsophago-gastro-duodenoscopy during Intensive Care Unit stay after out-of-hospital cardiac arrest

Procedure: Digestive endoscopy

Interventions

Digestive endoscopy PROCEDURE

Performed a systematic œsophago-gastro-duodenoscopy between 2 and 4 days after out-of-hospital cardiac arrest

Digestive endoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Versailles Hospital: lead

Study Sites (9)

Hospital Erasme

Brussels, Belgium

Location

André Mignot Hospital, Intensive care unit

Le Chesnay, Les Yvelines, 78150, France

Location

Cotentin Hospital, Medical intensive care unit

Cherbourg-Octeville, 50102, France

Location

Hospital Louis Mourier

Colombes, France

Location

Sud Francilien Hospital, Medicla care unit

Corbeil-Essonnes, 91100, France

Location

Henri Mondor Hospital, Medical Intensive care unit

Créteil, 94010, France

Location

Dupuytren hospital, Medical intensive care unit

Limoges, 87042, France

Location

Orléans Hospital, Medical intensive care unit

Orléans, 45067, France

Location

Cochin Hospital, Médical intensive care unit

Paris, 75014, France

Location

Related Publications (29)

• 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.

  PMID: 21321156 BACKGROUND

• Dumas 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.

  PMID: 20484098 BACKGROUND

• Mongardon 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.

  PMID: 22053891 BACKGROUND

• Lemiale 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.

  PMID: 23942856 BACKGROUND

• Laver 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.

  PMID: 15365608 BACKGROUND

• Laurent 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.

  PMID: 12505221 BACKGROUND

• Adrie 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.

  PMID: 12147537 BACKGROUND

• Adrie 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.

  PMID: 15166838 BACKGROUND

• Hausenloy 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.

  PMID: 23281415 BACKGROUND

• Kawai 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.

  PMID: 17275323 BACKGROUND

• Suffredini 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.

  PMID: 2664516 BACKGROUND

• Balija TM, Lowry SF. Lipopolysaccharide and sepsis-associated myocardial dysfunction. Curr Opin Infect Dis. 2011 Jun;24(3):248-53. doi: 10.1097/QCO.0b013e32834536ce.

  PMID: 21378563 BACKGROUND

• Zhou 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.

  PMID: 22647410 BACKGROUND

• Marshall 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.

  PMID: 15243928 BACKGROUND

• Korth 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.

  PMID: 12909384 BACKGROUND

• Gill RS, Lee TF, Sergi C, Bigam DL, Cheung PY. Early versus delayed cyclosporine treatment in cardiac recovery and intestinal injury during resuscitation of asphyxiated newborn piglets. Intensive Care Med. 2012 Jul;38(7):1215-23. doi: 10.1007/s00134-012-2577-1. Epub 2012 May 10.

  PMID: 22572838 BACKGROUND

• Albrecht M, Gruenewald M, Zitta K, Zacharowski K, Scholz J, Bein B, Meybohm P. Hypothermia and anesthetic postconditioning influence the expression and activity of small intestinal proteins possibly involved in ischemia/reperfusion-mediated events following cardiopulmonary resuscitation. Resuscitation. 2012 Jan;83(1):113-8. doi: 10.1016/j.resuscitation.2011.06.038. Epub 2011 Jul 18.

  PMID: 21763251 BACKGROUND

• Gill RS, Manouchehri N, Lee TF, Cho WJ, Thiesen A, Churchill T, Bigam DL, Cheung PY. Cyclosporine treatment improves mesenteric perfusion and attenuates necrotizing enterocolitis (NEC)-like intestinal injury in asphyxiated newborn piglets during reoxygenation. Intensive Care Med. 2012 Mar;38(3):482-90. doi: 10.1007/s00134-011-2436-5. Epub 2011 Dec 6.

  PMID: 22143394 BACKGROUND

• Bedell SE, Fulton EJ. Unexpected findings and complications at autopsy after cardiopulmonary resuscitation (CPR). Arch Intern Med. 1986 Sep;146(9):1725-8.

  PMID: 3753112 BACKGROUND

• Piton G, Barbot O, Manzon C, Moronval F, Patry C, Navellou JC, Belle E, Capellier G. Acute ischemic pancreatitis following cardiac arrest: a case report. JOP. 2010 Sep 6;11(5):456-9.

  PMID: 20818115 BACKGROUND

• Gaussorgues P, Gueugniaud PY, Vedrinne JM, Salord F, Mercatello A, Robert D. Bacteremia following cardiac arrest and cardiopulmonary resuscitation. Intensive Care Med. 1988;14(5):575-7. doi: 10.1007/BF00263532.

  PMID: 3221011 BACKGROUND

• Grootjans J, Lenaerts K, Derikx JP, Matthijsen RA, de Bruine AP, van Bijnen AA, van Dam RM, Dejong CH, Buurman WA. Human intestinal ischemia-reperfusion-induced inflammation characterized: experiences from a new translational model. Am J Pathol. 2010 May;176(5):2283-91. doi: 10.2353/ajpath.2010.091069. Epub 2010 Mar 26.

  PMID: 20348235 BACKGROUND

• Thuijls G, van Wijck K, Grootjans J, Derikx JP, van Bijnen AA, Heineman E, Dejong CH, Buurman WA, Poeze M. Early diagnosis of intestinal ischemia using urinary and plasma fatty acid binding proteins. Ann Surg. 2011 Feb;253(2):303-8. doi: 10.1097/SLA.0b013e318207a767.

  PMID: 21245670 BACKGROUND

• Crenn P, Messing B, Cynober L. Citrulline as a biomarker of intestinal failure due to enterocyte mass reduction. Clin Nutr. 2008 Jun;27(3):328-39. doi: 10.1016/j.clnu.2008.02.005. Epub 2008 Apr 28.

  PMID: 18440672 BACKGROUND

• Grimaldi D, Guivarch E, Neveux N, Fichet J, Pene F, Marx JS, Chiche JD, Cynober L, Mira JP, Cariou A. Markers of intestinal injury are associated with endotoxemia in successfully resuscitated patients. Resuscitation. 2013 Jan;84(1):60-5. doi: 10.1016/j.resuscitation.2012.06.010. Epub 2012 Jun 26.

  PMID: 22743354 BACKGROUND

• L'Her E, Cassaz C, Le Gal G, Cholet F, Renault A, Boles JM. Gut dysfunction and endoscopic lesions after out-of-hospital cardiac arrest. Resuscitation. 2005 Sep;66(3):331-4. doi: 10.1016/j.resuscitation.2005.03.016.

  PMID: 16039032 BACKGROUND

• Jacobs I, Nadkarni V, Bahr J, Berg RA, Billi JE, Bossaert L, Cassan P, Coovadia A, D'Este K, Finn J, Halperin H, Handley A, Herlitz J, Hickey R, Idris A, Kloeck W, Larkin GL, Mancini ME, Mason P, Mears G, Monsieurs K, Montgomery W, Morley P, Nichol G, Nolan J, Okada K, Perlman J, Shuster M, Steen PA, Sterz F, Tibballs J, Timerman S, Truitt T, Zideman D; International Liason Committee on Resusitation. Cardiac arrest and cardiopulmonary resuscitation outcome reports: update and simplification of the Utstein templates for resuscitation registries. A statement for healthcare professionals from a task force of the international liaison committee on resuscitation (American Heart Association, European Resuscitation Council, Australian Resuscitation Council, New Zealand Resuscitation Council, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Southern Africa). Resuscitation. 2004 Dec;63(3):233-49. doi: 10.1016/j.resuscitation.2004.09.008.

  PMID: 15582757 BACKGROUND

• Savoye G, Ben Soussan E, Hochain P, Lerebours E. [How and how far to investigate ischemic colitis?]. Gastroenterol Clin Biol. 2002 May;26(5 Suppl):B12-23. No abstract available. French.

  PMID: 12068266 BACKGROUND

• Grimaldi D, Legriel S, Pichon N, Colardelle P, Leblanc S, Canoui-Poitrine F, Ben Hadj Salem O, Muller G, de Prost N, Herrmann S, Marque S, Baron A, Sauneuf B, Messika J, Dior M, Creteur J, Bedos JP, Boutin E, Cariou A. Ischemic injury of the upper gastrointestinal tract after out-of-hospital cardiac arrest: a prospective, multicenter study. Crit Care. 2022 Mar 14;26(1):59. doi: 10.1186/s13054-022-03939-9.

  PMID: 35287719 DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator coordinator

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: January 28, 2015
• Study Start: November 12, 2014
• Primary Completion: November 30, 2018
• Study Completion: September 1, 2019
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

FR (8); BE (1)