Rate of Left Ventricular Systolic Function's Recuperation After Cardiac Surgery With Extracorporeal Circulation.

NCT02770183 | Withdrawn

• 1 other identifier: CERU-1601
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The rational of the study is the description of the evolution of systolic cardiac function post-stunning, evaluated by transesophageal minimally invasive echocardiography (hTEE). The uses of these non-invasive methods have proved to be accurate for the qualitative and semi-quantitative determination of the contractile function of the left ventricle and the volume status of the patient. Furthermore the use of this technique has been demonstrated to be a reliable method to analyze the stunning recovery infarction after controlled cardiac arrest during the extra-corporeal circulation.

Conditions

Myocardial Stunning; Transesophageal Echocardiography; Circulation, Extracorporeal

Keywords

Myocardial stunning; Echocardiography, Transesophageal; Extracorporeal Circulation

Outcome Measures

Primary Outcomes (1)

• Fractional Area Change analysis

  Primary outcome is the evolution of Fractional Area Change for the duration of the study. The assessment of cardiac contractile function, which method is better described below, will be based mainly on a serial analysis of the Fractional Area Change and semi-quantitative assessment of ejection fraction in projection 4 cavities.

  72 hours

Secondary Outcomes (1)

• Stratify patients

  72 hours

Study Arms (1)

Consecutive patients

Consecutive patients waiting to have elective cardiac surgery will be eligible. Each week the principal investigator will track patients in the operating program. The day of the consultation or the day before the operation, one of the investigators will have a talk with the patient to provide information and clarify doubts, also allowing the patient to read and look good all the details before giving its approval. For the screening, the principal investigator will use the criteria of inclusion and exclusion to select patients for the study. The screening uses clinical, laboratory or without other biological information. To minimize confounding factors, it will be taken consecutive patients, that will also be analyzed regarding all known variables that can affect the systolic function, as non-modifiable (age, cardiovascular risk factors, heart-rate variability and preoperative basal systolic function) and modifiable.

Device: Imacor

Interventions

Imacor DEVICE

In ICU, the doctors in charge places the probe in the esophagus, executing a series of morphological evaluations and semi-quantitative evaluations. Each image is saved as a video loop or a static image, to have a basic data for each patient and perform an off-line analysis. At the end of the first recording, the esophageal probe is left in the neutral position in the stomach, to eliminate any risk associated with a local increase of pressure. During the stay in the intensive care unit until the end of the study, the esophageal probe will be left in the neutral position, to run every two hours a new echocardiographic assessment on the main window, similar to the first evaluation, always recording loop-video and photographs, to have a time course of recovery of cardiac contractile function. All images will be stored in a digital archive.

Also known as: hTEE

Consecutive patients

Eligibility Criteria

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

Study Population

All patients waiting to have elective cardiac surgery needing a cardiopulmonary by-pass will be eligible for the study.

You may qualify if:

• Adults (over 18 years), waiting for a heart surgery
• Patients of both sexes
• Patients hospitalized in intensive care after the operation
• Informed consent available

You may not qualify if:

• Patients with contraindications to the placement of a nasogastric tube for the presence of esophageal varices, esophageal lesions or esophageal-gastric complications known.
• Patients with severe sepsis or septic shock, according to international definitions.
• Patients with severe coagulopathy defined as a lower thrombocytopenia at 20 G / L and / or INR\> 2.5 and / or aPTT in the therapeutic range and / or an anti-Xa activity in the ultra-therapeutic range and / or a fibrinogen value less than 1 g / L.
• Patients with poor prognosis.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Related Publications (18)

• Heyndrickx GR, Millard RW, McRitchie RJ, Maroko PR, Vatner SF. Regional myocardial functional and electrophysiological alterations after brief coronary artery occlusion in conscious dogs. J Clin Invest. 1975 Oct;56(4):978-85. doi: 10.1172/JCI108178.

  PMID: 1159098 RESULT

• Braunwald E, Kloner RA. The stunned myocardium: prolonged, postischemic ventricular dysfunction. Circulation. 1982 Dec;66(6):1146-9. doi: 10.1161/01.cir.66.6.1146.

  PMID: 6754130 RESULT

• Marban E. Myocardial stunning and hibernation. The physiology behind the colloquialisms. Circulation. 1991 Feb;83(2):681-8. doi: 10.1161/01.cir.83.2.681. No abstract available.

  PMID: 1991384 RESULT

• Bolli R. Myocardial 'stunning' in man. Circulation. 1992 Dec;86(6):1671-91. doi: 10.1161/01.cir.86.6.1671. No abstract available.

  PMID: 1451239 RESULT

• Warren OJ, Watret AL, de Wit KL, Alexiou C, Vincent C, Darzi AW, Athanasiou T. The inflammatory response to cardiopulmonary bypass: part 2--anti-inflammatory therapeutic strategies. J Cardiothorac Vasc Anesth. 2009 Jun;23(3):384-93. doi: 10.1053/j.jvca.2008.09.007. Epub 2008 Dec 3. No abstract available.

  PMID: 19054695 RESULT

• Wan S, LeClerc JL, Vincent JL. Inflammatory response to cardiopulmonary bypass: mechanisms involved and possible therapeutic strategies. Chest. 1997 Sep;112(3):676-92. doi: 10.1378/chest.112.3.676.

  PMID: 9315800 RESULT

• Day JR, Taylor KM. The systemic inflammatory response syndrome and cardiopulmonary bypass. Int J Surg. 2005;3(2):129-40. doi: 10.1016/j.ijsu.2005.04.002. Epub 2005 Aug 1.

  PMID: 17462274 RESULT

• Dixon B, Santamaria J, Campbell D. Coagulation activation and organ dysfunction following cardiac surgery. Chest. 2005 Jul;128(1):229-36. doi: 10.1378/chest.128.1.229.

  PMID: 16002940 RESULT

• Esmon CT. The interactions between inflammation and coagulation. Br J Haematol. 2005 Nov;131(4):417-30. doi: 10.1111/j.1365-2141.2005.05753.x.

  PMID: 16281932 RESULT

• Compostella L, Russo N, Compostella C, Setzu T, D'Onofrio A, Isabella G, Tarantini G, Iliceto S, Gerosa G, Bellotto F. Impact of type of intervention for aortic valve replacement on heart rate variability. Int J Cardiol. 2015 Oct 15;197:11-5. doi: 10.1016/j.ijcard.2015.06.004. Epub 2015 Jun 14.

  PMID: 26113470 RESULT

• Vieillard-Baron A, Prin S, Chergui K, Dubourg O, Jardin F. Hemodynamic instability in sepsis: bedside assessment by Doppler echocardiography. Am J Respir Crit Care Med. 2003 Dec 1;168(11):1270-6. doi: 10.1164/rccm.200306-816CC. No abstract available.

  PMID: 14644922 RESULT

• Etchecopar-Chevreuil C, Francois B, Clavel M, Pichon N, Gastinne H, Vignon P. Cardiac morphological and functional changes during early septic shock: a transesophageal echocardiographic study. Intensive Care Med. 2008 Feb;34(2):250-6. doi: 10.1007/s00134-007-0929-z. Epub 2007 Nov 15.

  PMID: 18004543 RESULT

• Vignon P, Mentec H, Terre S, Gastinne H, Gueret P, Lemaire F. Diagnostic accuracy and therapeutic impact of transthoracic and transesophageal echocardiography in mechanically ventilated patients in the ICU. Chest. 1994 Dec;106(6):1829-34. doi: 10.1378/chest.106.6.1829.

  PMID: 7988209 RESULT

• Slama MA, Novara A, Van de Putte P, Diebold B, Safavian A, Safar M, Ossart M, Fagon JY. Diagnostic and therapeutic implications of transesophageal echocardiography in medical ICU patients with unexplained shock, hypoxemia, or suspected endocarditis. Intensive Care Med. 1996 Sep;22(9):916-22. doi: 10.1007/BF02044116.

  PMID: 8905426 RESULT

• Vieillard-Baron A, Slama M, Mayo P, Charron C, Amiel JB, Esterez C, Leleu F, Repesse X, Vignon P. A pilot study on safety and clinical utility of a single-use 72-hour indwelling transesophageal echocardiography probe. Intensive Care Med. 2013 Apr;39(4):629-35. doi: 10.1007/s00134-012-2797-4. Epub 2013 Jan 4.

  PMID: 23287876 RESULT

• Treskatsch S, Balzer F, Knebel F, Habicher M, Braun JP, Kastrup M, Grubitzsch H, Wernecke KD, Spies C, Sander M. Feasibility and influence of hTEE monitoring on postoperative management in cardiac surgery patients. Int J Cardiovasc Imaging. 2015 Oct;31(7):1327-35. doi: 10.1007/s10554-015-0689-8. Epub 2015 Jun 6.

  PMID: 26047772 RESULT

• Begot E, Dalmay F, Etchecopar C, Clavel M, Pichon N, Francois B, Lang R, Vignon P. Hemodynamic assessment of ventilated ICU patients with cardiorespiratory failure using a miniaturized multiplane transesophageal echocardiography probe. Intensive Care Med. 2015 Nov;41(11):1886-94. doi: 10.1007/s00134-015-3998-4. Epub 2015 Aug 8.

  PMID: 26254013 RESULT

• Imren Y, Tasoglu I, Oktar GL, Benson A, Naseem T, Cheema FH, Unal Y. The importance of transesophageal echocardiography in diagnosis of pericardial tamponade after cardiac surgery. J Card Surg. 2008 Sep-Oct;23(5):450-3. doi: 10.1111/j.1540-8191.2008.00581.x. Epub 2008 May 7.

  PMID: 18462344 RESULT

MeSH Terms

Conditions

Myocardial Stunning

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karim Bendjelid, Prof.

  University Hospital, Geneva

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 12, 2016
• Study Start: December 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share