Hypotension During Extracorporeal Circulatory Support Indicated for Cardiogenic Shock

NCT03968926 | Unknown

• 1 other identifier: RECHMPL19_0049
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The cardiogenic shock is characterized by an alteration of organs function following a decrease in cardiac output linked to an impairment of cardiac performance. The prognosis remains poor with mortality between 40 and 50%. Nowadays, Extracorporeal Life Support (ECLS or VA-ECMO) is the referent therapy to restore blood flow in the body when medical treatment is not sufficient. Despite a good blood flow provided by the ECLS, many patients develop a severe hypotension (so called vasoplegia) due to a loss of vascular resistance mainly explained by the inflammatory response to shock and extracorporeal circulation. The treatment of this reaction includes vasopressors (Norepinephrine in usual care) and serum surrogate perfusion to achieve a mean arterial pressure (MAP) above 65 mmHg. The purpose of this study is to describe the patients with vasoplegia among a retrospective cohort of patients treated with an ECLS in our university center, over the 4 last years, to determine major complication rate (including death, kidney failure and arrythmias) and their outcome. This study will provide consistent data useful for further trials about targets of pressure and treatments to increase blood pressure during ECLS.

Conditions

Extracorporeal Life Support; Hypotension; Vasoplegia

Keywords

Cardiogenic shock; Temporary circulatory support; Vasoplegia; Inflammatory response

Outcome Measures

Primary Outcomes (1)

• Major complication composite criteria

  Observation of acute kidney injury defined by KDIGO classification 2 or 3, or severe arrythmia (i.e. atrial fibrillation with heart rate above 150bpm or a mean arterial pressure decrease of at least 20%, sustained ventricular tachycardia, ventricular fibrillation), or death

  Up to 7 days for acute kidney injury and arrythmia, and 30 days for death

Secondary Outcomes (17)

• Initial refractory hypotension

  Up to 2 hours

• Refractory vasoplegia

  Up to 7 days

• Mortality rate

  Through ICU discharge, an average of 1 month, up to 7, 30 and 90 days

• VA-ECMO free days

  At 30 days from the VA-ECMO implantation

• Mean arterial pressure

  Up to 7 days

Study Arms (1)

Vasoplegic ECMO

All patients during VA-ECMO support for cardiogenic shock who presented, within 48 hours after implantation, a vasoplegia defined by a norepinephrine dose greater than 0.1µg/kg/min after a 500ml fluid challenge despite overall blood flow (ECMO + native heart) greater than 2l/min/m2 or allowing to achieve 65% of ScvO2

Other: Arterial pressure management during circulatory support by VA-ECMO

Interventions

Arterial pressure management during circulatory support by VA-ECMO OTHER

Norepinephrine continuous infusion to maintain mean arterial pressure above 65 mmHg or at a higher level depending of the perfusion pressure targeted for the patient (mean arterial pressure between 65 and 85 mmHg)

Vasoplegic ECMO

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted in intensive care unit for cardiogenic shock at the Montpellier University Hospital and who required a VA-ECMO implantation

You may qualify if:

• Refractory cardiogenic shock due to an acute coronary syndrome, a decompensation of chronic heart failure, a infectious or adrenergic myocarditis, or in a post-cardiotomy setting
• Admitted in our intensive care unit between January 2015 and December 2018
• Vasoplegia during the first 48 hours of VA-ECMO requiring more than 0.1µg/kg/min of Norepinephrine continuous infusion

You may not qualify if:

• Others etiologies of cardiogenic shock : heart transplant dysfunction, right ventricular failure after left ventricular assist device implantation, drug intoxication, hypothermia, pulmonary embolism
• Primary septic shock
• Cardiac arrest with a no-flow time greater than 5 min or a low-flow time greater than 45 min
• Opposition to participate after reception of the information letter

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

RECRUITING

Related Publications (2)

• van Diepen S, Katz JN, Albert NM, Henry TD, Jacobs AK, Kapur NK, Kilic A, Menon V, Ohman EM, Sweitzer NK, Thiele H, Washam JB, Cohen MG; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Quality of Care and Outcomes Research; and Mission: Lifeline. Contemporary Management of Cardiogenic Shock: A Scientific Statement From the American Heart Association. Circulation. 2017 Oct 17;136(16):e232-e268. doi: 10.1161/CIR.0000000000000525. Epub 2017 Sep 18.

  PMID: 28923988 BACKGROUND

• Tanaka D, Shimada S, Mullin M, Kreitler K, Cavarocchi N, Hirose H. What Is the Optimal Blood Pressure on Veno-Arterial Extracorporeal Membrane Oxygenation? Impact of Mean Arterial Pressure on Survival. ASAIO J. 2019 May/Jun;65(4):336-341. doi: 10.1097/MAT.0000000000000824.

  PMID: 29762229 BACKGROUND

Biospecimen

Retention: NONE RETAINED

Plasma: preoperative, ICU admission at POD0 and POD1 samples

MeSH Terms

Conditions

Hypotension; Vasoplegia; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Necrosis; Shock

Study Officials

• Philippe Gaudard, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Gaudard, MD

CONTACT

+33665849543; p-gaudard@chu-montpellier.fr

Helene David, MD

CONTACT

629834346; h-david@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 30, 2019
• Study Start: June 30, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 30, 2020
• Last Updated: March 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)