Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction

Not Applicable

Completed

• Conditions: Cardiogenic Shock; Acute; Myocardial Infarction, Complications
• Interventions: Procedure: Mild hypothermia

• Registration Number: NCT01890317
• Lead Sponsor: University of Leipzig

Brief Summary

Prospective, randomized, single-center, controlled, open-label Pilot-study to investigate whether induction of mild hypothermia in addition to primary percutaneous coronary intervention and optimal medical therapy in myocardial infarction complicated by cardiogenic shock improves cardiac power index after 24 h.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-06-24
• Study First Submitted QC: 2013-06-26
• Study First Posted: 2013-07-01
• Primary Completion: 2015-11
• Study Completion: 2016-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-03
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Acute myocardial infarction complicated by cardiongenic shock
• Patients on mechanical ventilation at time of randomization

Exclusion Criteria

• Out of hospital resuscitation with indication for mild hypothermia
• mechanical complications after acute myocardial infarction
• duration of cardiogenic shock > 12 hours
• age > 90 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild hypothermia	Mild hypothermia	Induction of mild hypothermia for 24 hr with invasive cooling in addition to primary percutaneous coronary intervention and optimal medical therapy

Primary Outcome Measures

Name	Time	Method
Cardiac Power Index after 24 hr.	24 hours	Cardiac Power Index after 24 hours as surrogate endpoint.

Secondary Outcome Measures

Name	Time	Method
30-days mortality	30 days
Length of mechanical ventilation	30 days
Catecholamine dose and duration of catecholamine support	30 days
Length of ICU-stay	30 days
SAPS-II-Score	96 hours	Simplified Acute Physiology Score for the first 4 days
Sepsis	30 days
Stroke	30 days
Change of hemodynamics over the first 48 hr.	During first 48 hr
Severe and moderate bleeding complications (GUSTO-definition)	30 days
Pneumonia	30 days

Trial Locations

Locations (1)

Department of Internal Medicine/Cardiology, University of Leipzig - Heart Center; 🇩🇪 Leipzig, Sachsen, Germany