Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction

Cardiogenic Shock Clinical Trial

— SHOCK-COOL  

Official title:

Randomized Pilot Study of Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01890317
• Other study ID #: HZLCOOL1
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: March 2016

Study information

• Verified date: July 2018
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute; Myocardial Infarction, Complications
• Cardiogenic Shock
• Hypothermia
• Infarction
• Myocardial Infarction
• Shock
• Shock, Cardiogenic

Intervention

Procedure:
• Mild hypothermia
Induction of mild hypothermia with invasive cooling for 24 hr in addition to primary percutaneous coronary intervention and optimal medical therapy.

Locations

Country	Name	City	State
Germany	Department of Internal Medicine/Cardiology, University of Leipzig - Heart Center	Leipzig	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Power Index after 24 hr.	Cardiac Power Index after 24 hours as surrogate endpoint.	24 hours
Secondary	30-days mortality		30 days
Secondary	Change of hemodynamics over the first 48 hr.		During first 48 hr
Secondary	Catecholamine dose and duration of catecholamine support		30 days
Secondary	Length of ICU-stay		30 days
Secondary	Length of mechanical ventilation		30 days
Secondary	SAPS-II-Score	Simplified Acute Physiology Score for the first 4 days	96 hours
Secondary	Severe and moderate bleeding complications (GUSTO-definition)		30 days
Secondary	Sepsis		30 days
Secondary	Pneumonia		30 days
Secondary	Stroke		30 days