Clinical Trial: Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: University of Leipzig

Current Primary Outcome: Cardiac Power Index after 24 hr. [ Time Frame: 24 hours ]

Cardiac Power Index after 24 hours as surrogate endpoint.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University of Leipzig

Dates:
Date Received: June 24, 2013
Date Started: August 2012
Date Completion:
Last Updated: May 1, 2017
Last Verified: May 2017