Clinical Trial: Hypothermia or Normothermia-Targeted Temperature Management After Out-of-hospital Cardiac Arrest-trial
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Hypothermia or Normothermia-Targeted Temperature Management After Out-of-hospital Cardiac Arrest. A Randomized, Parallel Groups, Assessor Blinded, Clinical Trial
Brief Summary: ILCOR guidelines recommend Target Temperature Management (TTM) to between 32°C and 36°C after out-of-hospital cardiac arrest, based on low quality evidence. In a previous trial, TTM at 33°C did not confer a survival benefit or improved neurological function, compared to TTM at 36°C. A lower target temperature might be beneficial compared with normothermia and early treatment of fever. Therefore the primary purpose of the TTM2-trial will be to study any differences in mortality, neurological function and quality of life between a target temperature of 33°C and standard care avoiding fever.
Detailed Summary:
The TTM2 trial is a continuation of the collaboration that resulted in the previous Targeted Temperature Management after out-of-hospital cardiac arrest trial (hereafter: TTM1). With its planned size with it will supersede the TTM1 trial as the largest trial on temperature management as a post-cardiac arrest treatment.
The TTM1 trial (NCT01020916) was a multicenter, multinational, outcome assessor-blinded, parallel group, randomised clinical trial comparing two strict target temperature regimens of 33°C and 36°C in adult patients, who have sustained return of spontaneous circulation and are unconscious after out-of-hospital cardiac arrest, when admitted to hospital. The trial did not demonstrate any difference in survival until end of trial (Hazard Ratio with a point estimate in favour of 36°C of 1.06 (95% confidence interval 0.89-1.28; P=0.51) or neurologic function at six months after the arrest, measured with CPC and mRS.
The planned study is a international, multicenter, parallel group, non-commerical, randomized, superiority trial in which a target temperature om 33°C after cardiac arrest will be compared to normothermia and early treatment of fever.
Patients eligible for inclusion will be unconscious adult patients with OHCA of a presumed cardiac cause with stable return of spontaneous circulation. Randomization will be performed by a physician in the emergency department, in the angiography suite or in the intensive care unit via web-based application using permuted blocks with varying sizes, stratified by site. Due to the nature of the intervention, health care staff will not be blinded to the intervention. However, the physicians who will assess outcomes will be blinded to temperature allocation, as will those who perform prognostication.
Current Primary Outcome: Mortality [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Survival until end of the trial [ Time Frame: 180 days after randomization of last patient ]
- Impairment [ Time Frame: 180 days ]Overall impairment assessed by the Glasgow Outcome Scale-extended (GOS-E)
- Quality of Life [ Time Frame: 180 days ]Health-related Quality of Life (EQ5-D)
Original Secondary Outcome:
- Survival until end of the trial [ Time Frame: 180 days after randomization of last patient ]
- Impairment [ Time Frame: 180 days ]Overall impairment assessed by the Glasgow Outcome Scale-extended (GOS-E)
- Adverse event - Arrhythmia [ Time Frame: 7 days ]Arrhythmias necessitating treatment (Day 1-7)
- Adverse event - Electrolyte Disorders [ Time Frame: 7 days ]Electrolyte disorders during intensive care (Day 1-7)
- Adverse event - Bleeding [ Time Frame: 7 days ]Bleeding during intensive care (Day 1-7)
- Adverse event - Circulatory shock [ Time Frame: 7 days ]Circulatory shock (Day 1-7)
- Adverse event - Hyperglycemia [ Time Frame: 7 days ]Hyperglycemia <10 mmol/l during intensive care (Day 1-7)
- Adverse event - Hypoglycemia [ Time Frame: 7 days ]Hyperglycemia <3 mmol/l during intensive care (Day 1-7)
- Adverse event - Sepsis [ Time Frame: 7 days ]Sepsis and Septic shock (Day 1-7)
- Adverse event - RRT [ Time Frame: 7 days ]Renal Replacement Therapy (Day 1-7)
- Quality of Life [ Time Frame: 180 days ]Health-related Quality of Life (EQ5-D)
Information By: Helsingborgs Hospital
Dates:
Date Received: September 16, 2016
Date Started: September 1, 2017
Date Completion: December 2021
Last Updated: February 13, 2017
Last Verified: September 2016
