Primary objective: To evaluate whether there is a difference in all-cause mortality at 180 days or longer with a target temperature management at 33°C compared to a target temperature of 36°C, in patients unconscious after out-of-hospital OHCA.…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Encephalopathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: All-cause mortality at maximal follow up (at least 180 days).
Secondary outcome
Secondary outcomes: Composite outcome of all-cause mortality and poor
neurological function (Cerebral Performance Category 3 and 4) at hospital
discharge and at 180 days. All-cause mortality and cerebral performance
category at hospital discharge and at 180-days. Best neurological outcome
during trial period. Cognitive status at 180 days. Neuron specific enolase at
48 and 72 hours. Bleeding, pneumonia, sepsis, electrolyte disorders,
hyperglycaemia, hypoglycaemia, cardiac arrhythmia, renal replacement therapy.
Background summary
Experimental studies and previous clinical trials suggest an improvement in
mortality and neurological function with hypothermia after cardiac arrest but
the present data is inconclusive and the optimal temperature is not known.
Study objective
Primary objective: To evaluate whether there is a difference in all-cause
mortality at 180 days or longer with a target temperature management at 33°C
compared to a target temperature of 36°C, in patients unconscious after
out-of-hospital OHCA.
Secondary objective: To evaluate whether there is a difference in the composite
outcome of all-cause mortality and poor neurological function at hospital
discharge and at 180 days with a target temperature management at 33°C compared
to a target temperature of 36°C, in patients unconscious after out-of-hospital
OHCA. To assess safety with target temperature management with regard to
infection, cardiac arrhythmia, electrolyte disorders and bleeding.
Study design
Design: Multicentre, international, randomised trial with 1:1 concealed
allocation of 850 out-of-hospital cardiac arrest patients to temperature
control for 24 h at 33°C versus 36°C with blinded outcome assessment.
Intervention
Patients will be managed with 24 hours temperature control at 33°C versus 36°C
according to randomisation. Temperature control will be delivered with
temperature management equipment at the discretion of the trial sites. To
facilitate cooling, when applicable, and to stabilise the circulation all
patients will be treated with 30 ml/kg of crystalloid infusion (4°C or room
temperature according to treatment arm).
Study burden and risks
Standard therapy for patients in coma after cardiopulmonary resuscitation is
24hours hypothermia (33C), but the most effective target temperature is at the
moment uncertain. Known adverse effects of hypothermia treatment are with
infection, coagulopathy, electrolyte disorders and arrhythmia. To enable
treatment with hypothermia the patient has to be sedated thoroughly, which also
has risks. The burden and risk of patients in this study is comparable to the
burden of the standard treatment with hypothermia. Additional test needed for
this study are serum sampling (2) for neuron specific enolase levels and a
return visit to the hospital for follow-up tests.
S Vallgatan 5
S-251 87 Helsingborg
SE
S Vallgatan 5
S-251 87 Helsingborg
SE
Listed location countries
Age
Inclusion criteria
1) Age *18 years,
2) Out of hospital cardiac arrest of presumed cardiac cause,
3) Sustained return of sponteneous circulation (ROSC),
4) Unconsciousness (GCS <8) (patients not able to obey verbal commands) after sustained ROSC.
Exclusion criteria
1. Conscious patients (obeying verbal commands)
2. Pregnancy
3. In-hospital cardiac arrest (IHCA)
4. OHCA of presumed non-cardiac cause, e.g. after trauma or dissection/rupture of major artery OR Cardiac arrest caused by initial hypoxia (i.e. drowning, suffocation, hanging).
5. Known bleeding diathesis (medically induced coagulopathy (e.g. warfarin, clopidogrel) does not exclude the patient).
6. Suspected or confirmed acute intracranial bleeding
7. Suspected or confirmed acute stroke
8. Unwitnessed asystole
9. Known limitations in therapy and Do Not Resuscitate-order
10. Known disease making 180 days survival unlikely
11. Known pre-arrest CPC 3 or 4
12. >4 hours (240 minutes) from ROSC to screening
13. Systolic blood pressure <80 mm Hg in spite of fluid loading/vasopressor and/or inotropic medication/intra aortic balloon pump
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01020916 |
| CCMO | NL32044.018.10 |