The objective of this study is to assess if 1) by using the Arctic Sun® 5000 Temperature Management System occurrence of fever can be prevented and 2) patients treated with the Arctic Sun® 5000 Temperature Management System have a better recovery…
ID
Source
Brief title
Condition
- Vascular haemorrhagic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome endpoint is the daily average fever burden (°C-hour)
between randomization and Day 14 (336 hours) or ICU exit, whichever comes
first.
The key secondary outcome endpoint (to which the study was powered) is the
level of functional independence at 90 days post-injury (3-month) follow-up
based on the modified Rankin Scale.
Secondary outcome
* Neurologic outcome measures
- Modified Rankin Scale measured at 6- and 12-months
- National Institutes of Health Stroke Scale measured at 3- and 6-months
- Barthel Index measured at 3- and 6-months
- Glasgow Outcome Scale Extended measured at 3- and 6-months
- Montreal Cognitive Assessment measured at 3- and 6-months
* Intensive Care Unit length of stay
* ICU Delirium
* Use of mechanical ventilation
* Hospital length of stay
* Mortality [7-day (or hospital discharge), 3-, 6-, and 12-month]
Background summary
Multiple studies demonstrate that fever or elevated body temperature is
associated with poor outcomes in brain injured patients; however, there are no
conclusive studies that demonstrate that fever prevention/controlled
normothermia is associated with better outcomes. This study will be conducted
to assess the impact of advanced temperature control to prevent fever in brain
injured patients.
Study objective
The objective of this study is to assess if 1) by using the Arctic Sun® 5000
Temperature Management System occurrence of fever can be prevented and 2)
patients treated with the Arctic Sun® 5000 Temperature Management System have a
better recovery and neurological outcome compared to patients where this device
has not been used and fever has not been prevented.
Study design
This is a randomized, controlled multicenter clinical investigation designed to
assess fever burden and early, short- and long-term clinical outcomes of fever
prevention using the Arctic Sun 5000 Temperature Management System (test
device) compared to standard fever care in the treatment of moderate-to-severe
brain injured patients.
Treatment Arms:
Fever Prevention Group * Subjects randomized to the "fever prevention group"
will be treated with the Arctic Sun® 5000 Temperature Management System in
order to maintain normothermia (target temperature 37°C). Normothermia will be
maintained through day 14 of the study or until the subject is discharged from
the ICU, whichever comes first.
Control Group * In subjects randomized to the "control group", fever may or may
not develop. Should fever develop, it will be managed according to a standard,
escalating treatment algorithm. Subjects will be treated according to the
protocol through day 14 of the study or until the subject is discharged from
the ICU, whichever comes first.
Intervention
See study design
Study burden and risks
Patients will be followed up at the following time points:
- 5 days after the acute phase or at hospital discharge, whichever comes first
- 3 months after their brain injury
- 6 months after their brain injury
- 12 months after their brain injury (this visit may be over the phone)
During the follow up visits several standard neurologic assessments will be
performed.
Hagelberg 2
Olen 2250
BE
Hagelberg 2
Olen 2250
BE
Listed location countries
Age
Inclusion criteria
* Adult patients ><=18 and <<=85 years of age (for patients >80 and <<=85 years of age, the qualifying mRS must be <= 0)
* Admitted with a primary neurological diagnosis of ischemic stroke (AIS), intracerebral hemorrhage (ICH), or subarachnoid hemorrhage (SAH)
* Prior to onset of acute symptoms, was considered functionally independent (mRS 0-2)
* Disease-specific criteria:
For AIS patients:
- imaging confirmed diagnosis
- NIHSS ><= 6 at the time of consideration of enrollment
For ICH patients:
- imaging confirmed diagnosis
- NIHSS ><= 6 at the time of consideration of enrollment
- GCS ><= 5 at the time of consideration of enrollment
- ICH volume of 1-60 cc
For SAH patients:
- aneurysmal SAH confirmed within 24 hrs of symptom onset
- admission imaging shows Fisher Grade 2, 3 or 4
- WFNS Grade II-IV
- neurological stability within 6-48 hrs of endovascular or surgical procedure (if performed)
Exclusion criteria
* Fever (>= 38°C) for more than one hour prior to study enrollment
* Pre-existing neurological, psychiatric, or other condition that would confound neurological assessment or would make it difficult to accurately assess neurologic and/or functional outcome
* Has a pre-morbid condition that in the opinion of the investigator suggests poor likelihood of survival to 6 months
* Is undergoing therapeutic hypothermia therapy
* Has sustained neurological injury felt to be catastrophic with little chance of recovery or is on comfort measures only
* Has a skin condition in which the use of the ArcticGel Pads is contraindicated
* Participation in a concurrent interventional study
* In the investigator*s opinion is likely to stay in the ICU <= 72 hours
* Is known to be pregnant
* fever (>= 38°C) at time of study enrollment
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NCT02996266 |
| CCMO | NL62306.098.17 |