Dataset Information

Targeted temperature management at 33 degrees Celsius in patients with high-grade aneurysmal subarachnoid hemorrhage: a protocol for a multicenter randomized controlled study.

ABSTRACT:

Background

Studies on the use of therapeutic hypothermia (TH) to improve the outcome of high-grade aneurysmal subarachnoid hemorrhage (aSAH), show promising, though conflicting results because of the lack of high-quality trials. The aim of this study is to evaluate the safety and efficacy of TH (maintaining bladder temperature at 33 °C for ≥72 h) to treat patients with high-grade aSAH (Hunt-Hess grade IV-V).

Methods

A multicenter, randomized, controlled clinical trial will be conducted for October 2020 to September 2024 involving 10 clinics. Patients who meet the inclusion criteria will be randomized 1:1 to a TH group and a normothermia group. The trial will enroll 96 participants in TH group and normothermia one, respectively. The trial was registered with ClinicalTrials.gov (NCT03442608) on February 22, 2018. Following conventional treatment for aSAH, patients will undergo either TH for at least 72 h or normothermia. The primary endpoint is the Glasgow outcome scale at 6 months after bleeding. The secondary endpoints are: (I) mortality at 6 months after bleeding; (II) intracranial pressure; (III) intensive care unit stay; and (IV) hospital stay. The safety endpoints include neurological, infectious, intestinal, circulatory, coagulation, and bleeding complications, electrolyte disorders, and other complications.

Discussion

If the study hypothesis is confirmed, TH at 33 °C in patients with high-grade aSAH may become a promising treatment strategy for improving 6-month outcome.

Trial registration

The trial has been registered at ClinicalTrials.gov (ID: NCT03442608).

SUBMITTER: Qu X

PROVIDER: S-EPMC8105800 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe aim was to study the course of body temperature in the acute phase of poor-grade aneurysmal subarachnoid hemorrhage (aSAH) in relation to the primary brain injury, cerebral physiology, and clinical outcome.MethodsIn this observational study, 166 patients with aSAH treated at the neurosurgery department at Uppsala University Hospital in Sweden between 2008 and2018 with temperature, intracranial pressure (ICP), and microdialysis (MD) monitoring were included. The first 10 days were divided into the early phase (days 1-3) and the vasospasm phase (days 4-10).ResultsNormothermia (temperature = 36-38 °C) was most prevalent in the early phase. A lower mean temperature at this stage was univariately associated with a worse primary brain injury, with higher Fisher grade and higher MD glycerol concentration, as well as a worse neurological recovery at 1 year. There was otherwise no association between temperature and cerebral physiological variables in the early phase. There was a transition toward an increased burden of hyperthermia (temperature > 38 °C) in the vasospasm phase. This was associated with concurrent infections but not with neurological or radiological injury severity at admission. Elevated temperature was associated with higher MD pyruvate concentration, lower rate of an MD pattern indicative of ischemia, and higher rate of poor neurological recovery at 1 year. There was otherwise no association between temperature and cerebral physiological variables in the vasospasm phase. The associations between temperature and clinical outcome did not hold true in multiple logistic regression analyses.ConclusionsSpontaneously low temperature in the early phase reflected a worse primary brain injury and indicated a worse outcome prognosis. Hyperthermia was common in the vasospasm phase and was more related to infections than primary injury severity but also with a more favorable energy metabolic pattern with better substrate supply, possibly related to hyperemia.