Evidence map›Paper›PMID 38191184›Full record

Trial reportStroke and vascular neurology2024

Safety and efficacy of glibenclamide on cerebral oedema following aneurysmal subarachnoid haemorrhage: a randomised, double-blind, placebo-controlled clinical trial.

Xuebing Feng, Tongyu Zhang, Ning Wang, Xin Qu, Meng Qi, Hao Zhao, Hongqi Zhang, Yueqiao Xu

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Stroke and vascular neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
5.5field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Xuebing Feng *Department of Neurosurgery, Xuanwu Hospital Capital Medical University, Beijing, China.
Tongyu Zhang *Department of Neurosurgery, Xuanwu Hospital Capital Medical University, Beijing, China.
Ning WangDepartment of Neurosurgery, Xuanwu Hospital Capital Medical University, Beijing, China.
Xin QuDepartment of Neurosurgery, Xuanwu Hospital Capital Medical University, Beijing, China.
Meng QiDepartment of Neurosurgery, Xuanwu Hospital Capital Medical University, Beijing, China.
Hao ZhaoDepartment of Neurosurgery, Xuanwu Hospital Capital Medical University, Beijing, China.
Hongqi ZhangDepartment of Neurosurgery, Xuanwu Hospital Capital Medical University, Beijing, China xuyueqiao@sina.com xwzhanghq@163.com.ORCID 0000-0001-8740-6828
Yueqiao XuDepartment of Neurosurgery, Xuanwu Hospital Capital Medical University, Beijing, China xuyueqiao@sina.com xwzhanghq@163.com.ORCID 0000-0002-2109-7695
Capital Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGlibenclamide has garnered attention due to its multifaceted neuroprotective effects in cases of acute central nervous system injury. We initiated a trial to explore the effectiveness and safety of a high dose of glibenclamide in the management of cerebral oedema following aneurysmal subarachnoid haemorrhage (aSAH).

methodsThis trial constituted a single-centre, randomised clinical study. Half of the 56 patients assigned to the glibenclamide group received 15 mg of glibenclamide tablets daily for 10 days (5 mg, three times/day). The primary outcome was the proportion of patients achieving the subarachnoid haemorrhage early brain oedema score dichotomy (defined as Subarachnoid Haemorrhage Early Brain Oedema Score 0-2) at the 10-day postmedication. The secondary outcome of cerebral oedema was the concentration of sulfonylurea receptor 1-transient receptor potential melastatin 4 (SUR1-TRPM4) in the plasma and cerebrospinal fluid.

resultsWe enrolled 56 patients diagnosed with aSAH, who were admitted to the neurosurgery intensive care unit between 22 August 2021 and 25 April 2023. The primary outcome revealed that the glibenclamide group exhibited a notably higher proportion of mild cerebral oedema in comparison to the placebo group (60.7% vs 42.9%, adjusted OR: 4.66, 95% CI 1.14 to 19.10, p=0.032). Furthermore, the concentration of SUR1-TRPM4 in the cerebrospinal fluid of the glibenclamide group was significantly higher than the placebo group (p=0.0002; p=0.026), while the plasma TRPM4 concentration in the glibenclamide group was significantly lower than the placebo group (p=0.001).

conclusionOral administration of high-dose glibenclamide notably reduced radiological assessment of cerebral oedema after 10 days of medication. Significant alterations were also observed in the concentration of SUR1-TRPM4 in plasma and cerebrospinal fluid. However, it is worth noting that glibenclamide was associated with a higher incidence of hypoglycaemia. Larger trials are warranted to evaluate the potential benefits of glibenclamide in mitigating swelling and then improving neurological function. TRIAL REGISTRATION NUMBER: ChiCTR2100049908.

Indexed as

Brain EdemaGlyburideSubarachnoid HemorrhageSulfonylurea ReceptorsTRPM Cation ChannelsAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedNeuroprotective AgentsTime FactorsTreatment OutcomeABCC8 protein, humanGlyburideNeuroprotective AgentsSulfonylurea ReceptorsTRPM4 protein, humanTRPM Cation ChannelsAneurysmClinical Trial

Identifiers

PMID38191184
PMCPMC11732842
OpenAlexW4390698540

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.