Gastrointestinal Decompression in Stroke

Not Applicable

Not yet recruiting

• Conditions: Stomach Acidity; Gastrointestinal Decompression; Stroke; Pulmonary Infection
• Interventions: Procedure: Control; Procedure: Gastrointestinal decompression

• Registration Number: NCT06214091
• Lead Sponsor: Tianjin Medical University General Hospital

Brief Summary

Acute severe ischemic stroke is a life-threatening subtype of stroke. Due to stress ulcer and gastric reflux in acute stage, patients with severe ischemic stroke are always complicated with stomach bleeding and pulmonary infections, resulting in poor prognosis and even death. Reducing stomach acidity and avoiding gastric reflux play a pivotal role on controlling serious complications after austere ischemic attack. Gastrointestinal decompression is an cheap, safe, effective and acknowledgemented strategy for treating stomach bleeding and preventing gastric reflux in clinical settings. Early gastrointestinal decompression seems to be an available method to reduce stomach acidity and avoid gastric reflux after severe ischemic stroke. Therefore, we aimed to evaluate the safety and efficacy of early gastrointestinal decompression in patients with acute severe ischemic stroke.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-18
• Study First Posted: 2024-01-19
• Last Update Posted: 2024-01-22
• Study Start: 2024-02-01
• Primary Completion: 2025-02-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age 18-80 years
• severe AIS, including NIHSS score>20 in dominant hemisphere infarction, or NIHSS score>15 in non-dominant hemisphere infarction, or NIHSS consciousness score >1; · massive infarction, characterized by infarction area larger than 1/3 of the effected middle cerebral artery territory and/or the cerebellum territory presented in admitted computed tomography (CT) or MRI
• onset-to-needle time within 24 hours
• prestroke modified Ranking scales (mRS)≤1
• sign the informed consent.

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Exclusion Criteria

• Recent respiratory infection and/or gastrointestinal bleeding
• austere diseases such as tumors and dyscrasia
• intention to undergo emergency thrombectomy
• pregnant women or nursing mother
• contraindication for gastric tubes
• participating in other clinical trials within previous 3 months.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control	-
Gastrointestinal decompression group	Gastrointestinal decompression	-

Primary Outcome Measures

Name	Time	Method
90-day Death	90 days	Death rate at 90 days

Secondary Outcome Measures

Name	Time	Method
90-day mRS	90 days	mRS at 90 days
30-day mRS	30 days	mRS at 30 days
30-day Barthel scores	30 days	Barthel scores at 30 days
90-day Barthel scores	90 days	Barthel scores at 90 days