Normal Saline Infusion for Stroke After Intravenous Thrombolysis

Phase 2

Completed

Conditions: Brain Infarct

Interventions: Drug: 0.9% NaCl 2000ml
Drug: 0.9% NaCl 200-400ml

Registration Number: NCT05993078

Lead Sponsor: Tianjin Medical University General Hospital

Brief Summary: This study aims to explore the safety and efficacy of 0.9% normal saline （NS） infusion on stroke after intravenous thrombolysis (IVT), we decided to conduct this multi-centre randomized controlled trial for the first time. This trial will provide an innovative strategy to facilitate functional independence after stroke administered with IVT. This is a multi-center, randomized controlled two arm (1:1 ratio) clinical trial. The enrolled participators will be divided into the NS group and the control group randomly after confirming as acute ischemic stroke (AIS). In the NS group, the patient will undergo NS 2000ml intravenous infusion immediately after IVT, with the speed of 200ml/h. In the control group, the patient will receive an NS 200-400ml after IVT. The primary efficacy is disability at days 90, as scored by means of the modified Rankin scale (mRS), dichotomized as a favorable outcome (a score of 0-2), or an unfavorable outcome (a score of 3 to 6). The secondary outcomes mainly comprise neurological deficits, disability, imaging and laboratory tests at each follow-up time. The safety outcomes include the cerebral edema at 24-hour post-IVT detected by cranial CT, the 24-hour fluctuation of blood pressure and the cardiac function detected by ultrasonic cardiogram within 3 days after IVT.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 241

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NS group	0.9% NaCl 2000ml	The patient will undergo NS 2000ml intravenous infusion immediately after IVT.
Control group	0.9% NaCl 200-400ml	The patient will the patients receive an NS 200-400ml after IVT.

Primary Outcome Measures

Name	Time	Method
Number of Participants With 90-day Favorable Outcome	90 days	Disability on day 90, as scored by means of the modified Rankin scale (mRS), dichotomized as a favorable outcome (a score of 0 to 2), or an unfavorable outcome (a score of 3 to 6). Scores on mRS range from 0 (no symptoms at all) to 6 (death), with higher values reflecting more severe disability or death.

Secondary Outcome Measures

Name	Time	Method
NIHSS Scores at 24 Hours	24 hours	The National Institutes of Health Stroke Scale (NIHSS), a 15-item scale that measures the level of neurologic impairment. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts (\<5, mild impairment; ≥25, very severe neurologic impairment).
NIHSS Scores on Day 7	7 days	The National Institutes of Health Stroke Scale (NIHSS), a 15-item scale that measures the level of neurologic impairment. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts (\<5, mild impairment; ≥25, very severe neurologic impairment).
mRS on Day 7	7 days	Scores on the modified Rankin scale(mRS) range from 0 (no symptoms at all) to 6 (death), with higher values reflecting more severe disability or death.
mRS on Day 30	30 days	Scores on the modified Rankin scale(mRS) range from 0 (no symptoms at all) to 6 (death), with higher values reflecting more severe disability or death.
Number of Participants With Barthel Index 60-100 on Day 30	30 days	The Barthel Index represents functional status at follow-up time, the scores of which range from 0 (complete dependence) to 100 (complete independence) measured by several items, including feeding, bathing, grooming, dressing, bowels, bladder, toilet use, transfers, and stairs.
Number of Participants With Barthel Index 60-100 on Day 90	90 days	The Barthel Index represents functional status at follow-up time, the scores of which range from 0 (complete dependence) to 100 (complete independence) measured by several items, including feeding, bathing, grooming, dressing, bowels, bladder, toilet use, transfers, and stairs.
Number of Pariticipants With Early Neurological Deterioration (END, △NIHSS≥2)	24 hours	Early neurological deterioration (END) indicates an increase of ≥2 in the NIHSS score within 24 hours after IVT, and the deterioration is not caused by intracranial hemorrhage that is confirmed by cranial CT. The National Institutes of Health Stroke Scale (NIHSS), a 15-item scale that measures the level of neurologic impairment. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts.
Number of Participants With Early Neurological Deterioration (END, △NIHSS≥4)	24 hours	Early neurological deterioration (END) indicates an increase of ≥4 in the NIHSS score within 24 hours after IVT, and the deterioration is not caused by intracranial hemorrhage that is confirmed by cranial CT. The National Institutes of Health Stroke Scale (NIHSS), a 15-item scale that measures the level of neurologic impairment. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts.
Imaging Infarction Volume at 24 Hours	24 hours	Cranial computed tomography (CT) scans are performed before IVT and 24 hours after randomization. The infarction area is confirmed using CT maps and the infarction volume is calculated by 3D-Slicer (Version4.6.2, https://www.slicer.org/).
Blood Pressure at 24 Hours	24 hours	Blood pressure, including systolic blood pressure (SBP) and diastolic blood pressure (DBP), is monitored at 24 hours after randomization.
Ejection Fraction	72 hours	Ejection fraction was assessed by ultrasonic cardiogram within 72 hours after randomization.
Death Rate	90 days	Death rate within 90 days after randomization.
Number of Paricipants With Intracaranial Hemorrhage	7 days	Intracaranial hemorrhage confirmed by cranial CT within 7 days after randomization.
Number of Participants With Symptomatic Intracranial Hemorrhage	7 days	Symptomatic intracranial hemorrhage indicates NIHSS deterioration≥2 scores in combination with intracranial hemorrhage on CT scan without other causes for the deterioration within 7 days after randomization.
Neutrophil-to-lymphocyte Ratio (NLR)	24-48 hours	Peripheral blood inflammatory indices, neutrophil-to-lymphocyte ratio (NLR),24-48 hours after randomization.
Platelet-to-lymphocyte (PLR)	24-48 hours	Peripheral blood inflammatory indices, platelet-to-lymphocyte (PLR) at 24-48 hours after randomization.
SII	24-48 hours	Peripheral blood inflammatory indices, (platelet✖neurophil)/lymphocyte (SII) at 24-48 hours after randomization.
S100-β	24-48 hours	Laboratory examinations, peripehral S100-β at 24-48 hours after randomization.
Myeloperoxidase (MPO)	24-48 hours	Laboratory examinations, peripheral myeloperoxidase (MPO) at 24-48 hours after randomization.
Brain Derived Neurotrophic Factor (BDNF)	24-48 hours	Laboratory examinations, brain derived neurotrophic factor (BDNF)at 24-48 hours after randomization.

Trial Locations

Locations (3): Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province
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Cangzhou, Heibei, China
Affiliated Hospital of Jiujiang University
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Jiujiang, Jiangxi, China
Tianjin Medical University General Hospital
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Tianjin, Tianjin, China