Normal Saline Infusion for Stroke After Intravenous Thrombolysis
Status:
Recruiting
Trial end date:
2025-06-30
Target enrollment:
Participant gender:
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 NS group and control group randomly after confirming as
acute ischemic stroke (AIS) according to symptoms and signs. In NS group, the patient will
undergo NS 2000ml intravenous infusion swiftly after IVT, with the speed of 200ml/h. In
control group, the patient will not undergo NS intravenous infusion 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 or 1), or an unfavorable outcome (a score
of 2 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. Stata 15.1 and R
software will be used for statistical analysis