NS-STROKE Trial

Normal Saline Infusion for Stroke after Intravenous Thrombolysis
We evaluated the efficacy and safety of immediate and abundant normal saline infusion after intravenous thrombolysis in promoting functional independence in patients with acute ischemic stroke.
Participants were assigned to either the normal saline or control group. In the normal saline group, patients received a 2000 mL normal saline intravenous infusion at 200 mL/h following IVT. In the control group, patients received 200–400 mL of normal saline after IVT.
The primary efficacy outcome was functional independence at 90 days, which was assessed using the mRS, an ordinal global disability scale ranging from 0 (no symptoms) to 6 (death). Outcomes were dichotomized as favorable (a score of 0–2) or unfavorable (a score of 3–6), in accordance with the Cochrane analysis of thrombolysis in stroke. Secondary efficacy outcomes included early neurological deterioration (END) within 24 hours after randomization; cerebrovascular events within 24 hours, 7 days, and 3 months; NIHSS scores at 24 hours and 7 days; mRS scores at 7 days and 1 month; and the Barthel Index at 1 and 3 months. END was defined as a worsening of NIHSS by ≥2 or ≥4 scores within 24 hours after IVT, not attributable to intracranial hemorrhage, as confirmed by cranial CT. Cerebrovascular events included progressive stroke (NIHSS worsening by ≥2 scores), transient ischemic attack (TIA), or new ischemic lesions confirmed by imaging tests. Laboratory tests were S100-β, brain-derived neurotrophic factor (BDNF), and myeloperoxidase (MPO) within 24–48 hours. Follow-ups were performed at 30 and 90 days through structured telephone interviews by personnel certified in scoring the mRS and Barthel Index.
The safety endpoints included left ventricular ejection fraction assessed via ultrasonography within 72 hours after randomization, 90-day mortality, blood pressure within 24 hours, infarction volume at 24 hours, incidence of symptomatic intracranial hemorrhage (defined as NIHSS worsening by ≥2 points in combination with intracranial hemorrhage on CT scans without attributable causes), and any intracranial hemorrhage within 7 days.
The NS-STROKE trial showed that early administration of abundant ntravenous normal saline in patients with acute ischemic stroke treated with intravenous thrombolysis improved 90-day outcomes but without increasing the risk of death or heart dysfunction.
The dataset includes ID data of patients from initial visit, intervention data, data from visit after 24 hours, 7 days, 30 days and 90 days.