A randomized controlled study of intravenous fluid in acute ischemic stroke.

OBJECTIVE To compare the outcome of patients with acute ischemic stroke who received or did not receive intravenous fluid. PATIENTS AND METHODS This study was a prospective, multicenter, randomized, open-label trial with blinded outcome assessment. We enrolled acute ischemic stroke patients without dehydration aged between 18 and 85 years with NIH Stroke Scale score (NIHSS) score from 1 to 18 who presented within 72h after onset. Patients were randomly assigned to receive 0.9% NaCl solution 100ml/h for 3days or no intravenous fluid. RESULTS On the interim unblinded analysis of the safety data, significant excess early neurological deterioration was observed among patients in the non-intravenous fluid group. Therefore, the study was prematurely discontinued after enrollment of 120 patients, mean age 60 years, 56.6% male. Early neurological deterioration (increased NIHSS ≥3 over 72h) not of metabolic or hemorrhagic origin was observed in 15% of the non-IV fluid group and 3.3% of the IV fluid group (p=0.02). Predictors of neurological deterioration were higher NIHSS score, higher plasma glucose, and increased pulse rate. There was no difference in the primary efficacy outcome, NIHSS≤4 at day 7, 83.3% vs 86.7%, p=0.61 or secondary efficacy outcomes. CONCLUSION Administration of 0.9% NaCl 100ml/h for 72h in patients with acute ischemic stroke is safe and may be associated with a reduced risk of neurological deterioration. These study findings support the use of intravenous fluid in acute ischemic stroke patients with NIHSS less than 18 who have no contraindications.