Nijasri C Suwanwela1, Aurauma Chutinet2, Seangduan Mayotarn3, Ratchayut Thanapiyachaikul2, Napasri Chaisinanunkul2, Thanin Asawavichienjinda4, Sombat Muengtaweepongsa5, Yongchai Nilanont6, Jitlada Samajarn2, Kanokwan Watcharasaksilp7, Somsak Tiamkao8, Pakkawan Vongvasinkul2, Supparat Charnwut2, Jeffrey L Saver9. 1. Division of Neurology, Department of Medicine, Chulalongkorn University, Rama IV Road, Bangkok, 10330, Thailand. Electronic address: nijasris@yahoo.com. 2. Chulalongkorn Stroke Center, King Chulalongkorn Memorial Hospital, Bangkok, Thailand. 3. Division of Neurology, Department of Medicine, Bhumibol Adulyadej Hospital, Bangkok, Thailand. 4. Division of Clinical Epidemiology, Department of Medicine, Chulalongkorn University, Bangkok, Thailand. 5. Division of Neurology, Department of Medicine, Thammasat University, Pathumtani, Thailand. 6. Division of Neurology, Department of Medicine, Siriraj Hospital, Thailand. 7. Division of Neurology, Department of Medicine, Chiang mai University, Chiang mai, Thailand. 8. Division of Neurology, Department of Medicine, Khon kaen Univerisity, Khon kaen, Thailand. 9. Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine, University of California, Los Angeles, CA, United States.
Abstract
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.
RCT Entities:
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 strokepatients 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 strokepatients with NIHSS less than 18 who have no contraindications.