A randomized controlled study of intravenous fluid in acute ischemic stroke

© 2017 Elsevier B.V. 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 str...

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Main Authors: Nijasri C. Suwanwela, Aurauma Chutinet, Seangduan Mayotarn, Ratchayut Thanapiyachaikul, Napasri Chaisinanunkul, Thanin Asawavichienjinda, Sombat Muengtaweepongsa, Yongchai Nilanont, Jitlada Samajarn, Kanokwan Watcharasaksilp, Somsak Tiamkao, Pakkawan Vongvasinkul, Supparat Charnwut, Jeffrey L. Saver
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Published: 2018
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http://cmuir.cmu.ac.th/jspui/handle/6653943832/47052
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spelling th-cmuir.6653943832-470522018-04-25T07:20:12Z A randomized controlled study of intravenous fluid in acute ischemic stroke Nijasri C. Suwanwela Aurauma Chutinet Seangduan Mayotarn Ratchayut Thanapiyachaikul Napasri Chaisinanunkul Thanin Asawavichienjinda Sombat Muengtaweepongsa Yongchai Nilanont Jitlada Samajarn Kanokwan Watcharasaksilp Somsak Tiamkao Pakkawan Vongvasinkul Supparat Charnwut Jeffrey L. Saver Agricultural and Biological Sciences © 2017 Elsevier B.V. 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 72 h after onset. Patients were randomly assigned to receive 0.9% NaCl solution 100 ml/h for 3 days 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 72 h) 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 100 ml/h for 72 h 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. 2018-04-25T07:16:17Z 2018-04-25T07:16:17Z 2017-10-01 Journal 18726968 03038467 2-s2.0-85028543901 10.1016/j.clineuro.2017.08.012 https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85028543901&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/47052
institution Chiang Mai University
building Chiang Mai University Library
country Thailand
collection CMU Intellectual Repository
topic Agricultural and Biological Sciences
spellingShingle Agricultural and Biological Sciences
Nijasri C. Suwanwela
Aurauma Chutinet
Seangduan Mayotarn
Ratchayut Thanapiyachaikul
Napasri Chaisinanunkul
Thanin Asawavichienjinda
Sombat Muengtaweepongsa
Yongchai Nilanont
Jitlada Samajarn
Kanokwan Watcharasaksilp
Somsak Tiamkao
Pakkawan Vongvasinkul
Supparat Charnwut
Jeffrey L. Saver
A randomized controlled study of intravenous fluid in acute ischemic stroke
description © 2017 Elsevier B.V. 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 72 h after onset. Patients were randomly assigned to receive 0.9% NaCl solution 100 ml/h for 3 days 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 72 h) 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 100 ml/h for 72 h 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.
format Journal
author Nijasri C. Suwanwela
Aurauma Chutinet
Seangduan Mayotarn
Ratchayut Thanapiyachaikul
Napasri Chaisinanunkul
Thanin Asawavichienjinda
Sombat Muengtaweepongsa
Yongchai Nilanont
Jitlada Samajarn
Kanokwan Watcharasaksilp
Somsak Tiamkao
Pakkawan Vongvasinkul
Supparat Charnwut
Jeffrey L. Saver
author_facet Nijasri C. Suwanwela
Aurauma Chutinet
Seangduan Mayotarn
Ratchayut Thanapiyachaikul
Napasri Chaisinanunkul
Thanin Asawavichienjinda
Sombat Muengtaweepongsa
Yongchai Nilanont
Jitlada Samajarn
Kanokwan Watcharasaksilp
Somsak Tiamkao
Pakkawan Vongvasinkul
Supparat Charnwut
Jeffrey L. Saver
author_sort Nijasri C. Suwanwela
title A randomized controlled study of intravenous fluid in acute ischemic stroke
title_short A randomized controlled study of intravenous fluid in acute ischemic stroke
title_full A randomized controlled study of intravenous fluid in acute ischemic stroke
title_fullStr A randomized controlled study of intravenous fluid in acute ischemic stroke
title_full_unstemmed A randomized controlled study of intravenous fluid in acute ischemic stroke
title_sort randomized controlled study of intravenous fluid in acute ischemic stroke
publishDate 2018
url https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85028543901&origin=inward
http://cmuir.cmu.ac.th/jspui/handle/6653943832/47052
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