Win Sen Kuan1, Irwani Ibrahim2, Benjamin S H Leong2, Swati Jain3, Qingshu Lu4, Yin Bun Cheung5, Malcolm Mahadevan2. 1. Emergency Medicine Department, National University Hospital, National University Health System, Singapore and the Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Centre for Quantitative Medicine, Duke-NUS Graduate Medicine School, Singapore. Electronic address: win_sen_kuan@nuhs.edu.sg. 2. Emergency Medicine Department, National University Hospital, National University Health System, Singapore and the Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. 3. Centre for Quantitative Medicine, Duke-NUS Graduate Medicine School, Singapore. 4. Centre for Quantitative Medicine, Duke-NUS Graduate Medicine School, Singapore; Singapore Clinical Research Institute, Singapore. 5. Centre for Quantitative Medicine, Duke-NUS Graduate Medicine School, Singapore; Department of International Health, University of Tampere, Tampere, Finland.
Abstract
STUDY OBJECTIVE: The noninvasive cardiac output monitor and passive leg-raising maneuver has been shown to be reasonably accurate in predicting fluid responsiveness in critically ill patients. We examine whether using a noninvasive protocol would result in more rapid lactate clearance after 3 hours in patients with severe sepsis and septic shock in the emergency department. METHODS: In this open-label randomized controlled trial, 122 adult patients with sepsis and serum lactate concentration of greater than or equal to 3.0 mmol/L were randomized to receive usual care or intravenous fluid bolus administration guided by measurements of change of stroke volume index, using the noninvasive cardiac output monitor after passive leg-raising maneuver. The primary outcome was lactate clearance of more than 20% at 3 hours. Secondary outcomes included mortality, length of hospital and ICU stay, and total hospital cost. Analysis was intention to treat. RESULTS: Similar proportions of patients in the randomized intervention group (70.5%; N=61) versus control group (73.8%; N=61) achieved the primary outcome, with a relative risk of 0.96 (95% confidence interval [CI] 0.77 to 1.19). Secondary outcomes were similar in both groups (P>.05 for all comparisons). Hospital mortality occurred in 6 patients (9.8%) each in the intervention and control groups on or before 28 days (relative risk=1.00; 95% CI 0.34 to 2.93). Among a subgroup of patients with underlying fluid overload states, those in the intervention group tended to receive clinically significantly more intravenous fluids at 3 hours (difference=975 mL; 95% CI -450 to 1,725 mL) and attained better lactate clearance (difference=19.7%; 95% CI -34.6% to 60.2%) compared with the control group, with shorter hospital lengths of stay (difference=-4.5 days; 95% CI -9.5 to 2.5 days). CONCLUSION:Protocol-based fluid resuscitation of patients with severe sepsis and septic shock with thenoninvasive cardiac output monitor and passive leg-raising maneuver did not result in better outcomes compared with usual care. Future studies to demonstrate the use of the noninvasive protocol-based care in patients with preexisting fluid overload states may be warranted.
RCT Entities:
STUDY OBJECTIVE: The noninvasive cardiac output monitor and passive leg-raising maneuver has been shown to be reasonably accurate in predicting fluid responsiveness in critically illpatients. We examine whether using a noninvasive protocol would result in more rapid lactate clearance after 3 hours in patients with severe sepsis and septic shock in the emergency department. METHODS: In this open-label randomized controlled trial, 122 adult patients with sepsis and serum lactate concentration of greater than or equal to 3.0 mmol/L were randomized to receive usual care or intravenous fluid bolus administration guided by measurements of change of stroke volume index, using the noninvasive cardiac output monitor after passive leg-raising maneuver. The primary outcome was lactate clearance of more than 20% at 3 hours. Secondary outcomes included mortality, length of hospital and ICU stay, and total hospital cost. Analysis was intention to treat. RESULTS: Similar proportions of patients in the randomized intervention group (70.5%; N=61) versus control group (73.8%; N=61) achieved the primary outcome, with a relative risk of 0.96 (95% confidence interval [CI] 0.77 to 1.19). Secondary outcomes were similar in both groups (P>.05 for all comparisons). Hospital mortality occurred in 6 patients (9.8%) each in the intervention and control groups on or before 28 days (relative risk=1.00; 95% CI 0.34 to 2.93). Among a subgroup of patients with underlying fluid overload states, those in the intervention group tended to receive clinically significantly more intravenous fluids at 3 hours (difference=975 mL; 95% CI -450 to 1,725 mL) and attained better lactate clearance (difference=19.7%; 95% CI -34.6% to 60.2%) compared with the control group, with shorter hospital lengths of stay (difference=-4.5 days; 95% CI -9.5 to 2.5 days). CONCLUSION: Protocol-based fluid resuscitation of patients with severe sepsis and septic shock with the noninvasive cardiac output monitor and passive leg-raising maneuver did not result in better outcomes compared with usual care. Future studies to demonstrate the use of the noninvasive protocol-based care in patients with preexisting fluid overload states may be warranted.
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