Goal-directed fluid therapy in emergency abdominal surgery: a randomised multicentre trial
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Goal-directed fluid therapy in emergency abdominal surgery : a randomised multicentre trial. / Aaen, Anne A; Voldby, Anders W; Storm, Nicolas; Kildsig, Jeppe; Hansen, Egon G; Zimmermann-Nielsen, Erik; Jensen, Kenneth M; Tibæk, Pernille; Mortensen, Anette; Møller, Ann M; Brandstrup, Birgitte.
In: British Journal of Anaesthesia, Vol. 127, No. 4, 2021, p. 521-531.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Goal-directed fluid therapy in emergency abdominal surgery
T2 - a randomised multicentre trial
AU - Aaen, Anne A
AU - Voldby, Anders W
AU - Storm, Nicolas
AU - Kildsig, Jeppe
AU - Hansen, Egon G
AU - Zimmermann-Nielsen, Erik
AU - Jensen, Kenneth M
AU - Tibæk, Pernille
AU - Mortensen, Anette
AU - Møller, Ann M
AU - Brandstrup, Birgitte
N1 - Copyright © 2021 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.
PY - 2021
Y1 - 2021
N2 - BACKGROUND: More than 50% of patients have a major complication after emergency gastrointestinal surgery. Intravenous (i.v.) fluid therapy is a life-saving part of treatment, but evidence to guide what i.v. fluid strategy results in the best outcome is lacking. We hypothesised that goal-directed fluid therapy during surgery (GDT group) reduces the risk of major complications or death in patients undergoing major emergency gastrointestinal surgery compared with standard i.v. fluid therapy (STD group).METHODS: In a randomised, assessor-blinded, two-arm, multicentre trial, we included 312 adult patients with gastrointestinal obstruction or perforation. Patients in the GDT group received i.v. fluid to near-maximal stroke volume. Patients in the STD group received i.v. fluid following best clinical practice. Postoperative target was 0-2 L fluid balance. The primary outcome was a composite of major complications or death within 90 days. Secondary outcomes were time in intensive care, time on ventilator, time in dialysis, hospital stay, and minor complications.RESULTS: In a modified intention-to-treat analysis, we found no difference in the primary outcome between groups: 45 (30%) (GDT group) vs 39 (25%) (STD group) (odds ratio=1.24; 95% confidence interval, 0.75-2.05; P=0.40). Hospital stay was longer in the GDT group: median (inter-quartile range), 7 (4-12) vs 6 days (4-8.5) (P=0.04); no other differences were found.CONCLUSION: Compared with pressure-guided i.v. fluid therapy (STD group), flow-guided fluid therapy to near-maximal stroke volume (GDT group) did not improve the outcome after surgery for bowel obstruction or gastrointestinal perforation but may have prolonged hospital stay.CLINICAL TRIAL REGISTRATION: EudraCT number 2015-000563-14; the Danish Scientific Ethics Committee and the Danish Data Protection Agency (REG-18-2015).
AB - BACKGROUND: More than 50% of patients have a major complication after emergency gastrointestinal surgery. Intravenous (i.v.) fluid therapy is a life-saving part of treatment, but evidence to guide what i.v. fluid strategy results in the best outcome is lacking. We hypothesised that goal-directed fluid therapy during surgery (GDT group) reduces the risk of major complications or death in patients undergoing major emergency gastrointestinal surgery compared with standard i.v. fluid therapy (STD group).METHODS: In a randomised, assessor-blinded, two-arm, multicentre trial, we included 312 adult patients with gastrointestinal obstruction or perforation. Patients in the GDT group received i.v. fluid to near-maximal stroke volume. Patients in the STD group received i.v. fluid following best clinical practice. Postoperative target was 0-2 L fluid balance. The primary outcome was a composite of major complications or death within 90 days. Secondary outcomes were time in intensive care, time on ventilator, time in dialysis, hospital stay, and minor complications.RESULTS: In a modified intention-to-treat analysis, we found no difference in the primary outcome between groups: 45 (30%) (GDT group) vs 39 (25%) (STD group) (odds ratio=1.24; 95% confidence interval, 0.75-2.05; P=0.40). Hospital stay was longer in the GDT group: median (inter-quartile range), 7 (4-12) vs 6 days (4-8.5) (P=0.04); no other differences were found.CONCLUSION: Compared with pressure-guided i.v. fluid therapy (STD group), flow-guided fluid therapy to near-maximal stroke volume (GDT group) did not improve the outcome after surgery for bowel obstruction or gastrointestinal perforation but may have prolonged hospital stay.CLINICAL TRIAL REGISTRATION: EudraCT number 2015-000563-14; the Danish Scientific Ethics Committee and the Danish Data Protection Agency (REG-18-2015).
KW - Abdomen/surgery
KW - Aged
KW - Critical Care/statistics & numerical data
KW - Digestive System Surgical Procedures/methods
KW - Female
KW - Fluid Therapy/methods
KW - Goals
KW - Humans
KW - Length of Stay/statistics & numerical data
KW - Male
KW - Middle Aged
KW - Postoperative Complications/epidemiology
KW - Stroke Volume
KW - Water-Electrolyte Balance
U2 - 10.1016/j.bja.2021.06.031
DO - 10.1016/j.bja.2021.06.031
M3 - Journal article
C2 - 34389168
VL - 127
SP - 521
EP - 531
JO - British Journal of Anaesthesia
JF - British Journal of Anaesthesia
SN - 0007-0912
IS - 4
ER -
ID: 298129813