TY - JOUR
T1 - Goal-directed fluid therapy vs. low central venous pressure during major open liver resections (GALILEO): a surgeon- and patient-blinded randomized controlled trial
AU - Jongerius, Iris M.
AU - Mungroop, Timothy H.
AU - Uz, Z. hre
AU - Geerts, Bart F.
AU - Immink, Rogier V.
AU - Rutten, Martin V. H.
AU - Hollmann, Markus W.
AU - van Gulik, Thomas M.
AU - Besselink, Marc G.
AU - Veelo, Denise P.
N1 - Funding Information: Departmental sources of the Amsterdam UMC, University of Amsterdam.Two authors (BG and DV) received research grants and consultancy fees from Edwards Lifesciences, United States and Philips, the Netherlands. Both companies sell advanced monitoring tools that can facilitate GDFT. To the best of our knowledge, no other conflict of interest of influence for this paper exists. Publisher Copyright: © 2021 The Authors Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/10
Y1 - 2021/10
N2 - Background: Low central venous pressure (low-CVP) is the clinical standard for fluid therapy during major liver surgery. Although goal-directed fluid therapy (GDFT) has been associated with reduced morbidity and mortality in major abdominal surgery, concerns remain on blood loss when applying GDFT in liver surgery. This randomized trial compared outcomes of low-CVP and GDFT during major liver resections. Methods: In this surgeon- and patient-blinded RCT, patients undergoing major open liver resections (≥3 segments) were randomized between low-CVP (n = 20) or GDFT (n = 20). Primary outcome was intraoperative blood loss. Secondary outcomes included the quality of the surgical field (VAS scale 0 (worst)-100 (best)) and major morbidity (≥grade 3 Clavien-Dindo). Results: During surgery, CVP was 3 ± 2 mmHg in the low-CVP group vs. 7 ± 3 mmHg in the GDFT group (P < 0.001). Blood loss (1425 vs. 1275 mL; P = 0.640) and the rate of major morbidity (40% vs. 50%, P = 0.751), did not differ between low-CVP and GDFT, respectively. The quality of the surgical field was comparable between groups (low-CVP 83% vs. GDFT 80%, P = 0.955). Conclusion: In major open liver resections, GDFT was not associated with differences in intraoperative blood loss, major morbidity or quality of the surgical field, compared to low-CVP. Larger RCTs are needed to confirm this finding. Registration number: NTR5821 (www.trialregister.nl).
AB - Background: Low central venous pressure (low-CVP) is the clinical standard for fluid therapy during major liver surgery. Although goal-directed fluid therapy (GDFT) has been associated with reduced morbidity and mortality in major abdominal surgery, concerns remain on blood loss when applying GDFT in liver surgery. This randomized trial compared outcomes of low-CVP and GDFT during major liver resections. Methods: In this surgeon- and patient-blinded RCT, patients undergoing major open liver resections (≥3 segments) were randomized between low-CVP (n = 20) or GDFT (n = 20). Primary outcome was intraoperative blood loss. Secondary outcomes included the quality of the surgical field (VAS scale 0 (worst)-100 (best)) and major morbidity (≥grade 3 Clavien-Dindo). Results: During surgery, CVP was 3 ± 2 mmHg in the low-CVP group vs. 7 ± 3 mmHg in the GDFT group (P < 0.001). Blood loss (1425 vs. 1275 mL; P = 0.640) and the rate of major morbidity (40% vs. 50%, P = 0.751), did not differ between low-CVP and GDFT, respectively. The quality of the surgical field was comparable between groups (low-CVP 83% vs. GDFT 80%, P = 0.955). Conclusion: In major open liver resections, GDFT was not associated with differences in intraoperative blood loss, major morbidity or quality of the surgical field, compared to low-CVP. Larger RCTs are needed to confirm this finding. Registration number: NTR5821 (www.trialregister.nl).
UR - http://www.scopus.com/inward/record.url?scp=85106336310&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.hpb.2021.03.013
DO - https://doi.org/10.1016/j.hpb.2021.03.013
M3 - Article
C2 - 34001451
SN - 1365-182X
VL - 23
SP - 1578
EP - 1585
JO - HPB
JF - HPB
IS - 10
ER -