Cardiac index-guided therapy to maintain optimised postinduction cardiac index in high-risk patients having major open abdominal surgery: the multicentre randomised iPEGASUS trial

It is unclear whether optimising intraoperative cardiac index can reduce postoperative complications. We tested the hypothesis that maintaining optimised postinduction cardiac index during and for the first 8 h after surgery reduces the incidence of a composite outcome of complications within 28 day...

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Published inBritish journal of anaesthesia : BJA Vol. 133; no. 2; pp. 277 - 287
Main Authors Funcke, Sandra, Schmidt, Götz, Bergholz, Alina, Argente Navarro, Pilar, Azparren Cabezón, Gonzalo, Barbero-Espinosa, Silvia, Diaz-Cambronero, Oscar, Edinger, Fabian, García-Gregorio, Nuria, Habicher, Marit, Klinkmann, Gerd, Koch, Christian, Kröker, Alina, Mencke, Thomas, Moral García, Victoria, Zitzmann, Amelie, Lezius, Susanne, Pepić, Amra, Sessler, Daniel I., Sander, Michael, Haas, Sebastian A., Reuter, Daniel A., Saugel, Bernd
Format Journal Article
LanguageEnglish
Published England Elsevier Ltd 01.08.2024
Elsevier
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Abstract It is unclear whether optimising intraoperative cardiac index can reduce postoperative complications. We tested the hypothesis that maintaining optimised postinduction cardiac index during and for the first 8 h after surgery reduces the incidence of a composite outcome of complications within 28 days after surgery compared with routine care in high-risk patients having elective major open abdominal surgery. In three German and two Spanish centres, high-risk patients having elective major open abdominal surgery were randomised to cardiac index-guided therapy to maintain optimised postinduction cardiac index (cardiac index at which pulse pressure variation was <12%) during and for the first 8 h after surgery using intravenous fluids and dobutamine or to routine care. The primary outcome was the incidence of a composite outcome of moderate or severe complications within 28 days after surgery. We analysed 318 of 380 enrolled subjects. The composite primary outcome occurred in 84 of 152 subjects (55%) assigned to cardiac index-guided therapy and in 77 of 166 subjects (46%) assigned to routine care (odds ratio: 1.87, 95% confidence interval: 1.03–3.39, P=0.038). Per-protocol analyses confirmed the results of the primary outcome analysis. Maintaining optimised postinduction cardiac index during and for the first 8 h after surgery did not reduce, and possibly increased, the incidence of a composite outcome of complications within 28 days after surgery compared with routine care in high-risk patients having elective major open abdominal surgery. Clinicians should not strive to maintain optimised postinduction cardiac index during and after surgery in expectation of reducing complications. NCT03021525.
AbstractList It is unclear whether optimising intraoperative cardiac index can reduce postoperative complications. We tested the hypothesis that maintaining optimised postinduction cardiac index during and for the first 8 h after surgery reduces the incidence of a composite outcome of complications within 28 days after surgery compared with routine care in high-risk patients having elective major open abdominal surgery. In three German and two Spanish centres, high-risk patients having elective major open abdominal surgery were randomised to cardiac index-guided therapy to maintain optimised postinduction cardiac index (cardiac index at which pulse pressure variation was <12%) during and for the first 8 h after surgery using intravenous fluids and dobutamine or to routine care. The primary outcome was the incidence of a composite outcome of moderate or severe complications within 28 days after surgery. We analysed 318 of 380 enrolled subjects. The composite primary outcome occurred in 84 of 152 subjects (55%) assigned to cardiac index-guided therapy and in 77 of 166 subjects (46%) assigned to routine care (odds ratio: 1.87, 95% confidence interval: 1.03-3.39, P=0.038). Per-protocol analyses confirmed the results of the primary outcome analysis. Maintaining optimised postinduction cardiac index during and for the first 8 h after surgery did not reduce, and possibly increased, the incidence of a composite outcome of complications within 28 days after surgery compared with routine care in high-risk patients having elective major open abdominal surgery. Clinicians should not strive to maintain optimised postinduction cardiac index during and after surgery in expectation of reducing complications. NCT03021525.
It is unclear whether optimising intraoperative cardiac index can reduce postoperative complications. We tested the hypothesis that maintaining optimised postinduction cardiac index during and for the first 8 h after surgery reduces the incidence of a composite outcome of complications within 28 days after surgery compared with routine care in high-risk patients having elective major open abdominal surgery.BACKGROUNDIt is unclear whether optimising intraoperative cardiac index can reduce postoperative complications. We tested the hypothesis that maintaining optimised postinduction cardiac index during and for the first 8 h after surgery reduces the incidence of a composite outcome of complications within 28 days after surgery compared with routine care in high-risk patients having elective major open abdominal surgery.In three German and two Spanish centres, high-risk patients having elective major open abdominal surgery were randomised to cardiac index-guided therapy to maintain optimised postinduction cardiac index (cardiac index at which pulse pressure variation was <12%) during and for the first 8 h after surgery using intravenous fluids and dobutamine or to routine care. The primary outcome was the incidence of a composite outcome of moderate or severe complications within 28 days after surgery.METHODSIn three German and two Spanish centres, high-risk patients having elective major open abdominal surgery were randomised to cardiac index-guided therapy to maintain optimised postinduction cardiac index (cardiac index at which pulse pressure variation was <12%) during and for the first 8 h after surgery using intravenous fluids and dobutamine or to routine care. The primary outcome was the incidence of a composite outcome of moderate or severe complications within 28 days after surgery.We analysed 318 of 380 enrolled subjects. The composite primary outcome occurred in 84 of 152 subjects (55%) assigned to cardiac index-guided therapy and in 77 of 166 subjects (46%) assigned to routine care (odds ratio: 1.87, 95% confidence interval: 1.03-3.39, P=0.038). Per-protocol analyses confirmed the results of the primary outcome analysis.RESULTSWe analysed 318 of 380 enrolled subjects. The composite primary outcome occurred in 84 of 152 subjects (55%) assigned to cardiac index-guided therapy and in 77 of 166 subjects (46%) assigned to routine care (odds ratio: 1.87, 95% confidence interval: 1.03-3.39, P=0.038). Per-protocol analyses confirmed the results of the primary outcome analysis.Maintaining optimised postinduction cardiac index during and for the first 8 h after surgery did not reduce, and possibly increased, the incidence of a composite outcome of complications within 28 days after surgery compared with routine care in high-risk patients having elective major open abdominal surgery. Clinicians should not strive to maintain optimised postinduction cardiac index during and after surgery in expectation of reducing complications.CONCLUSIONSMaintaining optimised postinduction cardiac index during and for the first 8 h after surgery did not reduce, and possibly increased, the incidence of a composite outcome of complications within 28 days after surgery compared with routine care in high-risk patients having elective major open abdominal surgery. Clinicians should not strive to maintain optimised postinduction cardiac index during and after surgery in expectation of reducing complications.NCT03021525.CLINICAL TRIAL REGISTRATIONNCT03021525.
Author Mencke, Thomas
Haas, Sebastian A.
Funcke, Sandra
Zitzmann, Amelie
Klinkmann, Gerd
Sander, Michael
Diaz-Cambronero, Oscar
Moral García, Victoria
Azparren Cabezón, Gonzalo
Habicher, Marit
Argente Navarro, Pilar
Barbero-Espinosa, Silvia
Edinger, Fabian
García-Gregorio, Nuria
Saugel, Bernd
Pepić, Amra
Sessler, Daniel I.
Bergholz, Alina
Lezius, Susanne
Kröker, Alina
Reuter, Daniel A.
Koch, Christian
Schmidt, Götz
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Issue 2
Keywords cardiac output
haemodynamic monitoring
cardiovascular dynamics
individualised
mortality
randomised controlled trial
morbidity
anaesthesia
Language English
License This is an open access article under the CC BY license.
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Snippet It is unclear whether optimising intraoperative cardiac index can reduce postoperative complications. We tested the hypothesis that maintaining optimised...
SourceID pubmedcentral
proquest
pubmed
crossref
elsevier
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StartPage 277
SubjectTerms Abdomen - surgery
Aged
Aged, 80 and over
anaesthesia
Cardiac Output
Cardiotonic Agents - administration & dosage
Cardiotonic Agents - therapeutic use
Cardiovascular
cardiovascular dynamics
Dobutamine - administration & dosage
Elective Surgical Procedures - adverse effects
Female
Fluid Therapy - methods
haemodynamic monitoring
Humans
individualised
Male
Middle Aged
Monitoring, Intraoperative - methods
morbidity
mortality
Postoperative Complications - epidemiology
Postoperative Complications - prevention & control
randomised controlled trial
Title Cardiac index-guided therapy to maintain optimised postinduction cardiac index in high-risk patients having major open abdominal surgery: the multicentre randomised iPEGASUS trial
URI https://dx.doi.org/10.1016/j.bja.2024.03.040
https://www.ncbi.nlm.nih.gov/pubmed/38797635
https://www.proquest.com/docview/3060751741
https://pubmed.ncbi.nlm.nih.gov/PMC11282469
Volume 133
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