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 in | British journal of anaesthesia : BJA Vol. 133; no. 2; pp. 277 - 287 |
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Main Authors | , , , , , , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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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. |
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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 |
Author_xml | – sequence: 1 givenname: Sandra orcidid: 0000-0003-2239-9959 surname: Funcke fullname: Funcke, Sandra organization: Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany – sequence: 2 givenname: Götz orcidid: 0000-0003-2346-4265 surname: Schmidt fullname: Schmidt, Götz organization: Department of Anesthesiology, Operative Intensive Care and Pain Therapy, Justus-Liebig-University Giessen, Giessen, Germany – sequence: 3 givenname: Alina orcidid: 0000-0001-8240-3812 surname: Bergholz fullname: Bergholz, Alina organization: Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany – sequence: 4 givenname: Pilar surname: Argente Navarro fullname: Argente Navarro, Pilar organization: Department of Anesthesiology, Perioperative Medicine Research Group, Hospital Universitari i Politécnic La Fe, Valencia, Spain – sequence: 5 givenname: Gonzalo orcidid: 0000-0002-1084-8799 surname: Azparren Cabezón fullname: Azparren Cabezón, Gonzalo organization: Department of Anesthesia and Pain Management, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain – sequence: 6 givenname: Silvia orcidid: 0000-0003-4892-749X surname: Barbero-Espinosa fullname: Barbero-Espinosa, Silvia organization: Department of Anesthesia and Pain Management, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain – sequence: 7 givenname: Oscar surname: Diaz-Cambronero fullname: Diaz-Cambronero, Oscar organization: Department of Anesthesiology, Perioperative Medicine Research Group, Hospital Universitari i Politécnic La Fe, Valencia, Spain – sequence: 8 givenname: Fabian surname: Edinger fullname: Edinger, Fabian organization: Department of Anesthesiology, Operative Intensive Care and Pain Therapy, Justus-Liebig-University Giessen, Giessen, Germany – sequence: 9 givenname: Nuria surname: García-Gregorio fullname: García-Gregorio, Nuria organization: Department of Anesthesiology, Perioperative Medicine Research Group, Hospital Universitari i Politécnic La Fe, Valencia, Spain – sequence: 10 givenname: Marit surname: Habicher fullname: Habicher, Marit organization: Department of Anesthesiology, Operative Intensive Care and Pain Therapy, Justus-Liebig-University Giessen, Giessen, Germany – sequence: 11 givenname: Gerd orcidid: 0000-0002-8922-8700 surname: Klinkmann fullname: Klinkmann, Gerd organization: Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Medical Centre of Rostock, Rostock, Germany – sequence: 12 givenname: Christian orcidid: 0000-0002-2655-7363 surname: Koch fullname: Koch, Christian organization: Department of Anesthesiology, Operative Intensive Care and Pain Therapy, Justus-Liebig-University Giessen, Giessen, Germany – sequence: 13 givenname: Alina orcidid: 0000-0002-0929-2172 surname: Kröker fullname: Kröker, Alina organization: Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany – sequence: 14 givenname: Thomas surname: Mencke fullname: Mencke, Thomas organization: Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Medical Centre of Rostock, Rostock, Germany – sequence: 15 givenname: Victoria surname: Moral García fullname: Moral García, Victoria organization: Department of Anesthesia and Pain Management, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain – sequence: 16 givenname: Amelie orcidid: 0000-0003-4318-4017 surname: Zitzmann fullname: Zitzmann, Amelie organization: Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Medical Centre of Rostock, Rostock, Germany – sequence: 17 givenname: Susanne surname: Lezius fullname: Lezius, Susanne organization: Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany – sequence: 18 givenname: Amra orcidid: 0000-0002-9266-4554 surname: Pepić fullname: Pepić, Amra organization: Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany – sequence: 19 givenname: Daniel I. orcidid: 0000-0001-9932-3077 surname: Sessler fullname: Sessler, Daniel I. organization: Outcomes Research Consortium, Department of Anesthesiology, Cleveland Clinic, Cleveland, OH, USA – sequence: 20 givenname: Michael orcidid: 0000-0003-1677-3609 surname: Sander fullname: Sander, Michael organization: Department of Anesthesiology, Operative Intensive Care and Pain Therapy, Justus-Liebig-University Giessen, Giessen, Germany – sequence: 21 givenname: Sebastian A. surname: Haas fullname: Haas, Sebastian A. organization: Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Medical Centre of Rostock, Rostock, Germany – sequence: 22 givenname: Daniel A. orcidid: 0000-0003-2080-5597 surname: Reuter fullname: Reuter, Daniel A. organization: Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Medical Centre of Rostock, Rostock, Germany – sequence: 23 givenname: Bernd orcidid: 0000-0001-6619-0722 surname: Saugel fullname: Saugel, Bernd email: bernd.saugel@gmx.de organization: Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany |
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Keywords | cardiac output haemodynamic monitoring cardiovascular dynamics individualised mortality randomised controlled trial morbidity anaesthesia |
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Snippet | It is unclear whether optimising intraoperative cardiac index can reduce postoperative complications. We tested the hypothesis that maintaining optimised... |
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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 |
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