Julia Y Nicklas1, Oliver Diener2, Maximilian Leistenschneider2, Christina Sellhorn2, Gerhard Schön3, Martin Winkler2, Guenter Daum4, Edzard Schwedhelm5, Julian Schröder6, Margit Fisch7, Barbara Schmalfeldt8, Jakob R Izbicki9, Michael Bauer10, Sina M Coldewey11, Daniel A Reuter12, Bernd Saugel13. 1. Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine. Electronic address: j.nicklas@uke.de. 2. Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine. 3. Department of Medical Biometry and Epidemiology. 4. Clinic and Polyclinic for Vascular Medicine, University Heart Center. 5. Institute of Clinical Pharmacology and Toxicology. 6. Department of Neurology. 7. Department of Urology. 8. Department of Gynecology and Gynecologic Oncology. 9. General-, Visceral and Thoracic Surgery Department and Clinic, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 10. Department of Anesthesiology and Intensive Care Medicine. 11. Department of Anesthesiology and Intensive Care Medicine; Septomics Research Center, Center for Sepsis Control and Care, Jena University Hospital, Jena, Germany. 12. Department of Anesthesiology, Rostock University Medical Center, University of Rostock, Rostock, Germany. 13. Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine; Outcomes Research Consortium, Cleveland, OH, USA.
Abstract
BACKGROUND: Despite several clinical trials on haemodynamic therapy, the optimal intraoperative haemodynamic management for high-risk patients undergoing major abdominal surgery remains unclear. We tested the hypothesis that personalised haemodynamic management targeting each individual's baseline cardiac index at rest reduces postoperative morbidity. METHODS: In this single-centre trial, 188 high-risk patients undergoing major abdominal surgery were randomised to either routine management or personalised haemodynamic management requiring clinicians to maintain personal baseline cardiac index (determined at rest preoperatively) using an algorithm that guided intraoperative i.v. fluid and/or dobutamine administration. The primary outcome was a composite of major complications (European Perioperative Clinical Outcome definitions) or death within 30 days of surgery. Secondary outcomes included postoperative morbidity (assessed by a postoperative morbidity survey), hospital length of stay, mortality within 90 days of surgery, and neurocognitive function assessed after postoperative Day 3. RESULTS: The primary outcome occurred in 29.8% (28/94) of patients in the personalised management group, compared with 55.3% (52/94) of patients in the routine management group (relative risk: 0.54, 95% confidence interval [CI]: 0.38 to 0.77; absolute risk reduction: -25.5%, 95% CI: -39.2% to -11.9%; P<0.001). One patient assigned to the personalised management group, compared with five assigned to the routine management group, died within 30 days after surgery (P=0.097). There were no clinically relevant differences between the two groups for secondary outcomes. CONCLUSIONS: In high-risk patients undergoing major abdominal surgery, personalised haemodynamic management reduces a composite outcome of major postoperative complications or death within 30 days after surgery compared with routine care. CLINICAL TRIAL REGISTRATION: NCT02834377.
RCT Entities:
BACKGROUND: Despite several clinical trials on haemodynamic therapy, the optimal intraoperative haemodynamic management for high-risk patients undergoing major abdominal surgery remains unclear. We tested the hypothesis that personalised haemodynamic management targeting each individual's baseline cardiac index at rest reduces postoperative morbidity. METHODS: In this single-centre trial, 188 high-risk patients undergoing major abdominal surgery were randomised to either routine management or personalised haemodynamic management requiring clinicians to maintain personal baseline cardiac index (determined at rest preoperatively) using an algorithm that guided intraoperative i.v. fluid and/or dobutamine administration. The primary outcome was a composite of major complications (European Perioperative Clinical Outcome definitions) or death within 30 days of surgery. Secondary outcomes included postoperative morbidity (assessed by a postoperative morbidity survey), hospital length of stay, mortality within 90 days of surgery, and neurocognitive function assessed after postoperative Day 3. RESULTS: The primary outcome occurred in 29.8% (28/94) of patients in the personalised management group, compared with 55.3% (52/94) of patients in the routine management group (relative risk: 0.54, 95% confidence interval [CI]: 0.38 to 0.77; absolute risk reduction: -25.5%, 95% CI: -39.2% to -11.9%; P<0.001). One patient assigned to the personalised management group, compared with five assigned to the routine management group, died within 30 days after surgery (P=0.097). There were no clinically relevant differences between the two groups for secondary outcomes. CONCLUSIONS: In high-risk patients undergoing major abdominal surgery, personalised haemodynamic management reduces a composite outcome of major postoperative complications or death within 30 days after surgery compared with routine care. CLINICAL TRIAL REGISTRATION: NCT02834377.
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