Individualized Perioperative Hemodynamic Goal-directed Therapy in Major Abdominal Surgery (iPEGASUS-trial)

NACompletedINTERVENTIONAL
Enrollment

380

Participants

Timeline

Start Date

August 29, 2017

Primary Completion Date

March 27, 2023

Study Completion Date

August 26, 2023

Conditions
Hemodynamic InstabilityCardiac Output, HighPeroperative Complication
Interventions
PROCEDURE

Individualized Goal Directed Therapy

The trial intervention period will commence from the induction of anesthesia until 8 hours after surgery, or until discharging from the postoperative intensive or intermediate care unit. All patients in the intervention group receive basic vital sign monitoring. For inotropic support dobutamine, and as vasopressor norepinephrine are drugs of choice. Hemodynamic management is performed according to standard treatment until an arterial line is placed. The signal of the arterial line is then processed either by calibrated or non-calibrated pulse contour analysis for pulse pressure variation (PPV) and cardiac index (CI) measurement. Fluid challenge will be performed by infusion of 500 ml in \<15 minute. Choice of fluid in case of indicated fluid loading is determined on basis of the recent guideline for intravasal volume therapy. Patients receive fluids and vasoactive agents following a protocol of individualized parameters regularly achieved by extended hemodynamic monitoring.

PROCEDURE

Control Group

Patients in the control group will be treated according to established basic treatment goals (heart rate \<100 bpm, mean arterial pressure \>65 mmHg, SpO2\>94%, and core temperature \>36° C). Basic anesthesiological monitoring by five-lead-electrocardiogram, pulse oximetry, non-invasive blood pressure monitoring and capnography is performed in every patient of the control group. Placement of an arterial and central venous line, as well as fluid and catecholamines administration, are at the discretion of the treating clinician.

Trial Locations (7)

20246

University Medical Center Hamburg-Eppendorf, Hamburg

Unknown

Justus-Liebig-University Giessen, Giessen

University Medicine Rostock, Rostock

Università degli Studi di Ferrara, Ferrara

Università degli Studi di Genova, Genoa

Hospital Santa Creu i Sant Pau, Barcelona

Hospital Universitari i Politécnic La Fe, Valencia

All Listed Sponsors
collaborator

University of Giessen

OTHER

collaborator

University of Rostock

OTHER

lead

Universitätsklinikum Hamburg-Eppendorf

OTHER

NCT03021525 - Individualized Perioperative Hemodynamic Goal-directed Therapy in Major Abdominal Surgery (iPEGASUS-trial) | Biotech Hunter | Biotech Hunter