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

Summary

To evaluate the impact of perioperative, algorithm driven, hemodynamic therapy based on individualized fluid and cardiac output optimization on postoperative moderate and severe complications in patients undergoing major abdominal surgery including visceral, urological, and gynecological operations.

In the proposed study, hemodynamic therapy is tailored individually to each patient, based on individual preload optimization by the functional parameter "pulse pressure variation (PPV)" and based on an individually titrated goal of cardiac index. The proposed study therefore further develops the concept of hemodynamic goal-directed therapy to individually set goals and is designed to assess its impact on morbidity and mortality.

Conditions

• Hemodynamic Instability
• Cardiac Output, High
• Peroperative 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.

Sponsors & Collaborators

• University of Giessen

  collaborator OTHER

• University of Rostock

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-29

Primary Completion

2023-03-27

Completion

2023-08-26

Countries

• Germany
• Italy
• Spain

Study Locations