Individualized Perioperative Hemodynamic Goal-directed Therapy in Major Abdominal Surgery (iPEGASUS-trial) (iPEGASUS)
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|ClinicalTrials.gov Identifier: NCT03021525|
Recruitment Status : Recruiting
First Posted : January 16, 2017
Last Update Posted : November 17, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Hemodynamic Instability Cardiac Output, High Peroperative Complication||Procedure: Individualized Goal Directed Therapy Procedure: Control Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||380 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Individualized Perioperative Hemodynamic Goal-directed Therapy in Major Abdominal Surgery (iPEGASUS-trial) - A Multi-center, Prospective, Randomized Trial|
|Actual Study Start Date :||August 23, 2017|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
Experimental: Individualized Goal Directed Therapy (iGDT)
Patients receive fluids and catecholamines following a protocol of individualized parameters achieved by extended hemodynamic monitoring.
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.
Active Comparator: Control
Patients in the control group will be treated according to established basic treatment goals.
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.
- Composite of morbidity and mortality on day 28 [ Time Frame: 28 days ]Considering the high relevance for the individual patient and the society, postoperative outcome is most appropriately reflected by a combination of morbidity and mortality. Therefore, the primary endpoint is a composite comprising rate of patients with one or more moderate or severe postoperative complications or death within 28 days post surgery. Moderate and severe postoperative complications are defined on the basis of a consensus statement of an ESA (European Society of Anesthesiology)- ESICM (European Society of Intensive Care Medicine) joint task force on perioperative outcome measures.
- Morbidity [ Time Frame: Day 1,3,5,7 and 180 ]At these days both, number of complications and number of patients having at least one moderate or severe complication, will be assessed in total and for every complication. The additional secondary endpoints including days alive and free of mechanical ventilation at 7 days and 28 days, days alive and free of vasopressor therapy at 7 days and 28 days, days alive and free of renal replacement therapy at 7 days and 28 days, length of ICU and hospital stay further characterize perioperative morbidity and its socioeconomic impacts.
- Quality of life after 6 months [ Time Frame: Time point of enrolment and on day180 ]For assessment of quality of life an interview (personal or by telephone) based on the EQ-5D-5L (EuroQol Research Foundation) questionnaire is performed at the time point of enrolment and 6 months after surgery.
- Mortality [ Time Frame: Day 180 ]Mortality is assessed 6 months after surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03021525
|Contact: Daniel A Reuter, MD||+49 40 7410 firstname.lastname@example.org|
|Contact: Sebastian A Haas, MD||+49 40 7410 email@example.com|
|University Medical Center Hamburg-Eppendorf||Not yet recruiting|
|Hamburg, Germany, 20246|
|Contact: Christian Zoellner, Prof. +49 40 7410 52415 firstname.lastname@example.org|
|Contact: Daniel A Reuter, Prof. +49 40 7410 52415 email@example.com|
|Principal Investigator: Sandra Funcke, MD|
|Principal Investigator: Bernd Saugel, MD|
|Principal Investigator: Daniel A Reuter, MD|
|Principal Investigator: Sebastian A Haas, MD|
|University Medicine Rostock||Recruiting|
|Università degli Studi di Ferrara||Not yet recruiting|
|Università degli Studi di Genova||Not yet recruiting|
|Hospital Santa Creu i Sant Pau||Not yet recruiting|
|Hospital Universitari i Politécnic La Fe||Not yet recruiting|