- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03021525
Individualized Perioperative Hemodynamic Goal-directed Therapy in Major Abdominal Surgery (iPEGASUS-trial) (iPEGASUS)
Individualized Perioperative Hemodynamic Goal-directed Therapy in Major Abdominal Surgery (iPEGASUS-trial) - A Multi-center, Prospective, Randomized Trial
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Daniel A Reuter, MD
- Phone Number: +49 40 7410 52415
- Email: dreuter@uke.de
Study Contact Backup
- Name: Sebastian A Haas, MD
- Phone Number: +49 40 7410 52415
- Email: shaas@uke.de
Study Locations
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Giessen, Germany
- Justus-Liebig-University Giessen
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Hamburg, Germany, 20246
- University Medical Center Hamburg-Eppendorf
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Rostock, Germany
- University Medicine Rostock
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Ferrara, Italy
- Università degli Studi di Ferrara
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Genoa, Italy
- Università degli Studi di Genova
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Barcelona, Spain
- Hospital Santa Creu i Sant Pau
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Valencia, Spain
- Hospital Universitari i Politecnic La Fe
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- To provide high generalizability and representativeness the high number of patients with laparotomy and major surgical trauma is included into this study. - Therefore, open visceral, urological, and gynecological surgery is covered by this study.
- Expected duration of surgery must be ≥ 120 minutes and requirement of volume therapy needs to be expected ≥ 2 liters.
- Risk for any postoperative complications needs to be ≥10% assessed by the ACS (American College of Surgery)- NSQUIP (National Surgical Quality Improvement Program) risk calculator.
Exclusion Criteria:
- Patients <18 years,
- laparoscopic approach,
- patients not having sinus rhythm,
- patients having highly impaired left ventricular function (ejection fraction <30%) or severe aortic valve stenosis (aortic valve area <1 cm2, mean gradient >40 mmHg),
- pregnant women,
- emergency surgeries (surgery required within 24 hours),
- primarily vascular surgery,
- patients suffering from septic shock,
- patients having phaeochromocytoma,
- patients suffering from non-cardiac chest pain,
- refusal of consent,
- patients receiving palliative treatment only (likely to die within 6 months) and patients suffering from acute myocardial ischemia (within 30 days before randomization) are excluded from the study.
- Further, in case that clinicians intended to use cardiac output monitoring for clinical reasons patients should also not be included in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Individualized Goal Directed Therapy (iGDT)
Patients receive fluids and catecholamines following a protocol of individualized parameters achieved by extended hemodynamic monitoring.
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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.
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Active Comparator: Control
Patients in the control group will be treated according to established basic treatment goals.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite of morbidity and mortality on day 28
Time Frame: 28 days
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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.
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28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morbidity
Time Frame: Day 1,3,5,7 and 180
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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.
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Day 1,3,5,7 and 180
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Quality of life after 6 months
Time Frame: Time point of enrolment and on day180
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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.
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Time point of enrolment and on day180
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Mortality
Time Frame: Day 180
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Mortality is assessed 6 months after surgery.
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Day 180
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 301116
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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