Hemodynamic Instability Clinical Trial
— iPEGASUSOfficial title:
Individualized Perioperative Hemodynamic Goal-directed Therapy in Major Abdominal Surgery (iPEGASUS-trial) - A Multi-center, Prospective, Randomized Trial
NCT number | NCT03021525 |
Other study ID # | 301116 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 29, 2017 |
Est. completion date | August 26, 2023 |
Verified date | January 2024 |
Source | Universitätsklinikum Hamburg-Eppendorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 380 |
Est. completion date | August 26, 2023 |
Est. primary completion date | March 27, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Germany | Justus-Liebig-University Giessen | Giessen | |
Germany | University Medical Center Hamburg-Eppendorf | Hamburg | |
Germany | University Medicine Rostock | Rostock | |
Italy | Università degli Studi di Ferrara | Ferrara | |
Italy | Università degli Studi di Genova | Genoa | |
Spain | Hospital Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital Universitari i Politécnic La Fe | Valencia |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf | University of Giessen, University of Rostock |
Germany, Italy, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite of morbidity and mortality on day 28 | 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. | 28 days | |
Secondary | Morbidity | 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. | Day 1,3,5,7 and 180 | |
Secondary | Quality of life after 6 months | 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. | Time point of enrolment and on day180 | |
Secondary | Mortality | Mortality is assessed 6 months after surgery. | Day 180 |
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