Hemodynamic InstabilityiPEGASUSNCT03021525
Individualized Perioperative Hemodynamic Goal-directed Therapy in Major Abdominal Surgery (iPEGASUS-trial)
A study testing Individualized Goal Directed Therapy in people with Hemodynamic Instability and Cardiac Output, High, run by Universitätsklinikum Hamburg-Eppendorf at 7 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Instability, Cardiac Output, High, Peroperative Complication
- What is being tested?
- Individualized Goal Directed Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 29 Aug 2017to 26 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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),
Show all 13Show fewer
- 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.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Germany3 sites
Justus-Liebig-University Giessen
Giessen
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
University Medicine Rostock
Rostock
Italy2 sites
Università degli Studi di Ferrara
Ferrara
Università degli Studi di Genova
Genoa
Spain2 sites
Hospital Santa Creu i Sant Pau
Barcelona
Hospital Universitari i Politécnic La Fe
Valencia
About this study
Official title: 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.
Read the detailed description
Postoperative mortality in patients undergoing surgery is on average still 4% in Europe as evaluated recently in a cohort study across 28 European countries and is considered to be even higher in high risk surgery. But besides this significant risk of death, in particular moderate and severe postoperative complications, affecting up to 40% of patients after major surgery, frequently lead to severe reductions of quality of life and cause high healthcare costs in western nations. Perioperative hemodynamic goal-directed optimization is believed to be an integral part to reduce in particular postoperative morbidity significantly and possibly also mortality. Algorithm driven optimization of macrocirculation aiming on best possible oxygen and substrate delivery to end organs and tissues is thought to be the theoretical mechanism of this therapy. A recent large multi-center trial based on such a pragmatic, non-individualized protocol failed to reduce composite morbidity underlining this weak point of this approach. The reason for failing statistically significant improvement of clinical outcome first of all has to be seen in not taking into account individual hemodynamic needs of each single patient. Every patient was hemodynamically treated according to a "one size fits all of maximizing stroke volume" approach. In contrast, a first mono-center trial gave evidence that individualized early goal-directed therapy based on an individually optimized volumetric cardiac preload parameter (global end-diastolic volume) reduces complications and ICU length of stay after cardiac surgery. Further, and even more important, a first multi-center pilot study using a goal-directed algorithm aiming to optimize blood flow oriented on individual cardiac capacities (individualized optimal cardiac index) in major abdominal surgery demonstrated feasibility and a reduction in postoperative complications. This finding needs to be confirmed in a multi-center study that is adequately powered to detect changes in specific complications and in mortality before clinical practice can be changed accordingly. Therefore, the hypothesis of this proposed prospective two arm randomized study is that algorithm driven individualized hemodynamic goal-directed therapy reduces moderate and severe postoperative complications being a massive burden on quality of life and health care costs. The proposed study develops the concept of hemodynamic goal-directed therapy to individually set goals and is designed to assess its impact on morbidity and mortality.
- Being tested
- Individualized Goal Directed Therapy, Control Group
- Keywords
- Goal-directed therapy, postoperative morbidity, haemodynamic optimisation, individualised medicine, Pulse pressure variation, Cardiac output
- Medical subject headings
- Cardiac Output, High, Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Goal Directed TherapyProcedure or surgery
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.
Control GroupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Goal Directed Therapy (iGDT) | Experimental | Patients receive fluids and catecholamines following a protocol of individualized parameters achieved by extended hemodynamic monitoring. Receives: Procedure: Individualized Goal Directed Therapy |
| Control | Active comparator | Patients in the control group will be treated according to established basic treatment goals. Receives: Procedure: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (3)
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.
Measured: Day 1,3,5,7 and 180
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.
Measured: Time point of enrolment and on day180
Mortality
Mortality is assessed 6 months after surgery.
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start29 Aug 2017
- Primary completion27 Mar 2023
- Study completion26 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- University of Giessen, University of Rostock
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021525
- Sponsor's protocol ID
- 301116
- Acronym
- iPEGASUS
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2017
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To enter a patient into the iPEGASUS trial, research staff at site will log on to a secure web-based randomization system via a link to the respective website and complete the patient's details without individual participant data (name, date of birth etc.) to obtain a unique patient number and allocation to a treatment group. The local main investigator (LMI) will then be informed about patient's enrollment. For correct patient's data follow up only the LMI will set up a list with the possibility to retrace the patient's history. Personalized data will be handled by the LMI according to GCP (good clinical practice) requirements and will be stored separately from the obtained study data. Thereby, data in the eCRF (electronic case report form) itself will not be re-traceable anymore and visible only for the Principal Coordinators (PCs) for data analysis. Data management of the eCRF will be performed by a company specialized in full service study data management.
Publications
Funcke S, Schmidt G, Bergholz A, Argente Navarro P, Azparren Cabezon G, Barbero-Espinosa S, Diaz-Cambronero O, Edinger F, Garcia-Gregorio N, Habicher M, Klinkmann G, Koch C, Kroker A, Mencke T, Moral Garcia V, Zitzmann A, Lezius S, Pepic A, Sessler DI, Sander M, Haas SA, Reuter DA, Saugel B. Cardiac index-guided therapy to maintain optimised postinduction cardiac index in high-risk patients having major open abdominal surgery: the multicentre randomised iPEGASUS trial. Br J Anaesth. 2024 Aug;133(2):277-287. doi: 10.1016/j.bja.2024.03.040. Epub 2024 May 26.
PubMed 38797635Funcke S, Saugel B, Koch C, Schulte D, Zajonz T, Sander M, Gratarola A, Ball L, Pelosi P, Spadaro S, Ragazzi R, Volta CA, Mencke T, Zitzmann A, Neukirch B, Azparren G, Gine M, Moral V, Pinnschmidt HO, Diaz-Cambronero O, Estelles MJA, Velez ME, Montanes MV, Belda J, Soro M, Puig J, Reuter DA, Haas SA. Individualized, perioperative, hemodynamic goal-directed therapy in major abdominal surgery (iPEGASUS trial): study protocol for a randomized controlled trial. Trials. 2018 May 9;19(1):273. doi: 10.1186/s13063-018-2620-9.
PubMed 29743101
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Perioperative Hemodynamic Goal-directed Therapy in Major Abdominal Surgery (iPEGASUS-trial) - A Multi-center, Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT03021525
- Acronym / sponsor ID
- iPEGASUS / 301116
- Keywords
- Goal-directed therapy, postoperative morbidity, haemodynamic optimisation, individualised medicine, Pulse pressure variation, Cardiac output
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- University of Giessen, University of Rostock
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 26 Aug 2023 (actual)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Postoperative mortality in patients undergoing surgery is on average still 4% in Europe as evaluated recently in a cohort study across 28 European countries and is considered to be even higher in high risk surgery. But besides this significant risk of death, in particular moderate and severe postoperative complications, affecting up to 40% of patients after major surgery, frequently lead to severe reductions of quality of life and cause high healthcare costs in western nations. Perioperative hemodynamic goal-directed optimization is believed to be an integral part to reduce in particular postoperative morbidity significantly and possibly also mortality. Algorithm driven optimization of macrocirculation aiming on best possible oxygen and substrate delivery to end organs and tissues is thought to be the theoretical mechanism of this therapy. A recent large multi-center trial based on such a pragmatic, non-individualized protocol failed to reduce composite morbidity underlining this weak point of this approach. The reason for failing statistically significant improvement of clinical outcome first of all has to be seen in not taking into account individual hemodynamic needs of each single patient. Every patient was hemodynamically treated according to a "one size fits all of maximizing stroke volume" approach. In contrast, a first mono-center trial gave evidence that individualized early goal-directed therapy based on an individually optimized volumetric cardiac preload parameter (global end-diastolic volume) reduces complications and ICU length of stay after cardiac surgery. Further, and even more important, a first multi-center pilot study using a goal-directed algorithm aiming to optimize blood flow oriented on individual cardiac capacities (individualized optimal cardiac index) in major abdominal surgery demonstrated feasibility and a reduction in postoperative complications. This finding needs to be confirmed in a multi-center study that is adequately powered to detect changes in specific complications and in mortality before clinical practice can be changed accordingly. Therefore, the hypothesis of this proposed prospective two arm randomized study is that algorithm driven individualized hemodynamic goal-directed therapy reduces moderate and severe postoperative complications being a massive burden on quality of life and health care costs. The proposed study develops the concept of hemodynamic goal-directed therapy to individually set goals and is designed to assess its impact on morbidity and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized Goal Directed Therapy (iGDT) | Experimental | Procedure: Individualized Goal Directed TherapyPatients receive fluids and catecholamines following a protocol of individualized parameters achieved by extended hemodynamic monitoring. |
| Control | Active comparator | Procedure: Control GroupPatients in the control group will be treated according to established basic treatment goals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Goal Directed TherapyThe 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 or surgery | Individualized Goal Directed Therapy (iGDT) |
| Control GroupPatients 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. | Procedure or surgery | Control |
Primary outcome
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.
3 secondary outcomes
Morbidity
Time frame: Day 1,3,5,7 and 180
Quality of life after 6 months
Time frame: Time point of enrolment and on day180
Mortality
Time frame: Day 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Derived from this study: PubMed 38797635Funcke S, Schmidt G, Bergholz A, Argente Navarro P, Azparren Cabezon G, Barbero-Espinosa S, Diaz-Cambronero O, Edinger F, Garcia-Gregorio N, Habicher M, Klinkmann G, Koch C, Kroker A, Mencke T, Moral Garcia V, Zitzmann A, Lezius S, Pepic A, Sessler DI, Sander M, Haas SA, Reuter DA, Saugel B. Cardiac index-guided therapy to maintain optimised postinduction cardiac index in high-risk patients having major open abdominal surgery: the multicentre randomised iPEGASUS trial. Br J Anaesth. 2024 Aug;133(2):277-287. doi: 10.1016/j.bja.2024.03.040. Epub 2024 May 26.
- Derived from this study: PubMed 29743101Funcke S, Saugel B, Koch C, Schulte D, Zajonz T, Sander M, Gratarola A, Ball L, Pelosi P, Spadaro S, Ragazzi R, Volta CA, Mencke T, Zitzmann A, Neukirch B, Azparren G, Gine M, Moral V, Pinnschmidt HO, Diaz-Cambronero O, Estelles MJA, Velez ME, Montanes MV, Belda J, Soro M, Puig J, Reuter DA, Haas SA. Individualized, perioperative, hemodynamic goal-directed therapy in major abdominal surgery (iPEGASUS trial): study protocol for a randomized controlled trial. Trials. 2018 May 9;19(1):273. doi: 10.1186/s13063-018-2620-9.
- Individual participant dataSharing planned: No. To enter a patient into the iPEGASUS trial, research staff at site will log on to a secure web-based randomization system via a link to the respective website and complete the patient's details without individual participant data (name, date of birth etc.) to obtain a unique patient number and allocation to a treatment group. The local main investigator (LMI) will then be informed about patient's enrollment. For correct patient's data follow up only the LMI will set up a list with the possibility to retrace the patient's history. Personalized data will be handled by the LMI according to GCP (good clinical practice) requirements and will be stored separately from the obtained study data. Thereby, data in the eCRF (electronic case report form) itself will not be re-traceable anymore and visible only for the Principal Coordinators (PCs) for data analysis. Data management of the eCRF will be performed by a company specialized in full service study data management.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Goal Directed Therapy in people with Hemodynamic Instability and Cardiac Output, High, run by Universitätsklinikum Hamburg-Eppendorf at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of morbidity and mortality on day 28 (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03021525, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.