Major Abdominal SurgeryPhase 4CORVasoNCT04935814
Cardiac Output Response to Vasopressin Infusion In Abdominal Surgery Patients Under Mechanical Ventilation
A Phase 4 study testing Vasopressin, Arginine in people with Major Abdominal Surgery and General Anesthesia, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
In this study, the investigators propose to explore the hemodynamic variations induced by vasopressin and its influence on cardiac output, mean systemic pressure, and venous return resistance measured through cardiopulmonary interactions, according to the approach proposed by Guyton, in patients undergoing major… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Abdominal Surgery, General Anesthesia, Mechanical Ventilation
- What is being tested?
- Vasopressin, Arginine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2021to 2 Aug 2022
- Phase
- Phase 4
- 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
- Adults above 18
- Planned for a major abdominal surgery under general anesthesia
- Under mechanical ventilation
- Presence of a central venous and arterial lines allowing transpulmonary thermodilution cardiac output measurement
- Patient's consent with a social insurance
Who cannot join
- Do not consent to participate
- History of heart attack, arteriopathy or aneurysm
- Contraindication to use transpulmonary thermodilution to measure cardiac output :
- coagulopathy
- cardiac arrythmia
- presence of pace-maker or defibrillator
Show all 17Show fewer
- severe valvulopathy
- Patients with Acute Respiratory Distress Syndrome (according to Berlin criteria)
- History of arterial hypertension (treated or not)
- History of seizure, chronic headache, asthma or heart failure
- Left Ventricular Ejection Fraction (LVEF) < 45% or right ventricular dysfunction
- History of pulmonary lobectomy or surgery
- History of restrictive or obstructive pulmonary disease
- Body Mass Index (BMI) < 15 or > 40 kg/m²
- Pregnancy
- Known allergy to vasopressin
- Patients under protection of justice (guardianship, curators...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac Output Response to Vasopressin Infusion In Abdominal Surgery Patients Under Mechanical Ventilation: A Clinical Pharmacodynamics Study
In this study, the investigators propose to explore the hemodynamic variations induced by vasopressin and its influence on cardiac output, mean systemic pressure, and venous return resistance measured through cardiopulmonary interactions, according to the approach proposed by Guyton, in patients undergoing major abdominal surgeries.
Read the detailed description
Maintaining hemodynamic stability is one of the main objectives of the anesthesiologist or the intensivist, either in the ICU or the OR. This consists of optimizing cardiac output to ensure satisfactory systemic perfusion during the peri-operative period or the ICU stay. The occurrence of oxygen debt (mismatch between oxygen consumption and transport) and/or tissue hypoperfusion are key factors in the development of organ failure. Numerous studies have shown in recent years that individualized hemodynamic optimization (cardiac output and organ perfusion pressure) reduces the risk of postoperative and ICU morbidity and mortality.
Monitoring of cardiac output and stroke volume is a valuable and essential aid in determining the therapies to be used for this optimization, whether it involves volume expansion or the use of a vasopressor or even inotropic agent.
Several vasopressor therapies have been available to date. Norepinephrine is currently the reference in the treatment of vasoplegic shock states, but also in the operating room during major surgery or in fragile patients. Other molecules are currently available and are used in a disparate manner, according to the habits of each practitioner, sometimes outside regulatory rules, not following international recommendations concerning the pathology in question: adrenaline, dopamine, phenylephrine, terlipressin...
Vasopressin (D-arginine-D-vasopressin) is an endogenous hormone synthesized by the hypothalamus (peptide composed of 9 amino acids) which has an antidiuretic renal action through its V2 receptor but also a vasoconstriction activity through its V1a receptor, at the level of the smooth muscles of the vascular wall. It also participates in the stimulation of catecholamine secretion by the adrenal medulla. Vasopressin is commercially available under the name "argipressin". It is currently indicated as an adjunct to other vasopressors such as norepinephrine in refractory septic shock to maintain satisfactory hemodynamic stability.
However, its vasoconstrictive and hemodynamic effects, including its influence on cardiac output, have never been studied to date and to the knowledge of investigators. In particular, there are no studies showing the influence of this molecule on mean systemic pressure and venous return resistance, which are fundamental determinants of its impact on left heart function and thus on cardiac output.
In this study, the investigators propose to explore the hemodynamic variations induced by vasopressin and its influence on cardiac output, mean systemic pressure, and venous return resistance measured through cardiopulmonary interactions, according to the approach proposed by Guyton.
- Being tested
- Vasopressin, Arginine
- Keywords
- Vasopressin, Argipressin, Cardiac Output, General Anesthesia, Mechanical Ventilation
- Medical subject headings
- Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vasopressin, ArginineDrug
Once vasopressin infusion started, patients positions will be randomized: Trendelenburg (-30°), anti Trendelenburg (+30°) and supine position (0°).
| Study group | Role | What they receive |
|---|---|---|
| Continuous vasopressin infusion | Experimental | After general anesthesia, patients will receive a continuous infusion of vasopressin in order to improve mean arterial pressure by 20 mmHg. Receives: Drug: Vasopressin, Arginine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of cardiac output after an infusion of vasopressin at different levels of cardiac preload
Using a thermodilution method, cardiac output will be measured and recorded at different levels of cardiac preload obtained by changing patient's position (Trendelenburg, anti-Trendelenburg and supine position).
Measured: 15 minutes after position change
Secondary outcomes (2)
Variation of mean systemic filling pressure and venous return after an infusion of vasopressin at different levels of cardiac preload
Mean systemic filling pressure will be determined by plotting the venous return curve using the cardiopulmonary interaction described by Guyton, by changing patient's position (Trendelenburg, anti-Trendelenburg and supine position).
Measured: 15 minutes after position change
Variation of central venous pressure after an infusion of vasopressin at different levels of cardiac preload
Using a central venous catheter, the central venous pressure will be determined.
Measured: 15 minutes after position change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start9 Jun 2021
- Primary completion2 Aug 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- CORVaso is a pharmacological trial which aims to determine the variations of cardiac output during vasopressin infusion in major abdominal surgery patients.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Godet, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935814
- Sponsor's protocol ID
- CORVaso / RBHP 2021 GODET 2
- Acronym
- CORVaso
- Status last verified
- Dec 2022
- First submitted
- 15 Jun 2021
- Last updated
- 5 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Output Response to Vasopressin Infusion In Abdominal Surgery Patients Under Mechanical Ventilation: A Clinical Pharmacodynamics Study
- ClinicalTrials.gov ID
- NCT04935814
- Acronym / sponsor ID
- CORVaso / CORVaso / RBHP 2021 GODET 2
- Keywords
- Vasopressin, Argipressin, Cardiac Output, General Anesthesia, Mechanical Ventilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 23 Jun 2021 (actual)
- 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.
In this study, the investigators propose to explore the hemodynamic variations induced by vasopressin and its influence on cardiac output, mean systemic pressure, and venous return resistance measured through cardiopulmonary interactions, according to the approach proposed by Guyton, in patients undergoing major abdominal surgeries.
Detailed description
Maintaining hemodynamic stability is one of the main objectives of the anesthesiologist or the intensivist, either in the ICU or the OR. This consists of optimizing cardiac output to ensure satisfactory systemic perfusion during the peri-operative period or the ICU stay. The occurrence of oxygen debt (mismatch between oxygen consumption and transport) and/or tissue hypoperfusion are key factors in the development of organ failure. Numerous studies have shown in recent years that individualized hemodynamic optimization (cardiac output and organ perfusion pressure) reduces the risk of postoperative and ICU morbidity and mortality.
Monitoring of cardiac output and stroke volume is a valuable and essential aid in determining the therapies to be used for this optimization, whether it involves volume expansion or the use of a vasopressor or even inotropic agent.
Several vasopressor therapies have been available to date. Norepinephrine is currently the reference in the treatment of vasoplegic shock states, but also in the operating room during major surgery or in fragile patients. Other molecules are currently available and are used in a disparate manner, according to the habits of each practitioner, sometimes outside regulatory rules, not following international recommendations concerning the pathology in question: adrenaline, dopamine, phenylephrine, terlipressin...
Vasopressin (D-arginine-D-vasopressin) is an endogenous hormone synthesized by the hypothalamus (peptide composed of 9 amino acids) which has an antidiuretic renal action through its V2 receptor but also a vasoconstriction activity through its V1a receptor, at the level of the smooth muscles of the vascular wall. It also participates in the stimulation of catecholamine secretion by the adrenal medulla. Vasopressin is commercially available under the name "argipressin". It is currently indicated as an adjunct to other vasopressors such as norepinephrine in refractory septic shock to maintain satisfactory hemodynamic stability.
However, its vasoconstrictive and hemodynamic effects, including its influence on cardiac output, have never been studied to date and to the knowledge of investigators. In particular, there are no studies showing the influence of this molecule on mean systemic pressure and venous return resistance, which are fundamental determinants of its impact on left heart function and thus on cardiac output.
In this study, the investigators propose to explore the hemodynamic variations induced by vasopressin and its influence on cardiac output, mean systemic pressure, and venous return resistance measured through cardiopulmonary interactions, according to the approach proposed by Guyton.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- CORVaso is a pharmacological trial which aims to determine the variations of cardiac output during vasopressin infusion in major abdominal surgery patients.
| Arm | Type | Receives |
|---|---|---|
| Continuous vasopressin infusion | Experimental | Drug: Vasopressin, ArginineAfter general anesthesia, patients will receive a continuous infusion of vasopressin in order to improve mean arterial pressure by 20 mmHg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults above 18
- Planned for a major abdominal surgery under general anesthesia
- Under mechanical ventilation
- Presence of a central venous and arterial lines allowing transpulmonary thermodilution cardiac output measurement
- Patient's consent with a social insurance
Key exclusion criteria (17 listed)
- Do not consent to participate
- History of heart attack, arteriopathy or aneurysm
- Contraindication to use transpulmonary thermodilution to measure cardiac output :
- coagulopathy
- cardiac arrythmia
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 |
|---|---|---|
| Vasopressin, ArginineOnce vasopressin infusion started, patients positions will be randomized: Trendelenburg (-30°), anti Trendelenburg (+30°) and supine position (0°). | Drug | Continuous vasopressin infusion |
Primary outcome
Variation of cardiac output after an infusion of vasopressin at different levels of cardiac preload
Time frame: 15 minutes after position change
Using a thermodilution method, cardiac output will be measured and recorded at different levels of cardiac preload obtained by changing patient's position (Trendelenburg, anti-Trendelenburg and supine position).
2 secondary outcomes
Variation of mean systemic filling pressure and venous return after an infusion of vasopressin at different levels of cardiac preload
Time frame: 15 minutes after position change
Variation of central venous pressure after an infusion of vasopressin at different levels of cardiac preload
Time frame: 15 minutes after position change
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 5 Dec 2022.
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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.
Thomas Godet principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vasopressin, Arginine in people with Major Abdominal Surgery and General Anesthesia, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 5 inclusion and 17 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 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Variation of cardiac output after an infusion of vasopressin at different levels of cardiac preload (time frame: 15 minutes after position change). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2022; AzTrials last refreshed its copy on 8 Nov 2026.