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Septic Shock and Use of VasopressinVASO-PHENONCT07697144

Effect of Adding Vasopressin on Cardiac Output, Blood Pressure, Diuresis, and Tissue Perfusion Indices in Patients With Septic Shock

An observational study of Septic Shock and Use of Vasopressin, run by Assistance Publique - Hôpitaux de Paris at 8 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

In patients with septic shock, vasopressin is increasingly used in combination with norepinephrine, but its timing of initiation remains heterogeneous and its clinical hemodynamic effects are still insufficiently characterized. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Septic Shock and Use of Vasopressin
How many people
200 participants
Where
8 sitesFrance
Study dates
1 Aug 2026to 1 Sep 2029
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: Adult patients hospitalized in the intensive care unit for septic shock and with use of vasopressin

Who may be able to join

  • Age ≥ 18 years;
  • Hospitalized in an intensive care unit;
  • Presenting with septic shock according to Sepsis-3 criteria;
  • For whom the treating clinician wishes to initiate vasopressin as second-line therapy as part of routine care;
  • Undergoing hemodynamic monitoring with a PiCCO2 device (Pulsion Medical Systems, Getinge, Feldkirchen, Germany) or pulmonary artery catheterization as part of routine care.

Who cannot join

  • Patient already receiving vasopressin;
  • Pregnancy;
  • Patient under legal protection;
  • Patient unwilling to participate in the study.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xavier MONNET, MD PhD contact

+33(0)145213539

xavier.monnet@aphp.fr

Nicolas FAGE, MD PhD contact

fage.nicolas@gmail.com

8 sites in 1 country

France8 sites
  • CHU d'Angers

    Angers

    Pierre ASFAR, PiAsfar@chu-angers.fr

  • CH de Dieppe

    Dieppe

    Marion BEUZELIN, MBeuzelin@ch-dieppe.fr

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre

    Xavier MONNET, xavier.monnet@aphp.fr

  • GHE, Hôpital Louis Pradel, HCL

    Lyon

    Matthias JACQUET-LAGREZE, matthias.jacquet-lagreze@chu-lyon.fr

  • GHS - Hôpital Lyon Sud, HCL

    Lyon

    Jean-Luc FELLAHI, jean-luc.fellahi@chu-lyon.fr

  • Hôpital Nord, AP-HM

    Marseille

    Marc LEONE, Marc.LEONE@ap-hm.fr

  • CHU Rennes - Site Pontchaillou

    Rennes

    Mathieu LESOUHAITIER, Mathieu.LESOUHAITIER@chu-rennes.fr

  • Hôpital Hautepierre, Hôpitaux Universitaires de Strasbourg

    Strasbourg

    Julien DEMISELLE DEMISELLE, julien.demiselle@chru-strasbourg.fr

Other trials in France

About this study

In patients with septic shock, vasopressin is increasingly used in combination with norepinephrine, but its timing of initiation remains heterogeneous and its clinical hemodynamic effects are still insufficiently characterized. Available data suggest variable responses, which may depend on the hemodynamic phenotype at the time of treatment initiation. In particular, the effects of vasopressin may differ according to the presence of preload dependency, baseline cardiac output, impaired systolic function, or baseline diastolic arterial pressure, reflecting the degree of vasoplegia. In this context, the VASO-PHENO study aims to provide a detailed and dynamic description of the early hemodynamic and clinical effects of vasopressin initiation in septic shock.

To date, no clinical study has systematically and dynamically evaluated the effects of vasopressin on central and peripheral hemodynamic parameters according to the hemodynamic profile at the time of its initiation. Describing these effects appears essential to better understand the variability in clinical responses and to contribute to a more rational and personalized approach to vasopressor escalation in septic shock.

Read the detailed description

In patients with septic shock, hemodynamic profiles are highly heterogeneous. From a pathophysiological perspective, three main hemodynamic phenotypic components may contribute to the septic shock state:

  • preload dependency;
  • impaired myocardial function, leading to a cardiac output that is inadequate to meet oxygen demand;
  • vasoplegia.

In some of these contexts, the introduction of vasopressin, as a pure vasoconstrictor, may be inappropriate or even harmful, by impairing cardiac output or exposing the patient to excessive vasoconstriction and a subsequent risk of ischemia.

Thus:

  • In the presence of impaired myocardial function, defined by reduced cardiac output and/or impaired left ventricular ejection fraction, vasopressin initiation may lead to a decrease in cardiac output;
  • In the presence of vasoplegia, the effects of vasopressin on mean arterial pressure and microcirculatory indices, such as capillary refill time, mottling, and urine output, may vary according to the severity of the initial vasoplegia, notably reflected by diastolic arterial pressure;
  • In the presence of persistent preload dependency, the initiation of a pure vasoconstrictor may either increase cardiac output by increasing venous return, or worsen microcirculatory alterations by enhancing vasoconstriction in a context of hypovolemia.

To date, no study has precisely described the effects of vasopressin on macrocirculatory hemodynamic parameters, including arterial pressure, cardiac output, and central venous pressure, and on routinely assessable microcirculatory parameters, including capillary refill time, mottling, and urine output, according to the different hemodynamic phenotypic components present at the time of vasopressin initiation.

Describing the evolution of these parameters appears essential to better understand the variability in clinical responses and associated outcomes. Such an approach could help identify at-risk profiles and provide objective elements to support a more rational and personalized escalation of vasopressor therapy in septic shock.

Keywords
Septic shock, Vasopressin, Cardiac output, Hemodynamic
Medical subject headings
Shock, Septic, Diabetes Insipidus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To describe and compare the evolution of cardiac index between inclusion and 20 minutes after vasopressin initiation in patients with septic shock, according to hemodynamic profiles identified a posteriori from variables collected at the time of vasopre

    Hemodynamic profiles will not be defined a priori. They will be identified a posteriori using a supervised clustering analysis based on variables measured at inclusion and selected for their pathophysiological relevance:

    • presence of preload dependency at the time of vasopressin initiation (yes/no);
    • cardiac index at inclusion;
    • diastolic arterial pressure at inclusion;
    • left ventricular ejection fraction (LVEF).

    Measured: T0 = inclusion. T20 = 20 minutes after the introduction of the vasopressin

Secondary outcomes (10)
  1. To describe the evolution of cardiac index between inclusion (T0), T1h, T3h, and T24h after vasopressin initiation

    Secondary objectives will be analyzed in the overall population and, for descriptive purposes, according to the hemodynamic profiles identified by clustering analysis and according to age at inclusion. Hemodynamic profiles will not be defined a priori. They will be identified a posteriori using a supervised clustering analysis based on variables measured at inclusion and selected for their pathophysiological relevance:

    • presence of preload dependency at the time of vasopressin initiation (yes/no);
    • cardiac index at inclusion;
    • diastolic arterial pressure at inclusion;
    • left ventricular ejection fraction (LVEF).

    Measured: T0 = inclusion, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin

  2. Change in mean arterial pressure after vasopressin initiation

    Mean arterial pressure will be measured at inclusion before vasopressin initiation and at predefined time points after vasopressin initiation. The evolution of mean arterial pressure will be described in the overall population.

    Measured: T0 = inclusion, T20 = 20 minutes after the introduciton of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin

  3. In patients monitored with a Swan-Ganz® pulmonary artery catheter: to describe the evolution of pulmonary artery occlusion pressure between inclusion (T0), T20, T1h, T3h, and T24h after vasopressin initiation3.

    PAPO will be assessed with a standard occlusion of the ballon in the pulmonary arteries with the use of the Swan Ganz. Secondary objectives will be analyzed in the overall population and, for descriptive purposes, according to the hemodynamic profiles identified by clustering analysis and according to age at inclusion. Hemodynamic profiles will not be defined a priori. They will be identified a posteriori using a supervised clustering analysis based on variables measured at inclusion and selected for their pathophysiological relevance:

    • presence of preload dependency at the time of vasopressin initiation (yes/no);
    • cardiac index at inclusion;
    • diastolic arterial pressure at inclusion;
    • left ventricular ejection fraction (LVEF).

    Measured: T0 = inclusion, T20 = 20 minutes after the introduciton of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin

  4. In patients monitored with a transpulmonary thermodilution device combined with pulse contour analysis (PiCCO®): to describe the evolution of indexed extravascular lung water between inclusion (T0), T20, T1h, T3h, and T24h after vasopressin initiation

    The indexed extravascular lung water will be assessed with a standard thermodilution in patients with PICCO. Hemodynamic profiles will not be defined a priori. They will be identified a posteriori using a supervised clustering analysis based on variables measured at inclusion and selected for their pathophysiological relevance:

    • presence of preload dependency at the time of vasopressin initiation (yes/no);
    • cardiac index at inclusion;
    • diastolic arterial pressure at inclusion;
    • left ventricular ejection fraction (LVEF).

    Measured: T0 = inclusion, T20 = 20 minutes after the introduciton of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin

  5. To describe the evolution of mean arterial pressure between inclusion (T0), T20, T1h, T3h, and T24h after vasopressin initiation, according to diastolic arterial pressure at inclusion.

    Secondary objectives will be analyzed in the overall population and, for descriptive purposes, according to the hemodynamic profiles identified by clustering analysis and according to age at inclusion. Hemodynamic profiles will not be defined a priori. They will be identified a posteriori using a supervised clustering analysis based on variables measured at inclusion and selected for their pathophysiological relevance:

    • presence of preload dependency at the time of vasopressin initiation (yes/no);
    • cardiac index at inclusion;
    • diastolic arterial pressure at inclusion;
    • left ventricular ejection fraction (LVEF).

    Measured: T0 = inclusion, T20 = 20 minutes after the introduciton of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin

  6. Change in urine output during the first 24 hours after vasopressin initiation

    Urine output will be collected every 2 hours during the first 24 hours after vasopressin initiation. The evolution of urine output will be described in the overall population.

    Measured: Urine output will be assessed every 2 hours from the introduction of vasopressine (T0) to 24 hours after the introduction of the vasopressine (T24)

  7. Change in capillary refill time after vasopressin initiation

    Capillary refill time will be assessed at baseline and at predefined time points after vasopressin initiation using a standardized method. The evolution of capillary refill time will be described in the overall population.

    Measured: T0 = inclusion, T20 = 20 minutes after the introduciton of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin

  8. To describe the evolution of the mottling between the introduction of vasopressin (T0), T20, T1h, T3h, and T24h after vasopressin initiation, according to the evolution of the mean arterial pressure, diastolic arterial pressure, and of the cardiac output

    Mottling will be assessed in a standardized way, by the mottling score. The mottling score describe the intensy of the mottling, from 0 (no mottling) to 5 (mottling up to the abdominal skin)

    Measured: T0 = inclusion, T20 = 20 minutes after the introduciton of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin

  9. To describe the evolution of arterial lactate between the introduction of vasopressin (T0), T20, T1h, T3h and T24h after vasopressin initiation, according to the evolution of the mean arterial pressure, diastolic arterial pressure and cardiac output

    Arterial lactate will be assessed by a arterial blood gaz sample, if available at this different time point.

    Measured: T0 = inclusion, T20 = 20 minutes after the introduction of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin

  10. To describe the evolution of the cardiac output between the introduction of vasopressin (T0), T20, T1H, T3h and T24h after vasopressin initiation, according to the initial left ventricular ejection fraction.

    Cardiac output will be assessed with PICCO2 device or pulmonary artery catheterization. Left ventricular ejection fraction will be asssessed before adminstration of the vasopressin.

    Measured: T0 = inclusion, T20 = 20 minutes after the introduction of the vasopressin, T1h = 1 hour after the introduction of the vasopressin, T3h = 3 hours after the introduction of the vasopressin. T24h = 24 hours after the introduction of the vasopressin

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion1 Sep 2029 (estimated)
  4. Study completion1 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07697144
Sponsor's protocol ID
APHP260204
Other IDs
2026-A00568-43
Acronym
VASO-PHENO
Status last verified
Jun 2026
First submitted
22 Jun 2026
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Septic Shock and Use of Vasopressin, run by Assistance Publique - Hôpitaux de Paris at 8 sites 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 4 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: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xavier MONNET, MD PhD (+33(0)145213539, xavier.monnet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To describe and compare the evolution of cardiac index between inclusion and 20 minutes after vasopressin initiation in patients with septic shock, according to hemodynamic profiles identified a posteriori from variables collected at the time of vasopre (time frame: T0 = inclusion. T20 = 20 minutes after the introduction of the vasopressin). 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 13 Jul 2026.

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