Septic ShockPhase 3SAVSepticShockNCT07052084
Systematic Adjunction of Vasopressine in Septic Shock
A Phase 3 study testing Vasopressin administration and Sodium chloride administration in people with Septic Shock, run by Assistance Publique Hopitaux De Marseille at 3 sites in France.
Trial summary
Septic shock is a syndrome associated with severe infection and a mortality rate of approximately 45%. In line with current recommendations, norepinephrine is the first-line vasopressor used in patients with septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Vasopressin administration and Sodium chloride administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesFrance
- Study dates
- 24 Mar 2026to Feb 2028
- Phase
- Phase 3
- 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
Who may be able to join
- Patient aged 18 or over
- Patient who has consented to take part in the research or patient whose close relative has consented to take part in the research or, failing that, patient being included in an emergency situation
- Patient in septic shock with adapted cardiac output
- Patient in whom noradrenaline dosage has been greater than 0.3μg/kg/min for less than 12 hours
- Patients benefiting from or affiliated to social security
Who cannot join
- Patient with acute coronary syndrome
- Patient with known history of acute coronary syndrome
- Patient with suspected mesenteric ischemia
- Patient with hyponatremia < 130mmol/L,
- Known allergy to vasopressin or its excipients
- Minors
Show all 9Show fewer
- Pregnant women
- Patients under legal guardianship or curatorship
- Patients under judicial protection.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, 13100
Aurélien Culver, MD, 04 42 33 50 00 ext. +33, aurelien.culver@gmail.com
Aurélien Culver, MD
- Recruiting
Assistance Publique - Hôpitaux de Marseille
Marseille, 13005
Gary Duclos, MD, 04 91 96 55 31 ext. +33, gary.duclos@ap-hm.fr
Gary Duclos, MD
- Recruiting
CHU de Nîmes - Carémeau
Nîmes, 30029
Laurent Muller, MD-PH, 04 66 68 68 68 ext. +33, laurent.muller@chu-nimes.fr
Laurent Muller, MD-PH
About this study
Official title: Systematic Adjunction of Vasopressine in Hyperkinetic Septic Shock Patients - A Multicentric RCT
Septic shock is a syndrome associated with severe infection and a mortality rate of approximately 45%. In line with current recommendations, norepinephrine is the first-line vasopressor used in patients with septic shock. In a previous study, norepinephrine doses above 1 µg/kg/min were associated with mortality rates over 90%. In the same study, doses above 0.3 µg/kg/min were associated with a mortality rate of 40%. An increased mortality compared to the general 40% mortality of septic shock appears to be associated with norepinephrine doses as low as 0.3 µg/kg/min.
Vasopressin stimulates V1 receptors, primarily located on vascular smooth muscle cells. When V1a receptors are stimulated, they induce vasoconstriction by activating protein kinase C via a Gq protein and various second messengers.
Read more
Its use is validated in refractory shock states by international guidelines as a second-line vasopressor. This indication was further reinforced in the 2021 update of the septic shock management recommendations.
The VASST study, a randomized controlled trial, assessed the effects of vasopressin versus norepinephrine in septic shock. It found no overall difference in mortality between the two groups. However, in less severe cases where norepinephrine doses were below 14 µg/min before randomization, vasopressin was associated with significantly lower mortality, suggesting potential benefits from early introduction of a second vasopressor.
The VANISH trial failed to confirm this hypothesis, possibly due to broad inclusion criteria and unclear protocol regarding the combined use of both agents. Our hypothesis is that (1) vasopressin is beneficial when used synergistically with norepinephrine; (2) due to its negative effect on cardiac output (as shown in previous studies), vasopressin should only be administered to patients in the hyperdynamic phase of septic shock.
The hypothesis is that the systematic addition of vasopressin to norepinephrine therapy in a hyperdynamic septic shock subpopulation would improve patient outcomes.
- Conditions
- Septic Shock
- Being tested
- Vasopressin administration, Sodium chloride administration
- Keywords
- Vasopressine, Systematic adjunction
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vasopressin administrationDrug
Low dose of vasopressin (0.02ui /min), maximum 5 days
Sodium chloride administrationDrug
NaCl 0.9 %, maximum 5 days
| Study group | Role | What they receive |
|---|---|---|
| Vassopressine | Experimental | Not described Receives: Drug: Vasopressin administration |
| Placebo | Placebo comparator | Not described Receives: Drug: Sodium chloride administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOFA score comparison between the two groups
Sepsis-related Organ Failure Assessment, 0 to 24 points (higher scores indicate more severe organ dysfunction)
Measured: 48 hours after administration of experimental drug (H48)
Secondary outcomes (12)
SOFA score comparison between the two groups
Sepsis-related Organ Failure Assessment, 0 to 24 points (higher scores indicate more severe organ dysfunction)
Measured: 120 hours after administration of experimental drug (H120)
Mortality comparison between the two groups
Measured: 28 days after administration of experimental drug (D28)
Lactatemia decrease comparison between the two groups
Measured: Between administration of experimental drug (H0), 24 hours after (H24), and 48 hours after (H48)
Noradrenaline use comparison between the two groups
Maximum dose
Measured: 5 days after administration of experimental drug (D5)
Renal function comparison between the two groups
Number of days alive without renal replacement therapy
Measured: 28 days after administration of experimental drug (D28)
Respiratory function comparison between the two groups
Number of days alive without mechanical ventilation
Measured: 28 days after administration of experimental drug (D28)
Occurrence of myocardial ischemia comparison between the two groups
Measured: 28 days after administration of experimental drug (D28)
Occurrence of cardiogenic shock comparison between the two groups
Measured: 28 days after administration of experimental drug (D28)
Occurrence of mesenteric ischemia comparison between the two groups
Measured: 28 days after administration of experimental drug (D28)
Occurrence of digital ischemia comparison between the two groups
Measured: 28 days after administration of experimental drug (D28)
Occurrence of atrial fibrillation comparison between the two groups
Measured: 28 days after administration of experimental drug (D28)
Occurrence of a thromboembolic event comparison between the two groups
Measured: 28 days after administration of experimental drug (D28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start24 Mar 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Crémieux, Study director, Assistance Publique - Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052084
- Sponsor's protocol ID
- RCAPHM23_0465
- Other IDs
- 2024-513401-31-00
- Acronym
- SAVSepticShock
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Adjunction of Vasopressine in Hyperkinetic Septic Shock Patients - A Multicentric RCT
- ClinicalTrials.gov ID
- NCT07052084
- Acronym / sponsor ID
- SAVSepticShock / RCAPHM23_0465
- Conditions
- Septic Shock
- Keywords
- Vasopressine, Systematic adjunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 4 Jul 2025 (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.
Septic shock is a syndrome associated with severe infection and a mortality rate of approximately 45%. In line with current recommendations, norepinephrine is the first-line vasopressor used in patients with septic shock. In a previous study, norepinephrine doses above 1 µg/kg/min were associated with mortality rates over 90%. In the same study, doses above 0.3 µg/kg/min were associated with a mortality rate of 40%. An increased mortality compared to the general 40% mortality of septic shock appears to be associated with norepinephrine doses as low as 0.3 µg/kg/min.
Vasopressin stimulates V1 receptors, primarily located on vascular smooth muscle cells. When V1a receptors are stimulated, they induce vasoconstriction by activating protein kinase C via a Gq protein and various second messengers.
Its use is validated in refractory shock states by international guidelines as a second-line vasopressor. This indication was further reinforced in the 2021 update of the septic shock management recommendations.
The VASST study, a randomized controlled trial, assessed the effects of vasopressin versus norepinephrine in septic shock. It found no overall difference in mortality between the two groups. However, in less severe cases where norepinephrine doses were below 14 µg/min before randomization, vasopressin was associated with significantly lower mortality, suggesting potential benefits from early introduction of a second vasopressor.
The VANISH trial failed to confirm this hypothesis, possibly due to broad inclusion criteria and unclear protocol regarding the combined use of both agents. Our hypothesis is that (1) vasopressin is beneficial when used synergistically with norepinephrine; (2) due to its negative effect on cardiac output (as shown in previous studies), vasopressin should only be administered to patients in the hyperdynamic phase of septic shock.
The hypothesis is that the systematic addition of vasopressin to norepinephrine therapy in a hyperdynamic septic shock subpopulation would improve patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vassopressine | Experimental | Drug: Vasopressin administration |
| Placebo | Placebo comparator | Drug: Sodium chloride administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged 18 or over
- Patient who has consented to take part in the research or patient whose close relative has consented to take part in the research or, failing that, patient being included in an emergency situation
- Patient in septic shock with adapted cardiac output
- Patient in whom noradrenaline dosage has been greater than 0.3μg/kg/min for less than 12 hours
- Patients benefiting from or affiliated to social security
Key exclusion criteria (9 listed)
- Patient with acute coronary syndrome
- Patient with known history of acute coronary syndrome
- Patient with suspected mesenteric ischemia
- Patient with hyponatremia < 130mmol/L,
- Known allergy to vasopressin or its excipients
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 administrationLow dose of vasopressin (0.02ui /min), maximum 5 days | Drug | Vassopressine |
| Sodium chloride administrationNaCl 0.9 %, maximum 5 days | Drug | Placebo |
Primary outcome
SOFA score comparison between the two groups
Time frame: 48 hours after administration of experimental drug (H48)
Sepsis-related Organ Failure Assessment, 0 to 24 points (higher scores indicate more severe organ dysfunction)
12 secondary outcomes
SOFA score comparison between the two groups
Time frame: 120 hours after administration of experimental drug (H120)
Mortality comparison between the two groups
Time frame: 28 days after administration of experimental drug (D28)
Lactatemia decrease comparison between the two groups
Time frame: Between administration of experimental drug (H0), 24 hours after (H24), and 48 hours after (H48)
Noradrenaline use comparison between the two groups
Time frame: 5 days after administration of experimental drug (D5)
Renal function comparison between the two groups
Time frame: 28 days after administration of experimental drug (D28)
Respiratory function comparison between the two groups
Time frame: 28 days after administration of experimental drug (D28)
Occurrence of myocardial ischemia comparison between the two groups
Time frame: 28 days after administration of experimental drug (D28)
Occurrence of cardiogenic shock comparison between the two groups
Time frame: 28 days after administration of experimental drug (D28)
Occurrence of mesenteric ischemia comparison between the two groups
Time frame: 28 days after administration of experimental drug (D28)
Occurrence of digital ischemia comparison between the two groups
Time frame: 28 days after administration of experimental drug (D28)
Occurrence of atrial fibrillation comparison between the two groups
Time frame: 28 days after administration of experimental drug (D28)
Occurrence of a thromboembolic event comparison between the two groups
Time frame: 28 days after administration of experimental drug (D28)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
Recruiting
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
RecruitingObservational study
Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
Sepsis
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.
François Crémieux study director
Assistance Publique - Hôpitaux de Marseille
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vasopressin administration and Sodium chloride administration in people with Septic Shock, run by Assistance Publique Hopitaux De Marseille at 3 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 9 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Gary Duclos, MD (04 91 96 55 31 ext. +33, gary.duclos@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SOFA score comparison between the two groups (time frame: 48 hours after administration of experimental drug (H48)). 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 26 Oct 2026.