Systematic Adjunction of Vasopressine in hyperkinetic Septic Shock patients: a prospective, randomized, double blind study.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Regional De Marseille

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

24 Mar 2026 → ongoing

Decision date (initial)

2025-04-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

DGOS PHRC-I

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Study the effect of adding vasopressin in hyperkinetic septic shock on organ failure.

Secondary objectives 7

1. Compare the 5-day SOFA score between the two groups
2. Compare mortality between the two groups
3. Compare the decrease in lactatemia in the initial phase between the two groups
4. Compare renal function (severity of renal failure, need for extra-renal purification) between the two groups
5. Compare respiratory function (mechanical ventilation) between the two groups
6. Compare the use of noradrenaline between the two groups
7. Compare complications occurring between inclusion and D28 between the two groups

Conditions and MedDRA coding

Septic shock

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patient 18 years of age or older
2. Patient who has consented to participate in the research or patient whose close relative has consented to participate in the research or, failing that, patient being included in an emergency situation
3. Patient in septic shock with adapted cardiac output defined by : a proven or suspected infectious call point justifying antibiotic therapy ; lactatemia > 2.0 mmol/L ; noradrenaline dosage greater than 0.3 µg/kg/min for more than one hour to maintain mean arterial pressure greater than 65 mmHg despite volumetric correction ; adequate cardiac output defined by a cardiac index ≥ 3.0 L/min/m² or central venous oxygen saturation (ScvO2) ≥ 70%
4. Patients whose noradrenaline dosage has been greater than 0.3µg/kg/min for less than 12 hours at the time of inclusion
5. Patients benefiting from or affiliated to a social security system

Exclusion criteria 9

1. Patient moribund at inclusion with noradrenaline dose > 1µg/kg/min
2. Patient with acute coronary syndrome defined by increased troponin and ST-segment elevation on ECG
3. Patients with a known history of recent acute coronary syndrome (< 3 months)
4. Patient with suspected mesenteric ischemia
5. Patients with a known allergy to vasopressin (REVERPLEG 40 I.U./2 mL, dilutable solution for infusion) or to one or more of its excipients
6. Persons who do not speak French
7. Persons unable to read or write
8. Patients covered by articles L. 1121-5 to L. 1121-8 of the French Public Health Code (minors, adults under tutorship or curatorship, patients deprived of their liberty, pregnant or breast-feeding women)
9. Patient with hyponatremia < 130mmol/L

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Difference in SOFA score 48 hours after drug administration between the 2 groups

Secondary endpoints 14

1. SOFA score at D5
2. All-cause mortality in ICU (date of death) and all-cause mortality at D28 (date of death)
3. Plasma lactatemia clearance between introduction of experimental drug (H0) and H24 and H48
4. K-DIGO classification at D28 for severity
5. Use of extrarenal purification at D28 (yes/no), number of days alive without extrarenal purification at D28
6. Number of days alive without mechanical ventilation at D28
7. Maximum dose of noradrenaline during the first 5 days of inclusion defined as the maximum dose of noradrenaline infusion
8. Number of days alive without noradrenaline infusion at D28
9. Occurrence of myocardial ischemia defined as electrocardiogram (ECG) change with ST-segment elevation associated with >100% rise in plasma ultrasensitive troponin concentration, between inclusion and D28
10. Occurrence of cardiogenic shock defined as a left ventricular ejection fraction below 30% and the need to introduce a positive inotropic drug, between inclusion and D28
11. Occurrence of mesenteric ischemia defined as the occurrence of an intestinal vascular disorder requiring surgical management (vascular bypass or stent, digestive resection), between inclusion and D28
12. Occurrence of digital ischemia defined as clinical skin necrosis of the extremities of the upper and lower limbs, between inclusion and D28
13. Occurence of atrial fibrillation defined as irregular tachycardia with fine QRS of atrial origin, between inclusion and D28
14. Occurrence of a thromboembolic event defined by the presence of deep vein thrombosis or pulmonary embolism, between inclusion and D28

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Regional De Marseille

Sponsor organisation

Centre Hospitalier Regional De Marseille

Address

80 Rue Brochier

City

Marseille

Postcode

13005

Country

France

Scientific contact point

Organisation

Centre Hospitalier Regional De Marseille

Contact name

Gary DUCLOS

Public contact point

Organisation

Centre Hospitalier Regional De Marseille

Contact name

Gary DUCLOS

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications