Use of Vassopresin in Septic Shock Prospective Multicenter Observational Study With Medication

NCT07255378 | Recruiting FDA Drug

• 1 other identifier: VASO-2024
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 12

Brief Summary

The aim of this observational study is to examine real-world clinical practice regarding the use of vasopressin as a second-line vasopressor in adult patients admitted to Intensive Care Units (ICUs) with septic shock. The study focuses on critically ill adults (≥18 years) diagnosed with septic shock and treated with norepinephrine and vasopressin. The main research questions are:

• Does early initiation of vasopressin-defined by the norepinephrine dose at the time of introduction-reduce mortality in patients with septic shock?
• What is the impact of vasopressin as a second vasopressor on renal function and the progression of organ dysfunction in septic shock patients? Participants will:
• Be admitted to an ICU with a diagnosis of septic shock.
• Receive vasopressin as an adjunct to norepinephrine for hemodynamic support.
• Be monitored daily throughout their ICU stay, with data collected through a dedicated REDCap system.
• Have relevant clinical data pseudonymized and incorporated into the study database for statistical analysis.

Conditions

Septic Shock

Keywords

Norepinephrine; Septic Shock; Dose Threshold; Intensive Care Unit; Arginine Vasopressin Initiation

Outcome Measures

Primary Outcomes (1)

• Prognostic impact, in terms of all-cause mortality, of early VAP initiation in patients with septic shock.

  From patient ICU-admission to 30 days after or patient ICU-discharge.

Secondary Outcomes (2)

• Impact of vasopressin usage as a second vasopressor on renal function.

  From patient ICU-admission to 30 days after or patient ICU-discharge.

• Impact of VAP use as a second vasopressor on the progression of organ dysfunction.

  From patient ICU-admission to 30 days after or patient ICU-discharge.

Interventions

Usage of vasopressin (VAP) as a second-line vasopressor in septic shock patients. DRUG

A state-of-the-art line of research in septic shock management focuses on the potential use of a second vasopressor agent. Current efforts aim to determine which drug should be used and the optimal timing for its initiation. In line with this, the Surviving Sepsis Campaign 2021 clinical guide recommends considering vasopressin-arginine (VAP) as a second-line vasopressor when norepinephrine (NAD) doses exceed 0.25 µg/kg/min, although this suggestion is based on limited evidence and remains weak.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU-admitted patients treated at Spanish public hospitals participating in the study.

Eligible patients for this study must comply with the following requirements. * ICU admission with a septic shock diagnosis. * Age 18 years or above at ICU admission. * Use of vasopressin as an adjunct of norepinephrine. For the purposes of this study, septic shock is defined by full compliance with the following criteria. * Sustained arterial hypotension or serum lactate above 2 mmol/L. * Adequate but unsuccessful fluid resuscitation. * Vasopressor usage to maintain a mean arterial pressure above 65 mmHg. * Probable or proven infectious etiology. Patients with some of the following conditions will be automatically excluded. * Pregnancy. * Ischemic cardiogenic shock. * Acute intestinal ischemia. * Readmission to the Intensive Care Unit.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jamil Cedeño Mora: lead
• Fundación para la Investigación Biomédica del Hospital Gregorio Maranon: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator

Study Sites (12)

Consorci Sanitari de Terrassa

Terrassa, BARCELONA, 08227, Spain

RECRUITING

Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

RECRUITING

Hospital Universitario La Princesa

Madrid, Madrid, 28006, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

RECRUITING

Hospital Universitario Clínico San Carlos

Madrid, Madrid, 28040, Spain

RECRUITING

Hospital Universitario Doce de Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

RECRUITING

Hospital Universitario Rey Juan Carlos

Móstoles, Madrid, 28933, Spain

RECRUITING

Hospital Universitario y Politécnico de La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, ZARAGOZA, 50009, Spain

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Jamil Antonio Cedeño Mora

CONTACT

+34 630 03 65 02; jamilantonio.cedeno@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant in Intensive Care Medicine. Head of Hemodynamics in the Intensive Care Unit.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (12)