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NCT Number: NCT07255378

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Consorci Sanitari de Terrassa, Terrassa, BARCELONA, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

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

Secondary outcomes

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

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

    Renal function will be assessed using the Kidney Disease: Improving Global Outcomes (KDIGO) criteria for acute kidney injury (AKI). KDIGO stages range from 0 (no AKI) to 3 (severe AKI), with higher stages indicating worse renal function. KDIGO classification will be recorded at 24, 48, and 72 hours after vasopressin initiation, as well as the highest stage reached during the entire ICU stay.

    In addition to KDIGO staging, the need for renal replacement therapy (RRT) during admission will also be recorded as an indicator of progression to kidney failure.

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

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

    Organ dysfunction will be measured using the Sequential Organ Failure Assessment (SOFA) score, which ranges from 0 (no organ dysfunction) to 24 (severe multi-organ failure). Higher scores indicate worse outcomes. SOFA score will be recorded at 24, 48, and 72 hours after vasopressin initiation, as well as the maximum SOFA score obtained during the ICU stay.

Study contacts

Contact information is provided by the study sponsor or research team.

Jamil Antonio Cedeño Mora

CONTACT

[email protected]

+34 630 03 65 02

Sponsors and collaborators

Lead sponsor

Jamil Cedeño Mora

Other

Collaborators

  • Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
  • Hospital General Universitario Gregorio Marañon

Registry information

Official study title

Use of Vasopressin in Septic Shock.

Acronym: VASO-2024

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 1, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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