Use of Vassopresin in Septic Shock Prospective Multicenter Observational Study With Medication (VASO-2024)

December 7, 2025 updated by: Jamil Cedeño Mora

Use of Vasopressin in Septic Shock.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • BARCELONA
      • Terrassa, BARCELONA, Spain, 08227
        • Recruiting
        • Consorci Sanitari de Terrassa
        • Contact:
    • Madrid
      • Getafe, Madrid, Spain, 28905
      • Madrid, Madrid, Spain, 28034
      • Madrid, Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
      • Madrid, Madrid, Spain, 28007
      • Madrid, Madrid, Spain, 28040
      • Madrid, Madrid, Spain, 28041
      • Madrid, Madrid, Spain, 28006
      • Majadahonda, Madrid, Spain, 28222
      • Móstoles, Madrid, Spain, 28933
    • Valencia
      • Valencia, Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitario y Politécnico de La Fe
        • Contact:
    • ZARAGOZA
      • Zaragoza, ZARAGOZA, Spain, 50009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
From patient ICU-admission to 30 days after or patient ICU-discharge.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
From patient ICU-admission to 30 days after or patient ICU-discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jamil Cedeño Mora

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Estimated)

December 1, 2025

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 7, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VASO-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study protocol agreed upon with the supervising authorities explicitly excludes the possibility of doing so.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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