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NCT07255378·Not applicable·OBSERVATIONAL

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

VasopressinOtherRecruiting

Status

Recruiting

Phase

Not applicable

Enrollment

1,200

Locations

12

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

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

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.

Timeline

From registration to results.

  1. First posted

    Dec 1, 2025

  2. Study start

    Oct 1, 2025

  3. Primary completion

    Oct 31, 2027

  4. Study completion

    Jan 1, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Dec 15, 2025

Outcomes

What the study measures.

Primary outcomes

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

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.

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

12 registered sites.

Spain. Showing up to 24 locations stored in the fast local snapshot.

Consorci Sanitari de Terrassa

Terrassa, BARCELONA, Spain

Hospital Universitario de Getafe

Getafe, Madrid, Spain

Hospital Universitario La Princesa

Madrid, Madrid, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Hospital Universitario Clínico San Carlos

Madrid, Madrid, Spain

Hospital Universitario Doce de Octubre

Madrid, Madrid, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Hospital Universitario Rey Juan Carlos

Móstoles, Madrid, Spain

Hospital Universitario y Politécnico de La Fe

Valencia, Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, ZARAGOZA, Spain

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Vasopressin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsVasopressin trial dashboard →DatabaseVasopressin database entry →ResearchVasopressin research guide →