Ireland
--:--IST
Latest
Clinical Trials in Spain / NCT07255378
Recruiting Observational

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

NCT07255378 · tracked via the Priya Life Science Spain tracker
Sponsor
Jamil Cedeño Mora
Phase
Observational
Started
2025-10-01
Last updated
2025-12-15

Condition(s) studied

Septic Shock

Investigational drug(s) / intervention(s)

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

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
Consorci Sanitari de Terrassa Terrassa BARCELONA Recruiting
Hospital Universitario de Getafe Getafe Madrid Recruiting
Hospital Universitario La Princesa Madrid Madrid Recruiting
Hospital General Universitario Gregorio Marañón Madrid Madrid Recruiting
Hospital Universitario Ramón y Cajal Madrid Madrid Recruiting
Hospital Universitario Clínico San Carlos Madrid Madrid Recruiting
Hospital Universitario Doce de Octubre Madrid Madrid Recruiting
Hospital Universitario La Paz Madrid Madrid Recruiting
Hospital Universitario Puerta de Hierro Majadahonda Madrid Recruiting
Hospital Universitario Rey Juan Carlos Móstoles Madrid Recruiting
Hospital Universitario y Politécnico de La Fe Valencia Valencia Recruiting
Hospital Universitario Miguel Servet Zaragoza ZARAGOZA Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07255378 on ClinicalTrials.gov ↗ ← All trials in Spain