Use of Vassopresin in Septic Shock Prospective Multicenter Observational Study With Medication
NCT07255378 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1200
Last updated 2025-12-15
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
Interventions
- 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.
Sponsors & Collaborators
-
Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
collaborator OTHER -
Hospital General Universitario Gregorio Marañon
collaborator OTHER -
Jamil Cedeño Mora
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-01
- Primary Completion
- 2027-10-31
- Completion
- 2028-01-01
- FDA Drug
- Yes
Countries
- Spain
Study Locations
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