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

Official title

Use of Vasopressin in Septic Shock.

Overview

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

• 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.

Primary outcome measures

• 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 outcome measures (2)

• 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.]
• 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Spain · 12 centers

• Consorci Sanitari de Terrassa — Terrassa
• Hospital Universitario de Getafe — Getafe
• Hospital Universitario La Princesa — Madrid
• Hospital General Universitario Gregorio Marañón — Madrid
• Hospital Universitario Ramón y Cajal — Madrid
• Hospital Universitario Clínico San Carlos — Madrid
• Hospital Universitario Doce de Octubre — Madrid
• Hospital Universitario La Paz — Madrid
• … and 4 more centers

Identifiers

NCT: NCT07255378 · VASO-2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗