Using vasopressin as a second vasopressor in adult septic shock patients
Use of Vasopressin in Septic Shock.
Hospital General Universitario Gregorio Marañon · NCT07255378
This observational project will see if starting vasopressin earlier, based on the norepinephrine dose, helps adults in ICUs with septic shock.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital General Universitario Gregorio Marañon (other) |
| Locations | 12 sites (Terrassa, BARCELONA and 11 other locations) |
| Trial ID | NCT07255378 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter observational study of critically ill adults (≥18 years) admitted to ICU with septic shock who receive vasopressin in addition to norepinephrine. Investigators will record the norepinephrine dose at vasopressin initiation and collect daily clinical data during the ICU stay using a pseudonymized REDCap database. The main comparisons focus on timing of vasopressin initiation (defined by norepinephrine dose) and relationships with mortality, renal function, and progression of organ dysfunction. No experimental interventions are assigned — treatments follow local clinical practice and are observed for outcome associations.
Who should consider this trial
Good fit: Adults (age ≥18) admitted to a participating ICU with septic shock who require norepinephrine and receive vasopressin as an adjunct, and who are not excluded by pregnancy, ischemic cardiogenic shock, acute intestinal ischemia, or ICU readmission, are eligible.
Not a fit: Patients who are pediatric, never require vasopressors, have primary ischemic cardiogenic shock, are pregnant, have acute intestinal ischemia, or are ICU readmissions are not expected to benefit from inclusion in this observational project.
Why it matters
Potential benefit: If earlier vasopressin initiation is linked to lower death or less kidney and organ injury, the findings could help clinicians choose the best timing for adding vasopressin and improve outcomes.
How similar studies have performed: Prior randomized trials (for example VASST and VANISH) have tested vasopressin as an adjunct vasopressor with mixed results, leaving the optimal timing and subgroup benefits uncertain.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Terrassa, BARCELONA and 11 other locations
- Consorci Sanitari de Terrassa — Terrassa, BARCELONA, Spain (RECRUITING)
- Hospital Universitario de Getafe — Getafe, Madrid, Spain (RECRUITING)
- Hospital Universitario La Princesa — Madrid, Madrid, Spain (RECRUITING)
- Hospital General Universitario Gregorio Marañón — Madrid, Madrid, Spain (RECRUITING)
- Hospital Universitario Ramón y Cajal — Madrid, Madrid, Spain (RECRUITING)
- Hospital Universitario Clínico San Carlos — Madrid, Madrid, Spain (RECRUITING)
- Hospital Universitario Doce de Octubre — Madrid, Madrid, Spain (RECRUITING)
- Hospital Universitario La Paz — Madrid, Madrid, Spain (RECRUITING)
- Hospital Universitario Puerta de Hierro — Majadahonda, Madrid, Spain (RECRUITING)
- Hospital Universitario Rey Juan Carlos — Móstoles, Madrid, Spain (RECRUITING)
- Hospital Universitario y Politécnico de La Fe — Valencia, Valencia, Spain (RECRUITING)
- Hospital Universitario Miguel Servet — Zaragoza, ZARAGOZA, Spain (RECRUITING)
Study contacts
- Study coordinator: Jamil Antonio Cedeño Mora
- Email: jamilantonio.cedeno@salud.madrid.org
- Phone: +34 630 03 65 02
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Septic Shock, Norepinephrine, Dose Threshold, Intensive Care Unit, Arginine Vasopressin Initiation