Comparing early vasopressin to norepinephrine for treating septic shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3, multicenter, open-label, randomized controlled trial investigates the effectiveness of early vasopressin initiation versus a rescue strategy using norepinephrine plus vasopressin for critically ill patients suffering from vasopressor dependent sepsis. The study aims to enroll 2,800 adult patients who exhibit hemodynamic dysfunction due to sepsis. Participants will be monitored for their response to the different vasopressor strategies in managing their condition effectively.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with vasopressor dependent sepsis, defined by infection suspicion and antibiotic administration or laboratory confirmed viral infection, plus hypotension with the need of vasopressors for at least one hour;
* Admitted or expected to be admitted to the ICU in the next 12 hours
* Adequate volume resuscitation in the opinion of the attending physician
* Use of norepinephrine \> 0.05μg/Kg/min and ≤ 0.25μg/Kg/min for at least 1 hour and at most 24 hours at the time of inclusion

Exclusion Criteria:

* Use of norepinephrine \> 0.25μg/Kg/min in the last 24 hours, except when administered transiently in the context of sedation for a procedure or the initial phase of volume resuscitation for a period of less than one hour
* Dialysis-dependent chronic kidney disease or acute kidney injury that received renal replacement therapy during current hospitalization or are expected to receive renal replacement therapy in the next 24 hours
* Use of other vasopressors (except norepinephrine) at the moment of inclusion
* Use of vasopressors for sepsis in the last 7 days
* Suspected or confirmed acute mesenteric ischemia
* Anaphylaxis or known hypersensitivity to the study drug
* Expect to die in the next 24 hours
* Medical team not committed to full support at the time of inclusion
* Previous inclusion in the study

Where it's running

• Hospital Geral de Caxias do Sul
  Caxias do Sul, Rio Grande do Sul, Brazil Recruiting
• Hospital Nereu Ramos
  Florianópolis, Santa Catarina, Brazil Recruiting
• Hospital do Coracao
  São Paulo, São Paulo, Brazil Recruiting
• Hospital São Paulo - UNIFESP
  São Paulo, São Paulo, Brazil Recruiting
• Hospital SEPACO
  São Paulo, S, Brazil Not yet recruiting
• Hospital de Amor - Unidade Barretos (Fundação PIO XII)
  Barretos, São Paulo, Brazil Not yet recruiting

Study contacts

• Principal investigator: Bruno M Tomazini, MD — Hcor Research Institute
• Study coordinator: Bruno M Tomazini, MD
• Email: btomazini@hcor.com.br
• Phone: +5511982839173

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.