Cure My Disease

Don't miss your cure!

 Log in / Sign up

New trial tests best timing for sepsis drug to save lives and kidneys

NCT ID NCT06464510

Disease control Sponsor: Hospital do Coracao Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving vasopressin early, along with norepinephrine, is better than waiting to use it as a rescue treatment for people with septic shock. About 2,800 critically ill adults will be randomly assigned to one of two strategies. The main goal is to see which approach reduces the chance of death or the need for kidney dialysis within 28 days.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 2,800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Septic shock are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Critical Illness diabetes insipidus toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Septic shock

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BP-A Beneficiência Portuguesa de São Paulo

    NOT_YET_RECRUITING

    São Paulo, São Paulo, Brazil

  • Hospital Alemão Oswaldo Cruz

    NOT_YET_RECRUITING

    São Paulo, São Paulo, Brazil

  • Hospital Geral de Caxias do Sul

    RECRUITING

    Caxias do Sul, Rio Grande do Sul, Brazil

  • Hospital Nereu Ramos

    RECRUITING

    Florianópolis, Santa Catarina, Brazil

  • Hospital SEPACO

    NOT_YET_RECRUITING

    São Paulo, S, Brazil

  • Hospital São Paulo - UNIFESP

    RECRUITING

    São Paulo, São Paulo, Brazil

  • Hospital de Amor - Unidade Barretos (Fundação PIO XII)

    NOT_YET_RECRUITING

    Barretos, São Paulo, Brazil

  • Hospital do Coracao

    RECRUITING

    São Paulo, São Paulo, 05435000, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.