NOrepinephrine and VasoprEssin Versus Norepinephrine aLone in Critically Ill Patients With Septic Shock

What Was Tested

This registered phase 4 trial tested Vasopressin.

Sepsis, a systemic host response to the invasion of a pathogenic microorganism, may progress to severe sepsis, wherein the patient experiences acute dysfunction in at least one organ system, and further develop into septic shock if the patient cannot regain adequate systemic blood pressure and perfusion after adequate and appropriate fluid resuscitation.

It had two arms (groups): Norepinephrine and vasopressin (active comparator) and Norepinephrine (active comparator).

The registry classes the interventions as drug.

More on the Plan

Recently, the impactful work performed by Rivers and colleagues that established early goal-directed therapy (EGDT) as the standard of care for patients with severe sepsis or septic shock has been compared to usual care in three international trials.

One key aspect of the provision of care to patients with septic shock is the time to initiation and choice of vasoactive agents.

This study will investigate the use of norepinephrine and vasopressin versus norepinephrine alone as the initial vasoactive regimen in critically ill adult patients with septic shock.

Who Took Part

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥18 years (no maximum age). At least 2 of 4 systemic inflammatory response syndrome criteria:. Fever (\>38°C) or hypothermia (\<36°C),. Tachycardia (heart rate \>90 bpm),. Tachypnea (respiratory rate \>20 breaths/min or partial pressure of carbon dioxide \<4.3 kPa) or need for mechanical ventilation,.

The full record lists 9 inclusion and 5 exclusion criteria; among the exclusions: end-stage renal disease requiring long-term dialysis; not expected to be alive within 48 hours of enrollment; receipt of a continuous infusion of vasoactive medication(s) other than use for emergency stabilization of blood pressure (for less than 4 hours).

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The Vasopressin group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Vasopressin study: the participants and staff both knew the treatment.

It started in 2015-11-01 with completion listed for 2017-11-27.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time to goal MAP (time frame: Within 28 days of therapy initiation).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Vasopressin in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vasopressin compound page, all human trials.