Vasopressin or Norepinephrine in Vasoplegic Shock After Non-cardiac Surgery

What Was Tested

The trial (phase 2, phase 3) is built around Vasopressin.

The purpose of the present study is to evaluate the effect of vasopressin compared to norepinephrine on the clinical complications of patients with vasospastic shock after noncardiac surgeries.

It had two arms (groups): Vasopressin group (experimental) and Norepinephrine group (active comparator).

Blinded vasopressin.

Blinded norepinephrine.

The registry classes the interventions as drug.

More on the Plan

The Systemic Inflammatory Response Syndrome (SIRS) is a common complication after non-cardiac surgery, impacting negatively on patient outcome and with high incidence rates.

Vasoplegic syndrome is the most serious complication of SIRS and can happen after any type of surgery.

The etiology of the vasoplegic syndrome has not yet been fully elucidated, but is known to occur more frequently in patients at high surgical risk, submitted to major surgeries, or in the presence of perioperative complications and patients with comorbidities.

In this circumstance, the depletion of vasopressin stocks is described, which may contribute to the refractoriness of the shock and the lack of response to the catecholaminergic drugs.

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 greater than 18 years;. Patients undergoing high-risk non-cardiac surgery;. Signature of the informed consent form.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: allergy to vasoactive drugs;; previous use of vasopressor;; presence of raynaud's phenomenon, altered allen's test, systemic sclerosis or vasospastic diathesis;.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Vasopressin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Vasopressin.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2019-01 with completion listed for 2023-10-02.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Incidence between groups of a composite outcome of all-cause mortality, cardiovascular and renal complications after high-risk non-cardiac surgeries (time frame: 30 days).

It also tracked 14 secondary outcomes, for example All-cause mortality, Acute myocardial infarction, Cardiogenic shock, Ventricular and / or supraventricular arrhythmia, Acute respiratory distress syndrome (ARDS) and Stroke and transient ischemic attack.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, 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.