Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock

What Was Tested

The trial (not phased) is built around Vasopressin.

The aim of the work is to compare the effect of norepinephrine alone and Norepinephrine/vasopressin combination on hemodynamics and tissue perfusion in septic shock patients.

It had two arms (groups): NE (active comparator) and NE/VP (active comparator).

The registry classes the interventions as drug.

More on the Plan

Study which was performed on 90 adult of either sex in intensive care unit who developed septic shock.45 patients in each group according to the drugs used, by the single blind technique as the treating physician only is aware of the drugs used.

A comparison was done between both groups as regard:Hemodynamics,Tissue perfusion, C-Reactive Protein (mg/L) ,WBC, UREA (mg/dL),CREATININE (mg/dl), NGAL (Neutrophil gelatinase associated Lipocalin) (ng/ml).

Comparison was done at baseline, then every 6 hours for 48 h as regard hemodynamics and tissue perfusion, and at base line then, 24 h and 48 h as regard sepsis biomarkers and renal biomarkers.

Who Took Part

90 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Age \> 18 years of both sex.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: sever heart disease (ischemic/valvular); peripheral vascular disease (e.g. raynaud's phenomenon).

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

The participants were allocated by chance, so the Vasopressin group and the comparison group should start out alike.

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

As a double-blind Vasopressin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2018-01-01 with completion listed for 2019-01-05.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Lactate Level Lactate level • (central venous oxygen saturation)SVO2 (time frame: 48 hours). Scvo2 (time frame: 48 hours).

It also tracked 3 secondary outcomes, for example NGAL, NGAL NGAL, Mortality and CRP.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vasopressin in 90 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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