Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate

What Was Tested

In this phase 2 trial, researchers set out to test Methylene blue (non-peptide stack partner) and Terlipressin.

A randomized, prospective study comparing methylene blue versus terlipressin in treatment of catecholamines resistant shock in preterm neonate.

It had two arms (groups): Methylene Blue group (Group MB) (active comparator) and Terlipressin Group (Group TP ) (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The study will be an un-blinded, Phase 2, randomized, 1:1, prospective trial comparing methylene blue versus terlipressin in treatment of preterm neonate with catecholamines resistant septic shock the outcome as regard elevation of mean arterial blood pressure will be measured within 72 hours.

Who Took Part

The registry lists 36 planned participants were the target.

It was open to people of any sex.

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

Examples of who could join: Diagnosis of Septic shock according to clinical sepsis score of Tollner and Hematologic Scoring System of Rodwell.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: known case of g6pd deficiency; hx of drug allergy mb, ne, terlipressin; patients with severely impaired renal function.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Methylene blue (non-peptide stack partner) and who got the comparison, which limits bias.

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

Being open-label, the Methylene blue (non-peptide stack partner) study did not mask who received what.

It started in 2019-02-19 with completion listed for 2020-02-19.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example to assess the effect of intervention on survival.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Methylene blue (non-peptide stack partner) and Terlipressin in 36 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page and the Terlipressin compound page, all human trials.