Microcirculation Recruitment Using Albumin 20% and Terlipressin in Septic Patients

What Was Tested

This registered phase 1 trial tested Terlipressin.

It had two arms (groups): Group AT (active comparator) and Controlled (placebo comparator).

Will receive the routine management of septic shock patients as culture-based IV antibiotics, IV fluids and intropic support plus a placebo (as lactated ringer solution in the same infusion rates for blinding).

The registry classes the interventions as drug.

More on the Plan

Sepsis is one of the major medical problems and is responsible for high morbidity and mortality.

Surviving Sepsis Campaign Guideline 2016 introduced 3-hours and 6-hours bundles in management of septic shock.

The 2018 update of the Surviving Sepsis Campaign guidelines introduced the 'Hour-1 Bundle' which recommends treatment with intravenous fluids, measurement of serum lactate concentration as a marker of illness severity, administration of vasopressors, obtaining blood cultures and administering broad-spectrum antibiotics, all within the first hour.

Fluid resuscitation is recommended to be initiated immediately and completed within the first hour.

Who Took Part

Enrollment: 36 planned participants were the target.

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: The presence of septic shock meeting all of the following criteria less than 24 hours:-. Clinically possible or probable or microbiologically confirmed infection taking into account the definitions of the "International Sepsis Forum (ISF)". Despite adequate volume therapy, vasopressors are required to maintain mean arterial pressure (MAP) ≥ 65 mm Hg.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: severe liver disease (child-pugh grade c); chronic renal failure; known hypersensitivity to norepinephrine, terlipressin and human albumin.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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

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

In this single-blind Terlipressin study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2021-10 with completion listed for 2022-09.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean Flow Index 6hs (time frame: 6 hrs).

It also tracked 1 secondary outcome, for example Mean Flow Index 24hs.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of 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 Terlipressin compound page, all human trials.