Continuos Terlipressin Infusion in Septic Shock

What Was Tested

The trial (not phased) is built around Terlipressin.

It had two arms (groups): terlipressin (experimental) and norepinephrine (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1000 planned participants were the target.

It was open to people of any sex aged from 16 years with no upper age limit.

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

Examples of who could join: Septic shock was defined by the presence of two or more diagnostic criteria for the systemic inflammatory responsesyndrome, proven or suspected infection, and hypotension (exclusion of hypertention other than sepsis).

The full record lists 1 inclusion and 11 exclusion criteria; among the exclusions: organ transplantation;; pregancy or breast-feeding;; malignancy or other irreversible disease or condition for which has a poor prognosis;.

How the Study Was Run

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

Because people in this Terlipressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

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

It started in 2013-01 with completion listed for 2016-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 28-day Mortality (time frame: 28-days).

It also tracked 3 secondary outcomes, for example SOFA score, days alive and free of vasopressor and 90-day mortality.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Terlipressin in 1000 people.

With 1000 participants it is a large trial for this field.

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.