Hypertonic Saline and Terlipressin for Sepsis-associated Hypotension

What Was Tested

In this phase 3 trial, researchers set out to test Terlipressin.

The appropriate design for this trial would be factorial.

For the time being, will consider de intervention as a whole unit for this pilot study.

It had two arms (groups): Hypertonic Saline and Terlipressin (experimental) and Normal Saline and norepinephrine (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 21 actual participants took part.

It was open to people of any sex aged from 18 years up to 90 years.

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

Examples of who could join: Criteria of SIRS: at least 2 of 4:. Temperature \> 38 °c or \< 36 ° C. More than 90 bpm heart rate. Respiratory rate more than 20rpm or PaCO2 less than 32 mm Hg or patient in mechanical ventilation. MAP less than 70 mm Hg. Note there is no requirement for adequate preload evidence.

The full record lists 8 inclusion and 8 exclusion criteria; among the exclusions: hypernatremia at base-line of 155 meq/l or greater hyponatremia at base-line less than 130meq / l; prior endocrine disease affecting to the adrenal-pituitary axis; intracranial hypertension, brain tumor, seizures, head trauma.

How the Study Was Run

The set-up was 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.

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

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 2012-06 with completion listed for 2013-12.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: MOD (Multiple Organ Dysfunction) Score (time frame: daily, as long as the patient stays in the ICU).

It also tracked 6 secondary outcomes, for example Hypertonic Saline restores IV fluid response parameters (Pulse Pressure Variation or Systolic Volume Variation) adequately, There is an inverse relationship between plasma sodium and plasma procalcitonin levels measured by a negative Pearson coefficient and Hypertonic Saline use rises levels of cortisol but not of adrenocorticotropic hormone (ACTH).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Terlipressin in 21 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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