What Should be the Next Vasopressor for Severe Septic Shock? Methylene Blue or Terlipressin

What Was Tested

This registered phase 3 trial tested Methylene blue (non-peptide stack partner) and Terlipressin.

In refractory septic shock patient, prolong shock correlate with poor outcome due to multiple organ failure.

It had three arms (groups): A (no intervention), B (experimental) and C (experimental).

Standard care septic shock according sepsis bundles.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 60 planned participants were the target.

It was open to people of any sex aged from 15 years with no upper age limit.

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

Examples of who could join: Age \>15 years old. Diagnosis septic shock as SCCM/ACCP.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: known case g6pd deficiency; acute respiratory distress syndrome (ards); hx of drug allergy mb, ne, terlipressin.

How the Study Was Run

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

Because people in this Methylene blue (non-peptide stack partner) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Methylene blue (non-peptide stack partner) group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Methylene blue (non-peptide stack partner) was given.

Those kept unaware of assignments: participant.

It started in 2016-12 with completion listed for 2018-12.

It ran at 1 site in Thailand.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: mortality rate (time frame: 7 days). time to wean of vasopressor (time frame: through complete weaning off vasopressor, an average of 24 hours). ICU duration (time frame: through out off indication need ICU care, an average of 7 days).

It also tracked 3 secondary outcomes, for example hemodynamic parameter: Mean arterial pressure (mmHg), hemodynamic parameter: lactate (mmol/l) and hemodynamic parameter: urine output (ml).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Methylene blue (non-peptide stack partner) and Terlipressin in 60 people.

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.