The Effect of Restrictive Fluid and Vasopressin During Surgery of Burn Patients

What Was Tested

This registered not phased trial tested Vasopressin.

It had two arms (groups): Control group (no intervention) and Restrictive group (experimental).

The registry classes the interventions as drug.

More on the Plan

This is a randomized double-blinded study to investigate the effect of fluid restriction and vasopressin on blood loss during surgery of the burn patients.

Who Took Part

158 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: Age ≥ 18 years old.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: age \< 18 years old; history of renal disorder; history of cardiac disorder.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Vasopressin and who got the comparison, which limits bias.

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

As a double-blind Vasopressin 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 2018-07-25 with completion listed for 2019-06-04.

It ran at 1 site in South Korea.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Intraoperative blood loss (time frame: At the end of the surgery, approximately 3 hrs).

It also tracked 4 secondary outcomes, for example Intraoperative red blood cell transfusion, Postoperative pulmonary complication, Postoperative cardiovascular complication and Postoperative renal complication.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vasopressin in 158 people.

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

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