The Construction and Application of Therapeutic System of Intelligent Decision-Oriented Hemodynamic Organized Therapy for Shock Patients

What Was Tested

The trial (phase 4) is built around Vasopressin.

Informed consent was obtained for inclusion in the study and random assignment into the combination or norepinephrine group.

Contact the research assistant to obtain patient number information and print out the appropriate labels.Notify the ward dispensing nurse to open the experimental drug cassette (placed in the refrigerator 4℃ drug cabinet).

It had two arms (groups): norepinephrine+vasopressin (experimental) and Norepinephrine (placebo comparator).

Norepinephrine+vasopressin.

Norepinephrine.

The registry classes the interventions as drug.

Who Took Part

60 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.

The full record lists 0 inclusion and 13 exclusion criteria; among the exclusions: under 18 years of age; acute coronary syndrome requiring treatment; have been treated with va-ecmo.

How the Study Was Run

It was run as a randomized, single-group and triple-blind study.

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

Blinding on both sides kept the participants and researchers unaware of who received Vasopressin.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

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

It started in 2023-05-01 with completion listed for 2025-01-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 28days-Mortality in ICU (time frame: 28 days). ICU duration (time frame: an average of 1 year).

It also tracked 7 secondary outcomes, for example RVDEA/LVDEA, right ventricular thickness, Tricuspid Annular Plane Systolic Excursion, venous excess ultrasound grading system(VexUS), Intestinal ultrasound score and pulsatility index of the middle cerebral artery.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Vasopressin in 60 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.