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Effect of Vasopressin vs Norepinephrine on Pulmonary Oxygenation and Lung Mechanics in Patients With Hypertension Therapy During One-lung Ventilation : Preliminary Study

Plain-language guide to NCT04170751: not phased randomized trial of Vasopressin, 40 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04170751
Phase
not phased
Status
status unknown
Start
2019-11-18
Completion (planned or actual)
2021-09
Participants
40 (estimated)
Design
randomized, triple-blind, treatment
Conditions studied
Hypertension
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Vasopressin.

It had two arms (groups): group N (experimental) and group V (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 40 planned participants were the target.

It was open to people of any sex aged from 40 years up to 80 years.

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

Examples of who could join: Adult patients aged 40-80 years who are planning to have thoracoscopic single lobectomy with unilateral lung ventilation during surgery. Patients taking hypertension drug CCB(calcium channel blocker), ARB(angiotensin II receptor blocker), ACEi(ACE inhibitor, angiotensin converting enzyme inhibitor) at least 4 weeks. American Society of Anesthesiologists (ASA) classification 2\~3.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: patients with heart failure (nyha class iii\~iv); patients who are having moderate obstructive lung disease or restrictive lung disease; patients with pulmonary hypertension (mean pap\>25mmhg).

How the Study Was Run

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

Because people in this Vasopressin 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 Vasopressin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2019-11-18 with completion listed for 2021-09.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): PaO2/FiO2 ratio (time frame: about 20 minutes after reaching to the target blood pressure (T2)).

It also tracked 3 secondary outcomes, for example lung mechanics: lung compliance, lung mechanics: dead space and lung mechanics: airway pressure.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vasopressin in 40 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.

Our Notes on the Compound

Vasopressin: A 9-amino-acid hormone (antidiuretic hormone) that controls water balance and blood vessel tone; used in septic shock.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.