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Cardiac Output Response to Vasopressin Infusion In Abdominal Surgery Patients Under Mechanical Ventilation
Plain-language guide to NCT04935814: phase 4 interventional trial of Vasopressin, 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04935814
- Phase
- phase 4
- Status
- completed
- Start
- 2021-06-09
- Completion (planned or actual)
- 2022-08-02
- Participants
- 20 (actual)
- Design
- na, open label (everyone knows who gets what), basic_science
- Conditions studied
- Major Abdominal Surgery; General Anesthesia; Mechanical Ventilation; Vasopressin Infusion
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Vasopressin.
In this study, the investigators propose to explore the hemodynamic variations induced by vasopressin and its influence on cardiac output, mean systemic pressure, and venous return resistance measured through cardiopulmonary interactions, according to the approach proposed by Guyton, in patients undergoing major abdominal surgeries.
It had 1 arm (groups): Continuous vasopressin infusion (experimental).
The registry classes the interventions as drug.
More on the Plan
Maintaining hemodynamic stability is one of the main objectives of the anesthesiologist or the intensivist, either in the ICU or the OR.
This consists of optimizing cardiac output to ensure satisfactory systemic perfusion during the peri-operative period or the ICU stay.
The occurrence of oxygen debt (mismatch between oxygen consumption and transport) and/or tissue hypoperfusion are key factors in the development of organ failure.
Monitoring of cardiac output and stroke volume is a valuable and essential aid in determining the therapies to be used for this optimization, whether it involves volume expansion or the use of a vasopressor or even inotropic agent.
Who Took Part
The registry lists 20 actual participants took part.
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: Adults above 18. Planned for a major abdominal surgery under general anesthesia. Under mechanical ventilation. Presence of a central venous and arterial lines allowing transpulmonary thermodilution cardiac output measurement. Patient's consent with a social insurance.
The full record lists 5 inclusion and 17 exclusion criteria; among the exclusions: do not consent to participate; history of heart attack, arteriopathy or aneurysm; contraindication to use transpulmonary thermodilution to measure cardiac output :.
How the Study Was Run
It was run as a sequential and open-label study.
Nothing was hidden in this open-label Vasopressin study: the participants and staff both knew the treatment.
It started in 2021-06-09 with completion listed for 2022-08-02.
It ran at 1 site in France.
Its stated primary purpose is basic science.
What Was Measured
Primary outcome: Variation of cardiac output after an infusion of vasopressin at different levels of cardiac preload (time frame: 15 minutes after position change).
It also tracked 2 secondary outcomes, for example Variation of mean systemic filling pressure and venous return after an infusion of vasopressin at different levels of cardiac preload and Variation of central venous pressure after an infusion of vasopressin at different levels of cardiac preload.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Vasopressin in 20 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; 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.