Cardiac Output Response to Vasopressin Infusion In Abdominal Surgery Patients Under Mechanical Ventilation

NCT04935814 | Completed Phase 4

• 1 other identifier: CORVaso / RBHP 2021 GODET 2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Abdominal Surgery; General Anesthesia; Mechanical Ventilation; Vasopressin Infusion

Keywords

Vasopressin; Argipressin; Cardiac Output; General Anesthesia; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• Variation of cardiac output after an infusion of vasopressin at different levels of cardiac preload

  Using a thermodilution method, cardiac output will be measured and recorded at different levels of cardiac preload obtained by changing patient's position (Trendelenburg, anti-Trendelenburg and supine position).

  15 minutes after position change

Secondary Outcomes (2)

• Variation of mean systemic filling pressure and venous return after an infusion of vasopressin at different levels of cardiac preload

  15 minutes after position change

• Variation of central venous pressure after an infusion of vasopressin at different levels of cardiac preload

  15 minutes after position change

Study Arms (1)

Continuous vasopressin infusion

EXPERIMENTAL

After general anesthesia, patients will receive a continuous infusion of vasopressin in order to improve mean arterial pressure by 20 mmHg.

Drug: Vasopressin, Arginine

Interventions

Vasopressin, Arginine DRUG

Once vasopressin infusion started, patients positions will be randomized: Trendelenburg (-30°), anti Trendelenburg (+30°) and supine position (0°).

Continuous vasopressin infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Do not consent to participate
• History of heart attack, arteriopathy or aneurysm
• Contraindication to use transpulmonary thermodilution to measure cardiac output :
• coagulopathy
• cardiac arrythmia
• presence of pace-maker or defibrillator
• severe valvulopathy
• Patients with Acute Respiratory Distress Syndrome (according to Berlin criteria)
• History of arterial hypertension (treated or not)
• History of seizure, chronic headache, asthma or heart failure
• Left Ventricular Ejection Fraction (LVEF) \< 45% or right ventricular dysfunction
• History of pulmonary lobectomy or surgery
• History of restrictive or obstructive pulmonary disease
• Body Mass Index (BMI) \< 15 or \> 40 kg/m²
• Pregnancy

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Diabetes Insipidus

Interventions

Arginine Vasopressin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Thomas Godet

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Patients are under general anesthesia and outcomes assessor (statistician) will be blinded of patients positions orders. Sequential positions of patients will be randomized.
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: CORVaso is a pharmacological trial which aims to determine the variations of cardiac output during vasopressin infusion in major abdominal surgery patients.

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 23, 2021
• Study Start: June 9, 2021
• Primary Completion: August 2, 2022
• Study Completion: August 2, 2022
• Last Updated: December 5, 2022

Record last verified: 2022-12

Locations

FR (1)