Respiratory Variation in Central Venous Oxygen Saturation Predicts Volume Responsiveness in Hemodynamically Unstable Patients Under Mechanical Ventilation : a Prospective Cohort Study (VOS-HI)

April 29, 2021 updated by: Pr. Semir Nouira, University of Monastir

Vascular filling is the main treatment of hypovolemia. Hypovolemia diagnosis can be difficult in some situations and need to be confirmed with other investigations.

Venous oxymetry based on the ScvO2 values represent a valuable way to predict responsivness to fluid filling maneuver in patients with hemodynamic instability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vascular filling represent the milestone of the treatment of hypovolemia. Its main objective is to restore vascular volume and correct perfusion issues preventing the deleterious consequences of prolonged shock.

Hypovolemia diagnosis is easy to made in obvious clinical situations such as hemorrhagic shock, deshydratation..., but there still many diagnostic difficulties regarding latent hypovolemia especially if associated with left ventricular dysfunction.

In this situations, diagnostic of hypovolemia is hard to made and other investigations are needed.

Central venous pressure (CVP) and pulmonary occlusion artery pressure (PAPO) are the mainly used parameters for indicating vascular filling but actually many studies underline their low liability in this situation.

After vascular filling, outcome measurment is needed to evaluate the efficacity of the treatment.

Outcome measurment based on hemodynamic criteria is still insufficient. In fact, tissue hypoxia persists if the cardio - respiratory system did not adapt to the metabolic needs, that's why a pathway based on therapeutic objectives like venous oxymetry is needed.

Theorically, a filling maneuver is beneficial if associated with a ScvO2 amelioration. It reflects the amelioration of cardiac output and predicts the positive responsivness to the filling test.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Monastir, Tunisia, 6000
        • Emergency department of university hospital Fattouma Bourguiba of Monastir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients aged above 18 year old
  • hemodynamic instability (hypotension or shock)

Exclusion Criteria:

  • intra cardiac shunt
  • severe arrythmia
  • valvular regurgitation
  • pacemaker
  • pulmonary oedema

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: crystalloid solution
vascular filling with 500 ml of crystalloid solution within 10 minutes
Drug: Sodium Chloride 0.9% Intravenous
vascular filling with 500 ml of crystalloid solution (sodium chloride 0.9%) over 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
central venous oxygen saturation (ScvO2) variation
Time Frame: at baseline and after 10 minutes
the ScvO2 is first measured at baseline via a central venous catheter and blood gaz, then after vascular filling (500 ml of colloid solution (Plasmagel) over thirty minutes).
at baseline and after 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Monastir

Investigators

  • Study Director: Nouira Samir, Professor, Research Laboratory (LR12SP18) University of Monastir 5000 Tunisia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 6, 2014

First Submitted That Met QC Criteria

May 19, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Actual)

May 5, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • ScvO2 Flo-Trac study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemodynamic Instability

Clinical Trials on Sodium Chloride 0.9% Intravenous

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe