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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 10 May 2021
Main ID:  NCT02142985
Date of registration: 06/05/2014
Prospective Registration: No
Primary sponsor: University of Monastir
Public title: Respiratory Variation in Central Venous Oxygen Saturation Predicts Volume Responsiveness in Hemodynamically Unstable Patients Under Mechanical Ventilation : a Prospective Cohort Study VOS-HI
Scientific title: Respiratory Variation in Central Venous Oxygen Saturation Predicts Volume Responsiveness in Hemodynamically Unstable Patients Under Mechanical Ventilation : a Prospective Cohort Study
Date of first enrolment: April 2014
Target sample size: 88
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02142985
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Tunisia
Contacts
Name:     Nouira Samir, Professor
Address: 
Telephone:
Email:
Affiliation:  Research Laboratory (LR12SP18) University of Monastir 5000 Tunisia
Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Hemodynamic Instability
Intervention(s)
Drug: Sodium Chloride 0.9% Intravenous
Primary Outcome(s)
central venous oxygen saturation (ScvO2) variation [Time Frame: at baseline and after 10 minutes]
Secondary Outcome(s)
Secondary ID(s)
ScvO2 Flo-Trac study
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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