Hemodynamic InstabilityPhase 2VOS-HINCT02142985
Respiratory Variation in Central Venous Oxygen Saturation Predicts Volume Responsiveness in Hemodynamically Unstable Patients Under Mechanical Ventilation : a Prospective Cohort Study
A Phase 2 study testing Sodium Chloride 0.9% Intravenous in people with Hemodynamic Instability, run by University of Monastir at 1 site in Tunisia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Sodium Chloride 0.9% Intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTunisia
- Study dates
- Apr 2014to Oct 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged above 18 year old
- hemodynamic instability (hypotension or shock)
Who cannot join
- intra cardiac shunt
- severe arrythmia
- valvular regurgitation
- pacemaker
- pulmonary oedema
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Emergency department of university hospital Fattouma Bourguiba of Monastir
Monastir, 6000
About this study
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.
Read the 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.
- Conditions
- Hemodynamic Instability
- Being tested
- Sodium Chloride 0.9% Intravenous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Chloride 0.9% IntravenousDrug
vascular filling with 500 ml of crystalloid solution (sodium chloride 0.9%) over 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| crystalloid solution | Experimental | vascular filling with 500 ml of crystalloid solution within 10 minutes Receives: Drug: Sodium Chloride 0.9% Intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
central venous oxygen saturation (ScvO2) variation
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).
Measured: at baseline and after 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Nouira Samir, Professor, Study director, Research Laboratory (LR12SP18) University of Monastir 5000 Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142985
- Sponsor's protocol ID
- ScvO2 Flo-Trac study
- Acronym
- VOS-HI
- Status last verified
- Apr 2021
- First submitted
- 6 May 2014
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Khalil MH, Sekma A, Zhani W, Zorgati A, Ben Soltane H, Nouira S; GREAT Network. Variation in central venous oxygen saturation to assess volume responsiveness in hemodynamically unstable patients under mechanical ventilation: a prospective cohort study. Crit Care. 2021 Jul 13;25(1):245. doi: 10.1186/s13054-021-03683-6. No abstract available.
PubMed 34256822
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Variation in Central Venous Oxygen Saturation Predicts Volume Responsiveness in Hemodynamically Unstable Patients Under Mechanical Ventilation : a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02142985
- Acronym / sponsor ID
- VOS-HI / ScvO2 Flo-Trac study
- Conditions
- Hemodynamic Instability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| crystalloid solution | Experimental | Drug: Sodium Chloride 0.9% Intravenousvascular filling with 500 ml of crystalloid solution within 10 minutes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged above 18 year old
- hemodynamic instability (hypotension or shock)
Key exclusion criteria (5 listed)
- intra cardiac shunt
- severe arrythmia
- valvular regurgitation
- pacemaker
- pulmonary oedema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Chloride 0.9% Intravenousvascular filling with 500 ml of crystalloid solution (sodium chloride 0.9%) over 30 minutes | Drug | crystalloid solution |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Derived from this study: PubMed 34256822Khalil MH, Sekma A, Zhani W, Zorgati A, Ben Soltane H, Nouira S; GREAT Network. Variation in central venous oxygen saturation to assess volume responsiveness in hemodynamically unstable patients under mechanical ventilation: a prospective cohort study. Crit Care. 2021 Jul 13;25(1):245. doi: 10.1186/s13054-021-03683-6. No abstract available.
- official websiteLink provided by the sponsor.
Related trials for Hemodynamic Instability
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nouira Samir, Professor study director
Research Laboratory (LR12SP18) University of Monastir 5000 Tunisia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium Chloride 0.9% Intravenous in people with Hemodynamic Instability, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
central venous oxygen saturation (ScvO2) variation (time frame: at baseline and after 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02142985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.