HypovolemiaORNCT01826253
Observational Study of Oxygen Delivery During a Fractional Fluid Expansion
An observational study of Hypovolemia and Impaired Oxygen Delivery, run by University Hospital, Caen at 1 site in France.
Trial summary
Fluid expansion during cardiocirculatory insufficiency was helped by cardiac output monitoring. However, the goal of fluid expansion was to increase the oxygen delivery, which consider cardiac output, but also Haemoglobin which decrease during a fluid challenge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypovolemia, Impaired Oxygen Delivery, Cardiac Output, Low
- What is being tested?
- hydroxyethylstarch 130/0.4
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Jun 2014
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mechanically ventilated patients after elective cardiac surgery with oesophageal Doppler for cardiac output monitoring and arterial and venous central line
Who may be able to join
- Adults over 18 years
- Patients in intensive care after cardiac surgery under mechanically ventilation and with oesophageal Doppler
Who cannot join
- Arrythmia
- Pregnancy or childrens
- Patients without cardiac output monitoring with oesophageal Doppler
- Patients without medical indication for fluid expansion
- Urgency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Fluid expansion during cardiocirculatory insufficiency was helped by cardiac output monitoring. However, the goal of fluid expansion was to increase the oxygen delivery, which consider cardiac output, but also Haemoglobin which decrease during a fluid challenge. The maximalization of cardiac output could decrease the oxygen delivery if the haemodilution was too wide. The aim of this study was to describe the oxygen delivery during a fluid expansion conducted for cardiac output maximalization, following actual guidelines.
Read the detailed description
One group of 20 anticipated patients
- Conditions
- Hypovolemia, Impaired Oxygen Delivery, Cardiac Output, Low
- Being tested
- hydroxyethylstarch 130/0.4
- Keywords
- Hypovolemia, Fluid challenge, Fluid expansion, Oxygene delivery, Cardiac output
- Medical subject headings
- Hypovolemia, Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydroxyethylstarch 130/0.4Drug
Bolus of 100ml of HES 130/0.4 repeated until maximization of cardiac output
| Study group | Role | What they receive |
|---|---|---|
| Hypovolemia | Fluid expansion Receives: Drug: hydroxyethylstarch 130/0.4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of oxygen delivery
Retrospective calculation of oxygen delivery (ml.min.m-2)during a fractional fluid expansion every 100ml of hydroxyethyl starch until cardiac output maximalization with oesophageal Doppler and arterial gazes (for PaO2 and Haemoglobin)from arterial line.
Measured: only during the fluid challenge
Secondary outcomes (1)
Study of central venous saturation
Central venous gazes after each mini fluid challenge until cardiac output maximalization, from a central line
Measured: only during the fluid challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypovolemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc-Olivier FISCHER, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826253
- Sponsor's protocol ID
- A12-D37-VOL.13
- Acronym
- OR
- Status last verified
- May 2013
- First submitted
- 20 Mar 2013
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Oxygen Delivery During a Fractional Fluid Expansion
- ClinicalTrials.gov ID
- NCT01826253
- Acronym / sponsor ID
- OR / A12-D37-VOL.13
- Conditions
- Hypovolemia, Impaired Oxygen Delivery, Cardiac Output, Low
- Keywords
- Hypovolemia, Fluid challenge, Fluid expansion, Oxygene delivery, Cardiac output
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Apr 2013 (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.
Fluid expansion during cardiocirculatory insufficiency was helped by cardiac output monitoring. However, the goal of fluid expansion was to increase the oxygen delivery, which consider cardiac output, but also Haemoglobin which decrease during a fluid challenge. The maximalization of cardiac output could decrease the oxygen delivery if the haemodilution was too wide. The aim of this study was to describe the oxygen delivery during a fluid expansion conducted for cardiac output maximalization, following actual guidelines.
Detailed description
One group of 20 anticipated patients
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypovolemia | – | Drug: hydroxyethylstarch 130/0.4Fluid expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated patients after elective cardiac surgery with oesophageal Doppler for cardiac output monitoring and arterial and venous central line
Key inclusion criteria (2 listed)
- Adults over 18 years
- Patients in intensive care after cardiac surgery under mechanically ventilation and with oesophageal Doppler
Key exclusion criteria (5 listed)
- Arrythmia
- Pregnancy or childrens
- Patients without cardiac output monitoring with oesophageal Doppler
- Patients without medical indication for fluid expansion
- Urgency surgery
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 |
|---|---|---|
| hydroxyethylstarch 130/0.4Bolus of 100ml of HES 130/0.4 repeated until maximization of cardiac output | Drug | Hypovolemia |
Primary outcome
Measurement of oxygen delivery
Time frame: only during the fluid challenge
Retrospective calculation of oxygen delivery (ml.min.m-2)during a fractional fluid expansion every 100ml of hydroxyethyl starch until cardiac output maximalization with oesophageal Doppler and arterial gazes (for PaO2 and Haemoglobin)from arterial line.
1 secondary outcome
Study of central venous saturation
Time frame: only during the fluid challenge
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 16 Jun 2014.
Related trials for Hypovolemia
RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
RecruitingObservational study
Role of End-Tidal CO2 During Passive Leg Raising to Predict Fluid Responsiveness in ICU
Circulatory Failure, Critical Illness
RecruitingPhase 4
A Study to Assess the Safety and Efficacy of Centhaquine in Hypovolemic Shock Patients
Hypovolemic Shock
Not yet recruitingObservational study
Inferior Vena Cava Versus Subclavian Vein Collapsibility for Predicting Fluid Responsiveness in Trauma Hemorrhagic Shock
Hemorrhagic Shock, Trauma
Not yet recruitingObservational study
Validation of a Wearable Bioimpedance Sensor for Hydration Monitoring
Dehydration, Hypovolemia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypovolemia and Impaired Oxygen Delivery, run by University Hospital, Caen at 1 site in France.
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 16 Jun 2014. 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 France. 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.
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?
Measurement of oxygen delivery (time frame: only during the fluid challenge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2014.