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Observational Study of Oxygen Delivery During a Fractional Fluid Expansion (OR)

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ClinicalTrials.gov Identifier: NCT01826253
Recruitment Status : Completed
First Posted : April 8, 2013
Last Update Posted : June 16, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment
Hypovolemia Impaired Oxygen Delivery Cardiac Output, Low Drug: hydroxyethylstarch 130/0.4

Detailed Description:
One group of 20 anticipated patients

Study Design

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Study of Oxygen Delivery During a Fractional Fluid Expansion
Study Start Date : April 2013
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Hypovolemia
Fluid expansion
Drug: hydroxyethylstarch 130/0.4
Bolus of 100ml of HES 130/0.4 repeated until maximization of cardiac output


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Study of central venous saturation [ Time Frame: only during the fluid challenge ]
    Central venous gazes after each mini fluid challenge until cardiac output maximalization, from a central line


Other Outcome Measures:
  1. study of cerebral and muscular oxygenation measured with near-infrared spectroscopy [ Time Frame: only during the fluid challenge ]
    study of cerebral and muscular oxygenation measured with near-infrared spectroscopy after each mini fluid challenge until cardiac output maximalization, from a central line


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Mechanically ventilated patients after elective cardiac surgery with oesophageal Doppler for cardiac output monitoring and arterial and venous central line
Criteria

Inclusion Criteria:

  • Adults over 18 years
  • Patients in intensive care after cardiac surgery under mechanically ventilation and with oesophageal Doppler

Exclusion Criteria:

  • Arrythmia
  • Pregnancy or childrens
  • Patients without cardiac output monitoring with oesophageal Doppler
  • Patients without medical indication for fluid expansion
  • Urgency surgery
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826253


Locations
France
University Hospital of Caen
Caen, France, 14000
Sponsors and Collaborators
University Hospital, Caen
More Information

Responsible Party: Marc-Olivier FISCHER, Medecine Doctor, University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01826253     History of Changes
Other Study ID Numbers: A12-D37-VOL.13
First Posted: April 8, 2013    Key Record Dates
Last Update Posted: June 16, 2014
Last Verified: May 2013

Keywords provided by Marc-Olivier FISCHER, University Hospital, Caen:
Hypovolemia
Fluid challenge
Fluid expansion
Oxygene delivery
Cardiac output

Additional relevant MeSH terms:
Hypovolemia
Cardiac Output, Low
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes