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

This study is currently recruiting participants.
Verified May 2013 by University Hospital, Caen
Sponsor:
Information provided by (Responsible Party):
Marc-Olivier FISCHER, University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01826253
First received: March 20, 2013
Last updated: July 30, 2013
Last verified: May 2013
  Purpose

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 Intervention
Hypovolemia
Impaired Oxygen Delivery
Cardiac Output, Low
Drug: hydroxyethylstarch 130/0.4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Study of Oxygen Delivery During a Fractional Fluid Expansion

Resource links provided by NLM:


Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • Measurement of oxygen delivery [ Time Frame: only during the fluid challenge ] [ Designated as safety issue: Yes ]
    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:
  • Study of central venous saturation [ Time Frame: only during the fluid challenge ] [ Designated as safety issue: Yes ]
    Central venous gazes after each mini fluid challenge until cardiac output maximalization, from a central line


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


Estimated Enrollment: 20
Study Start Date: April 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hypovolemia
Fluid expansion
Drug: hydroxyethylstarch 130/0.4
Bolus of 100ml of HES 130/0.4 repeated until maximization of cardiac output

Detailed Description:

One group of 20 anticipated patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01826253

Locations
France
University Hospital of Caen Recruiting
Caen, France, 14000
Contact: Marc-Olivier FISCHER, M.D.       fischer-mo@chu-caen.fr   
Sponsors and Collaborators
University Hospital, Caen
  More Information

No publications provided

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
Study First Received: March 20, 2013
Last Updated: July 30, 2013
Health Authority: France: Committee for the Protection of Personnes

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

Additional relevant MeSH terms:
Cardiac Output, Low
Hypovolemia
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms
Pathologic Processes
Hetastarch
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014