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

June 13, 2014 updated by: Marc-Olivier FISCHER, University Hospital, Caen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One group of 20 anticipated patients

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • University Hospital of Caen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
only during the fluid challenge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
only during the fluid challenge

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
only during the fluid challenge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

April 3, 2013

First Posted (Estimate)

April 8, 2013

Study Record Updates

Last Update Posted (Estimate)

June 16, 2014

Last Update Submitted That Met QC Criteria

June 13, 2014

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A12-D37-VOL.13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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