Observational Study of Oxygen Delivery During a Fractional Fluid Expansion

Hypovolemia Clinical Trial

— OR  

Official title:

Observational Study of Oxygen Delivery During a Fractional Fluid Expansion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826253
• Other study ID #: A12-D37-VOL.13
• Status: Completed
• Phase: N/A
• First received: March 20, 2013
• Last updated: June 13, 2014
• Start date: April 2013
• Est. completion date: June 2014

Study information

• Verified date: May 2013
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Observational

Clinical 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. 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.

Description:

One group of 20 anticipated patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiac Output, Low
• Hypovolemia
• Impaired Oxygen Delivery

Intervention

Drug:
• hydroxyethylstarch 130/0.4
Bolus of 100ml of HES 130/0.4 repeated until maximization of cardiac output

Locations

Country	Name	City	State
France	University Hospital of Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	study of cerebral and muscular oxygenation measured with near-infrared spectroscopy	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	Yes
Primary	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.	only during the fluid challenge	Yes
Secondary	Study of central venous saturation	Central venous gazes after each mini fluid challenge until cardiac output maximalization, from a central line	only during the fluid challenge	Yes