Observational Study of Oxygen Delivery During a Fractional Fluid Expansion

NCT01826253 | Completed

• 1 other identifier: A12-D37-VOL.13
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypovolemia; Impaired Oxygen Delivery; Cardiac Output, Low

Keywords

Hypovolemia; Fluid challenge; Fluid expansion; Oxygene delivery; Cardiac output

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Study of central venous saturation

  only during the fluid challenge

Other Outcomes (1)

• study of cerebral and muscular oxygenation measured with near-infrared spectroscopy

  only during the fluid challenge

Study Arms (1)

Hypovolemia

Fluid expansion

Drug: hydroxyethylstarch 130/0.4

Interventions

hydroxyethylstarch 130/0.4 DRUG

Bolus of 100ml of HES 130/0.4 repeated until maximization of cardiac output

Hypovolemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

University Hospital of Caen

Caen, 14000, France

Location

MeSH Terms

Conditions

Hypovolemia; Cardiac Output, Low

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medecine Doctor

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: April 8, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 16, 2014

Record last verified: 2013-05

Locations

FR (1)