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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00380107
Other study ID # Opt. medium 1
Secondary ID
Status Completed
Phase Phase 4
First received September 22, 2006
Last updated August 5, 2009
Start date October 2006
Est. completion date August 2007

Study information

Verified date August 2009
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Observational

Clinical Trial Summary

It is the purpose of the researchers to identify the variation in intravascular deficits which can have relevance in high risk patients for minor and medium sized surgery.

The investigators will also estimate fluid deficit in healthy, non-fasting subjects for comparison.


Description:

Intravascular volume optimization has shown to improve outcome after surgery. In minor and medium surgery , however, the preoperative volume deficit has not been estimated with functional parameters. Patient scheduled for minor surgery are included. After the patient is anesthetized the intravascular volume is optimized by stroke volume maximization by colloid boluses. Stroke volume is obtained by esophageal Doppler technique which is a minimally invasive method.

The volume estimated for optimization is considered as the functional volume deficit.

In the healthy subjects the probe will be placed in the awake subject. A standardized meal and fluid intake secures that the subjects are in a non-fasting state.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Planned minor or medium sized surgery

Exclusion Criteria:

- Oesophageal pathology

- Age >90 yr or < 18 yr

- Alcohol abuse,

- Insulin dependent DM

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Rigshospitalet, ABD centret, anaesthesiological dept. 2041 Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

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