Volume Deficit Prior to Surgery

August 5, 2009 updated by: Rigshospitalet, Denmark

Estimation of Volume Deficit in Patients Prior to Surgery

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

4

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

  • Denmark
      • Copenhagen, Denmark, DK-2100
        • Rigshospitalet, ABD centret, anaesthesiological dept. 2041

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients for surgery in 3 procedures:

  • mastectomy
  • rad. prostatectomy
  • open adb. surgery

And 20 healthy subjects

Description

Inclusion Criteria:

  • Planned minor or medium sized surgery

Exclusion Criteria:

  • Oesophageal pathology
  • Age >90 yr or < 18 yr
  • Alcohol abuse,
  • Insulin dependent DM

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

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Morten Bundgaard-Nielsen, M.D., Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 22, 2006

First Submitted That Met QC Criteria

September 22, 2006

First Posted (Estimate)

September 25, 2006

Study Record Updates

Last Update Posted (Estimate)

August 6, 2009

Last Update Submitted That Met QC Criteria

August 5, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Opt. medium 1

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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