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Volume Deficit Prior to Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00380107
First Posted: September 25, 2006
Last Update Posted: August 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rigshospitalet, Denmark
  Purpose

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.


Condition Phase
Hypovolemia Surgery Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Estimation of Volume Deficit in Patients Prior to Surgery

Further study details as provided by Rigshospitalet, Denmark:

Enrollment: 4
Study Start Date: October 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients for surgery in 3 procedures:

  • mastectomy
  • rad. prostatectomy
  • open adb. surgery

And 20 healthy subjects

Criteria

Inclusion Criteria:

  • Planned minor or medium sized surgery

Exclusion Criteria:

  • Oesophageal pathology
  • Age >90 yr or < 18 yr
  • Alcohol abuse,
  • Insulin dependent DM
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00380107


Locations
Denmark
Rigshospitalet, ABD centret, anaesthesiological dept. 2041
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Morten Bundgaard-Nielsen, M.D. Rigshospitalet, Denmark
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Henrik Kehlet, Section of surgical pathophysiology
ClinicalTrials.gov Identifier: NCT00380107     History of Changes
Other Study ID Numbers: Opt. medium 1
First Submitted: September 22, 2006
First Posted: September 25, 2006
Last Update Posted: August 6, 2009
Last Verified: August 2009

Keywords provided by Rigshospitalet, Denmark:
Minor surgery
Volume optimization
Volume deficit
Epidural anesthesia

Additional relevant MeSH terms:
Hypovolemia
Pathologic Processes