Volume Deficit Prior to Surgery

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00380107
First received: September 22, 2006
Last updated: August 5, 2009
Last verified: August 2009
  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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Rigshospitalet, Denmark

Additional 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
Study First Received: September 22, 2006
Last Updated: August 5, 2009
Health Authority: Denmark: National Board of Health

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

Additional relevant MeSH terms:
Hypovolemia
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014