Volume Deficit Prior to Surgery

NCT ID: NCT00380107

Last Updated: 2009-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypovolemia Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Planned minor or medium sized surgery

Exclusion Criteria

* Oesophageal pathology
* Age \>90 yr or \< 18 yr
* Alcohol abuse,
* Insulin dependent DM
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Section of surgical pathophysiology

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Morten Bundgaard-Nielsen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rigshospitalet, ABD centret, anaesthesiological dept. 2041

Copenhagen, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

Bundgaard-Nielsen M, Jorgensen CC, Kehlet H, Secher NH. Normovolemia defined according to cardiac stroke volume in healthy supine humans. Clin Physiol Funct Imaging. 2010 Sep;30(5):318-322. doi: 10.1111/j.1475-097X.2010.00944.x. Epub 2010 Jun 10.

Reference Type DERIVED
PMID: 20545713 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Opt. medium 1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fluid Infusion During Breast Surgery
NCT00431743 UNKNOWN PHASE4