HypovolemiaNCT00380107
Volume Deficit Prior to Surgery
An observational study of Hypovolemia and Surgery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypovolemia, Surgery
- How many people
- 4 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2006to Aug 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients for surgery in 3 procedures: * mastectomy * rad. prostatectomy * open adb. surgery And 20 healthy subjects
Who may be able to join
- Planned minor or medium sized surgery
Who cannot join
- Oesophageal pathology
- Age >90 yr or < 18 yr
- Alcohol abuse,
- Insulin dependent DM
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet, ABD centret, anaesthesiological dept. 2041
Copenhagen, DK-2100
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypovolemia, Surgery
- Keywords
- Minor surgery, Volume optimization, Volume deficit, Epidural anesthesia
- Medical subject headings
- Hypovolemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypovolemiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Morten Bundgaard-Nielsen, M.D., Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380107
- Sponsor's protocol ID
- Opt. medium 1
- Status last verified
- Aug 2009
- First submitted
- 22 Sep 2006
- Last updated
- 6 Aug 2009
- Results posted
- No
Publications
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.
PubMed 20545713
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Volume Deficit in Patients Prior to Surgery
- ClinicalTrials.gov ID
- NCT00380107
- Acronym / sponsor ID
- Opt. medium 1
- Conditions
- Hypovolemia, Surgery
- Keywords
- Minor surgery, Volume optimization, Volume deficit, Epidural anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 25 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients for surgery in 3 procedures: * mastectomy * rad. prostatectomy * open adb. surgery And 20 healthy subjects
Key inclusion criteria (1 listed)
- Planned minor or medium sized surgery
Key exclusion criteria (4 listed)
- Oesophageal pathology
- Age >90 yr or < 18 yr
- Alcohol abuse,
- Insulin dependent DM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
- Derived from this study: PubMed 20545713Bundgaard-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten Bundgaard-Nielsen, M.D. principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypovolemia and Surgery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00380107, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2009.