HypovolemiaNCT00286338
Comparison of Monitors of Fluid Therapy
An observational study of Hypovolemia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The investigators want to correlate different methods to guide fluid therapy. The investigators know that guidance by esophagus doppler technique has improved outcome and want to correlate other already used techniques to esophagus doppler. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Hypovolemia
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2006to Apr 2006
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Elective urological surgery in which a central venous catheter is routinely administered
- Informed consent
Who cannot join
- Age 70 years or older
- No informed consent
- Pathology in the esophagus that contraindicates use off gastric tube and esophagus doppler
- ASA III or above
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej
Copenhagen, DK-2100
About this study
The investigators want to correlate different methods to guide fluid therapy. The investigators know that guidance by esophagus doppler technique has improved outcome and want to correlate other already used techniques to esophagus doppler.
Read the detailed description
Fluid therapy before and under surgery can be guided by measurement of the hearts ability to eject blood (cardiac output). By doing this it has been shown that the occurrence of nausea,vomiting and complications generally can be reduced. The function of the heart has been measured with a probe in the esophagus in in earlier studies. We want to correlate these results with other techniques by which fluid therapy also is guided in daily practice. These are: SVO2, modelflow (finapres)and NIRS.
These methods are noninvasive except SVO2 measurement which requires a central venous catheter (CVK). Therefore we have chosen a population in which CVK is standard in our institution. We thereby don´t apply any further risks than daily practice and the project is considered as a quality assessment of used standards.
- Conditions
- Hypovolemia
- Keywords
- Fluid therapy, Monitoring
- 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 posted3 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 12 participants
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Henrik Kehlet, M.D., Ph.D, Study director, dept of surgical patophysiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286338
- Sponsor's protocol ID
- des.prost-1
- Status last verified
- Jan 2009
- First submitted
- 1 Feb 2006
- Last updated
- 14 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Monitors of Fluid Therapy
- ClinicalTrials.gov ID
- NCT00286338
- Acronym / sponsor ID
- des.prost-1
- Conditions
- Hypovolemia
- Keywords
- Fluid therapy, Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Apr 2006 (actual)
- First posted
- 3 Feb 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.
The investigators want to correlate different methods to guide fluid therapy. The investigators know that guidance by esophagus doppler technique has improved outcome and want to correlate other already used techniques to esophagus doppler.
Detailed description
Fluid therapy before and under surgery can be guided by measurement of the hearts ability to eject blood (cardiac output). By doing this it has been shown that the occurrence of nausea,vomiting and complications generally can be reduced. The function of the heart has been measured with a probe in the esophagus in in earlier studies. We want to correlate these results with other techniques by which fluid therapy also is guided in daily practice. These are: SVO2, modelflow (finapres)and NIRS.
These methods are noninvasive except SVO2 measurement which requires a central venous catheter (CVK). Therefore we have chosen a population in which CVK is standard in our institution. We thereby don´t apply any further risks than daily practice and the project is considered as a quality assessment of used standards.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Elective urological surgery in which a central venous catheter is routinely administered
- Informed consent
Key exclusion criteria (4 listed)
- Age 70 years or older
- No informed consent
- Pathology in the esophagus that contraindicates use off gastric tube and esophagus doppler
- ASA III or above
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 14 Jan 2009.
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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.
Henrik Kehlet, M.D., Ph.D study director
dept of surgical patophysiology
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, 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 3 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 14 Jan 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?
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 14 Jan 2009; AzTrials last refreshed its copy on 7 Nov 2026.