- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00599794
A Simple Clinical Tool to Help Assess Patient Volume (Fluid) Status
January 23, 2008 updated by: Mayo Clinic
Patients may have actual or relative intravascular volume depletion in a number of different disease states, particularly with sepsis syndrome.
However, it is clinically difficult to determine volume status without invasive monitoring, which may cause unintended complications.
Our hypothesis is that we can accurately estimate central venous pressure, which is a surrogate marker of volume status, with a noninvasive portable ultrasound device.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
84
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55407
- Abbott Northwestern Hospital
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy volunteers, then critically ill patients already in the intensive care unit who are felt to have intravascular volume depletion.
Description
Inclusion Criteria:
- Age 18 or older.
- Healthy, euvolemic volunteers and critically ill patients who are already in an intensive care unit and who will have a central venous catheter placed as part of their planned medical treatment.
Exclusion Criteria:
- Inability to use ultrasound to measure jugular vein (neck brace or bandage), "code" situation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Healty volunteers who are euvolemic.
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2
Critically ill patients who will be having a central venous catheter with a monitor to measure central venous pressure placed as part of their planned care independent of this study.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: A. S. Keller, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
January 11, 2008
First Submitted That Met QC Criteria
January 23, 2008
First Posted (Estimate)
January 24, 2008
Study Record Updates
Last Update Posted (Estimate)
January 24, 2008
Last Update Submitted That Met QC Criteria
January 23, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-004138
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of California, San FranciscoNational Cancer Institute (NCI)RecruitingSepsis | Sepsis, Severe | Sepsis and Septic Shock | Sepsis at Intensive Care Unit | Sepsis, Septic Shock | Sepsis, Severe Sepsis and Septic Shock | Sepsis With Multiple Organ Dysfunction (MOD) | Sepsis With Acute Organ DysfunctionUnited States
-
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University of Kansas Medical CenterUniversity of KansasRecruitingSepsis | Septic Shock | Sepsis Syndrome | Sepsis, Severe | Sepsis Bacterial | Sepsis BacteremiaUnited States
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Jip GroenInBiomeRecruitingMicrobial Colonization | Neonatal Infection | Neonatal Sepsis, Early-Onset | Microbial Disease | Clinical Sepsis | Culture Negative Neonatal Sepsis | Neonatal Sepsis, Late-Onset | Culture Positive Neonatal SepsisNetherlands
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The University of QueenslandRoyal Brisbane and Women's HospitalUnknown
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Karolinska InstitutetÖrebro University, SwedenCompletedSepsis | Sepsis Syndrome | Sepsis, SevereSweden
-
Ohio State UniversityCompletedSepsis, Severe Sepsis and Septic ShockUnited States
-
Indonesia UniversityCompletedSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockIndonesia
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University of LeicesterUniversity Hospitals, Leicester; The Royal College of AnaesthetistsCompletedSepsis | Septic Shock | Severe Sepsis | Sepsis SyndromeUnited Kingdom
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Beckman Coulter, Inc.Biomedical Advanced Research and Development AuthorityEnrolling by invitationSevere Sepsis | Severe Sepsis Without Septic ShockUnited States