- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06512129
Defining Volume Status in Sepsis With Extracellular Water Measurement
Phenotypes in Sepsis - Extracellular Water for Volume Status Characterization
The goal of this observational study is to learn about the influence of extracellular water on volume status in adult sepsis patients presenting with hemodynamic instability. The main question it aims to answer is:
• Can measurement of extracellular water (MoistureMeterD, Delfin Technologies Ltd, Kuopio, Finland) contribute to the description of hemodynamic instability in adult sepsis patients.
Patients with sepsis admitted to intensive care will receive standard care with the addition of measurement of extracellular water.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Annelie Barrueta Tenhunen, MD, PhD
- Phone Number: +46728881882
- Email: annelie.barrueta@uu.se
Study Locations
-
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Uppsa
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Uppsala, Uppsa, Sweden, 75309
- Recruiting
- AnOpIva
-
Contact:
- Annelie B Tenhunen
- Phone Number: +4618660000
- Email: annelie.barrueta@uu.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults with sepsis.
Exclusion Criteria:
- Pregnancy, other than sepsis known cause of shock.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phenotypes in sepsis - extracellular water for volume status characterization.
Time Frame: 7 days
|
Can measurement of extracellular water (MoistureMeterD, Delfin Technologies Ltd, Kuopio, Finland) contribute to the description of hemodynamic instability in adult sepsis patients during the first 72 hours?
|
7 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Annelie Barrueta Tenhunen, MD, PhD, Uppsala University, Region Uppsala
Publications and helpful links
General Publications
- Nuutinen J, Ikaheimo R, Lahtinen T. Validation of a new dielectric device to assess changes of tissue water in skin and subcutaneous fat. Physiol Meas. 2004 Apr;25(2):447-54. doi: 10.1088/0967-3334/25/2/004.
- Toro C, Markarian B, Mayrovitz HN. Breast Cancer-Related Lymphedema Assessed via Tissue Dielectric Constant Measurements. Cureus. 2024 Apr 29;16(4):e59261. doi: 10.7759/cureus.59261. eCollection 2024 Apr.
- De Backer D, Cecconi M, Chew MS, Hajjar L, Monnet X, Ospina-Tascon GA, Ostermann M, Pinsky MR, Vincent JL. A plea for personalization of the hemodynamic management of septic shock. Crit Care. 2022 Dec 1;26(1):372. doi: 10.1186/s13054-022-04255-y.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-06866-01.1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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