Defining Volume Status in Sepsis With Extracellular Water Measurement

NCT06512129 | Recruiting

• 1 other identifier: 2023-06866-01.1
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Phenotypes in sepsis - extracellular water for volume status characterization.

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to an ICU in Uppsala with suspected or confirmed sepsis.

You may qualify if:

• Adults with sepsis.

You may not qualify if:

• Pregnancy, other than sepsis known cause of shock.

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

AnOpIva

Uppsala, Uppsa, 75309, Sweden

RECRUITING

Related Publications (3)

• 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.

  PMID: 15132310 BACKGROUND

• 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.

  PMID: 38813316 BACKGROUND

• 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.

  PMID: 36457089 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Annelie Barrueta Tenhunen, MD, PhD

  Uppsala University, Region Uppsala

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annelie Barrueta Tenhunen, MD, PhD

CONTACT

+46728881882; annelie.barrueta@uu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 22, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)