NCT06590688

Brief Summary

The goal of this observational study is to learn about the influence of extracellular water on volume status in adult patients with intracranial hemorrhage presenting with hemodynamic instability. The main question it aims to answer is: • Can measurement of extracellular water contribute to the description of hemodynamic instability in adult patients with intracranial hemorrhage. Patients with intracranial hemorrhage admitted to intensive care will receive standard care with the addition of measurement of extracellular water.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
7mo left

Started Sep 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Sep 2024Dec 2026

First Submitted

Initial submission to the registry

July 18, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

September 23, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.9 years

First QC Date

July 18, 2024

Last Update Submit

September 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Extracellular water for volume status characterization in patients with intracranial hemorrhage.

    Can measurement of extracellular water (MoistureMeterD, Delfin Technologies Ltd, Kuopio, Finland) contribute to the description of hemodynamic instability in adult patients with intracranial hemorrhage during the first five days?

    7 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients admitted to ICU in Uppsala with intracranial hemorrhage.

You may qualify if:

  • Adults with intracranial hemorrhage admitted to ICU.

You may not qualify if:

  • Pregnancy, palliative care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 15132310BACKGROUND
  • 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: 38813316BACKGROUND
  • Gress DR; Participants in the International Multi-Disciplinary Consensus Conference on the Critical Care Management of Subarachnoid Hemorrhage. Monitoring of volume status after subarachnoid hemorrhage. Neurocrit Care. 2011 Sep;15(2):270-4. doi: 10.1007/s12028-011-9604-x.

    PMID: 21751101BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples.

MeSH Terms

Conditions

Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Annelie Barrueta Tenhunen

    Uppsala University, Region Uppsala

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annelie Barrueta Tenhunen

CONTACT

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 18, 2024

First Posted

September 19, 2024

Study Start

September 23, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

The data will only be accessible to the research team.