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Not yet recruitingNCT06590688Updated Sep 19, 2024

Defining Volume Status with Extracellular Water Measurement in Patients with Intracranial Hemorrhage

An observational study in Intracranial Hemorrhages, sponsored by Uppsala University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Uppsala University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study 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.
Read the detailed description

Adult patients with intracranial hemorrhage admitted to ICU will be recruited. During the first five days after inclusion blood samples and extended non-invasive monitoring, including monitoring of the microcirculation (CytoCam) and measurement of extracellular water (dielectronic constant), will be added to routine care and monitoring.

02

Conditions studied

  • Intracranial Hemorrhages
03

In context

Intracranial Hemorrhages

204 studies on the registry are indexed under Intracranial Hemorrhages; 66 are open to participants now.

This study's planned enrollment of 10 is below the median of 236 across 89 observational studies indexed under Intracranial Hemorrhages.

Browse Intracranial Hemorrhages studies →

Lead sponsor

Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients admitted to ICU in Uppsala with intracranial hemorrhage.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults with intracranial hemorrhage admitted to ICU.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy, palliative care.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Target follow-up
7 Days
Patient registry
Yes
Biospecimen retention
Samples with dna
06

What researchers measure

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?

    Time frame: 7 days

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 15132310 ↗
  • 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. PubMed 38813316 ↗
  • 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. PubMed 21751101 ↗

Individual participant data

Plan to share: No — The data will only be accessible to the research team.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2024; primary completion for Sep 2026, 24 months later.

Of 43 observational studies under Intracranial Hemorrhages, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 103. This study's planned 24 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 18, 2024
First posted
Sep 19, 2024
StartEst.
Sep 23, 2024
Primary completionEst.
Sep 2026
CompletionEst.
Dec 2026
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06590688
Lead sponsor
Uppsala University
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Sep 23, 2024 (estimated)
Primary completion
Sep 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 19, 2024

Study contacts

Annelie Barrueta Tenhunen
Contact
annelie.barrueta@uu.se
0186110000
Annelie Barrueta Tenhunen
principal investigator · Uppsala University, Region Uppsala

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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