Intracranial HemorrhagesNCT06590688
Defining Volume Status with Extracellular Water Measurement in Patients with Intracranial Hemorrhage
An observational study of Intracranial Hemorrhages, run by Uppsala University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hemorrhages
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 23 Sep 2024to Dec 2026
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to ICU in Uppsala with intracranial hemorrhage.
Who may be able to join
- Adults with intracranial hemorrhage admitted to ICU.
Who cannot join
- Pregnancy, palliative care.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Extracellular Water for Volume Status Characterization in Patients with Intracranial Hemorrhage
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.
- Conditions
- Intracranial Hemorrhages
- Medical subject headings
- Intracranial Hemorrhages
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start23 Sep 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intracranial HemorrhagesStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annelie Barrueta Tenhunen, Principal investigator, Uppsala University, Region Uppsala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590688
- Sponsor's protocol ID
- 2023-06866-01.3
- Other IDs
- 2023
- Status last verified
- Sep 2024
- First submitted
- 18 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will only be accessible to the research team.
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 15132310Toro 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 38813316Gress 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracellular Water for Volume Status Characterization in Patients with Intracranial Hemorrhage
- ClinicalTrials.gov ID
- NCT06590688
- Acronym / sponsor ID
- 2023-06866-01.3
- Conditions
- Intracranial Hemorrhages
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 23 Sep 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to ICU in Uppsala with intracranial hemorrhage.
Key inclusion criteria (1 listed)
- Adults with intracranial hemorrhage admitted to ICU.
Key exclusion criteria (1 listed)
- Pregnancy, palliative care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Extracellular water for volume status characterization in patients with intracranial hemorrhage.
Time frame: 7 days
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?
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 15132310Nuutinen 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.
- Background: PubMed 38813316Toro 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.
- Background: PubMed 21751101Gress 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.
- Individual participant dataSharing planned: No. The data will only be accessible to the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annelie Barrueta Tenhunen principal investigator
Uppsala University, Region Uppsala
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Hemorrhages, run by Uppsala University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annelie Barrueta Tenhunen (0186110000, annelie.barrueta@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extracellular water for volume status characterization in patients with intracranial hemorrhage. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06590688, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.