Long-term OutcomeNCT04449796
Predictive Value of Bio-impedance Vector Analysis on Long-term Outcome in ICU Patients
An observational study of Long-term Outcome and Survival, run by Frisius Medisch Centrum at 1 site in Netherlands.
Trial summary
Phase angle, derived from bioimpedance analysis (BIA), reflects tissue quality and quantity in which cell mass, membrane integrity and hydration state are represented. Phase angle, as a measure of body composition, changes with the physical condition of patients and is associated with survival in several disease… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long-term Outcome, Survival
- How many people
- 1,025 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2018to 1 Jun 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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: all patiens admitted to the ICU
Who may be able to join
- all patients admitted to the ICU, elective and acute.
Who cannot join
- age below 18
- Length of stay at ICU < 6 hours
- All invalid bio-impedence analysis (BIA) measurements
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Medical Centre Leeuwarden - Intensive Care Unit
Leeuwarden, 8901 BR
About this study
Phase angle, derived from bioimpedance analysis (BIA), reflects tissue quality and quantity in which cell mass, membrane integrity and hydration state are represented. Phase angle, as a measure of body composition, changes with the physical condition of patients and is associated with survival in several disease states and during ICU admission. Aim of the study is to explore the predictive value of the phase angle for long term ICU outcome.
Read the detailed description
Phase angle, derived from bioimpedance analysis (BIA), reflects tissue quality and quantity in which cell mass, membrane integrity and hydration state are represented. Phase angle, as a measure of body composition, changes with the physical condition of patients and is associated with survival in several disease states and during ICU admission. Aim of the study is to explore the predictive value of the phase angle for long term ICU survival.
A single-centre prospective observational cohort will be performed with consecutive patients, elective and non elective, admitted to the ICU between 1st June 2018 and 1st June 2019. Demographic data, APACHE III, comorbidity and phase angle are collected and the ICU- , hospital- and 6 months survival will be registered.
- Conditions
- Long-term Outcome, Survival
What is being measured
The primary outcome is the main question the study is designed to answer.
3 months survival
100% minus all-cause mortality at three month post ICU
Measured: 3 months
6 months survival
100% minus all-cause mortality at six month post ICU
Measured: 6 months
12 months survival
100% minus all-cause mortalityat twelve month post ICU
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start1 Jun 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long-term OutcomeStudies of the same condition, open and under way.
- 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
- 1,025 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- E.C. Boerma, MD PhD, Principal investigator, Frisius Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449796
- Sponsor's protocol ID
- nWMO 2018-312
- Status last verified
- Jun 2020
- First submitted
- 24 Jun 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stellingwerf F, Beumeler LFE, Rijnhart-de Jong H, Boerma EC, Buter H. The predictive value of phase angle on long-term outcome after ICU admission. Clin Nutr. 2022 Jun;41(6):1256-1259. doi: 10.1016/j.clnu.2022.03.029. Epub 2022 Apr 6.
PubMed 35504168
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Bio-impedance Vector Analysis on Long-term Outcome in ICU Patients
- ClinicalTrials.gov ID
- NCT04449796
- Acronym / sponsor ID
- nWMO 2018-312
- Conditions
- Long-term Outcome, Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,025 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 29 Jun 2020 (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.
Phase angle, derived from bioimpedance analysis (BIA), reflects tissue quality and quantity in which cell mass, membrane integrity and hydration state are represented. Phase angle, as a measure of body composition, changes with the physical condition of patients and is associated with survival in several disease states and during ICU admission. Aim of the study is to explore the predictive value of the phase angle for long term ICU outcome.
Detailed description
Phase angle, derived from bioimpedance analysis (BIA), reflects tissue quality and quantity in which cell mass, membrane integrity and hydration state are represented. Phase angle, as a measure of body composition, changes with the physical condition of patients and is associated with survival in several disease states and during ICU admission. Aim of the study is to explore the predictive value of the phase angle for long term ICU survival.
A single-centre prospective observational cohort will be performed with consecutive patients, elective and non elective, admitted to the ICU between 1st June 2018 and 1st June 2019. Demographic data, APACHE III, comorbidity and phase angle are collected and the ICU- , hospital- and 6 months survival will be registered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patiens admitted to the ICU
Key inclusion criteria (1 listed)
- all patients admitted to the ICU, elective and acute.
Key exclusion criteria (3 listed)
- age below 18
- Length of stay at ICU < 6 hours
- All invalid bio-impedence analysis (BIA) measurements
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
3 months survival
Time frame: 3 months
100% minus all-cause mortality at three month post ICU
6 months survival
Time frame: 6 months
100% minus all-cause mortality at six month post ICU
12 months survival
Time frame: 12 months
100% minus all-cause mortalityat twelve month post ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Derived from this study: PubMed 35504168Stellingwerf F, Beumeler LFE, Rijnhart-de Jong H, Boerma EC, Buter H. The predictive value of phase angle on long-term outcome after ICU admission. Clin Nutr. 2022 Jun;41(6):1256-1259. doi: 10.1016/j.clnu.2022.03.029. Epub 2022 Apr 6.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
E.C. Boerma, MD PhD principal investigator
Frisius Medisch Centrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long-term Outcome and Survival, run by Frisius Medisch Centrum at 1 site in Netherlands.
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 3 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: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 months survival (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT04449796, which also lists 1 linked publication.
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 9 Jul 2020.