Critical IllnessNCT04434079
Fluid Balance and Body Weight Changes in Critically Ill Adult Patients
An observational study of Critical Illness and Fluid Overload, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Positive fluid status has been consistently associated with worse prognosis in critically ill adult patients.However, observational studies showed poor agreement between fluid balance and body weight changes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Fluid Overload
- What is being tested?
- Regular critical care
- Type of treatment
- Pill or oral medicine
- How many people
- 98 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2018to 1 Dec 2018
- 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 adult patients consecutively admitted to the ICU from June to October 2018 are eligible if expected length of ICU stay is superior to 24 hours and no oral nutritional is being offered.
Who may be able to join
- Individuals aged >18 years-old admitted to ICU;
- Expected length of ICU stay superior to 24 hours.
Who cannot join
- Individuals receiving oral diet;
- Actual body weight superior to 227kgs or 501lb.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
Positive fluid status has been consistently associated with worse prognosis in critically ill adult patients.However, observational studies showed poor agreement between fluid balance and body weight changes. The objective of the study is to compare the measurements of FB and BW over time and to assess correlation with ICU mortality.
Read the detailed description
Positive fluid status has been consistently associated with worse prognosis in critically ill adult patients. Daily and cumulative fluid balance (FB) is a routine nursing activity in intensive care unit (ICU). In view of the potential for errors in the calculation of FB totals and the problem of accounting for insensible fluid losses, measurement of body weight (BW) changes is an alternative non-invasive method commonly used for estimating body fluid status. Its accuracy over FB assumes a one kilogram change in BW equates to a one liter gain or loss in body fluid volume. However, observational studies showed poor agreement between those measurements, particularly among individuals staying more than a week in ICU possibly due to muscle and fat loss as well as bone demineralization. The objective of the study is to compare the measurements of FB and BW over time and to assess correlation with ICU mortality.
- Conditions
- Critical Illness, Fluid Overload
- Being tested
- Regular critical care
- Keywords
- Fluid Balance, Body Weight Change, Critical Illness
- Medical subject headings
- Critical Illness, Edema, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular critical careOther
Clinical demographic data, daily and cumulative FB (input minus output) with and without insensible fluid losses, and daily and total BW changes are recorded, as well as survival outcome.
| Study group | Role | What they receive |
|---|---|---|
| Included individuals | Adult patients consecutively admitted to the ICU from June to October 2018 are eligible if expected length of stay is superior to 24 hours and no oral nutritional has been offered. Receives: Other: Regular critical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between daily fluid balance (difference between fluid input and output during 24 hours) and the change on daily weight
Correlation between daily fluid balance and weight change (Bland-Altman agreement test)
Measured: At midnight every 24 hours up to patient's ICU discharge or up to 6 months, whichever comes first.
Secondary outcomes (3)
Correlation between cumulative fluid balance and total weight change
Correlation between cumulative fluid balance and total weight change (Bland-Altman)
Measured: Last day of each patient's ICU hospitalization, up to 6 months
Discriminative power of fluid balance in predicting ICU mortality
Area under ROC curve for fluid balance (L). ICU mortality as reference variable.
Measured: Through study completion, up to 6 months
Discriminative power of body weight changes in predicting ICU mortality
Area under ROC curve for body weight change (kg). ICU mortality as reference variable.
Measured: Through study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Jun 2018
- Primary completion1 Oct 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Carolina P Antonio, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434079
- Sponsor's protocol ID
- 2018-0486
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Balance and Body Weight Changes in Critically Ill Adult Patients
- ClinicalTrials.gov ID
- NCT04434079
- Acronym / sponsor ID
- 2018-0486
- Conditions
- Critical Illness, Fluid Overload
- Keywords
- Fluid Balance, Body Weight Change, Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 16 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.
Positive fluid status has been consistently associated with worse prognosis in critically ill adult patients.However, observational studies showed poor agreement between fluid balance and body weight changes. The objective of the study is to compare the measurements of FB and BW over time and to assess correlation with ICU mortality.
Detailed description
Positive fluid status has been consistently associated with worse prognosis in critically ill adult patients. Daily and cumulative fluid balance (FB) is a routine nursing activity in intensive care unit (ICU). In view of the potential for errors in the calculation of FB totals and the problem of accounting for insensible fluid losses, measurement of body weight (BW) changes is an alternative non-invasive method commonly used for estimating body fluid status. Its accuracy over FB assumes a one kilogram change in BW equates to a one liter gain or loss in body fluid volume. However, observational studies showed poor agreement between those measurements, particularly among individuals staying more than a week in ICU possibly due to muscle and fat loss as well as bone demineralization. The objective of the study is to compare the measurements of FB and BW over time and to assess correlation with ICU mortality.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Included individuals | – | Other: Regular critical careAdult patients consecutively admitted to the ICU from June to October 2018 are eligible if expected length of stay is superior to 24 hours and no oral nutritional has been offered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients consecutively admitted to the ICU from June to October 2018 are eligible if expected length of ICU stay is superior to 24 hours and no oral nutritional is being offered.
Key inclusion criteria (2 listed)
- Individuals aged >18 years-old admitted to ICU;
- Expected length of ICU stay superior to 24 hours.
Key exclusion criteria (2 listed)
- Individuals receiving oral diet;
- Actual body weight superior to 227kgs or 501lb.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular critical careClinical demographic data, daily and cumulative FB (input minus output) with and without insensible fluid losses, and daily and total BW changes are recorded, as well as survival outcome. | Other | Included individuals |
Primary outcome
Correlation between daily fluid balance (difference between fluid input and output during 24 hours) and the change on daily weight
Time frame: At midnight every 24 hours up to patient's ICU discharge or up to 6 months, whichever comes first.
Correlation between daily fluid balance and weight change (Bland-Altman agreement test)
3 secondary outcomes
Correlation between cumulative fluid balance and total weight change
Time frame: Last day of each patient's ICU hospitalization, up to 6 months
Discriminative power of fluid balance in predicting ICU mortality
Time frame: Through study completion, up to 6 months
Discriminative power of body weight changes in predicting ICU mortality
Time frame: Through study completion, up to 6 months
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 16 Jun 2020.
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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.
Ana Carolina P Antonio, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre
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 Critical Illness and Fluid Overload, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 2 inclusion and 2 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 16 Jun 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 Brazil. 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?
Correlation between daily fluid balance (difference between fluid input and output during 24 hours) and the change on daily weight (time frame: At midnight every 24 hours up to patient's ICU discharge or up to 6 months, whichever comes first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2020.