- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04434079
Fluid Balance and Body Weight Changes in Critically Ill Adult Patients
June 12, 2020 updated by: Hospital de Clinicas de Porto Alegre
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
98
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil
- Hospital de Clinicas de Porto Alegre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- Individuals aged >18 years-old admitted to ICU;
- Expected length of ICU stay superior to 24 hours.
Exclusion Criteria:
- Individuals receiving oral diet;
- Actual body weight superior to 227kgs or 501lb.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
At midnight every 24 hours up to patient's ICU discharge or up to 6 months, whichever comes first.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between cumulative fluid balance and total weight change
Time Frame: Last day of each patient's ICU hospitalization, up to 6 months
|
Correlation between cumulative fluid balance and total weight change (Bland-Altman)
|
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
|
Area under ROC curve for fluid balance (L).
ICU mortality as reference variable.
|
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
|
Area under ROC curve for body weight change (kg).
ICU mortality as reference variable.
|
Through study completion, up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ana Carolina P Antonio, MD, PhD, Hospital de Clinicas de Porto Alegre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2018
Primary Completion (Actual)
October 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
June 5, 2020
First Submitted That Met QC Criteria
June 12, 2020
First Posted (Actual)
June 16, 2020
Study Record Updates
Last Update Posted (Actual)
June 16, 2020
Last Update Submitted That Met QC Criteria
June 12, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-0486
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Critical Illness
-
Duke UniversityNational Institute of Neurological Disorders and Stroke (NINDS); National Institutes...CompletedNeonatal Critical Illness | Pediatric Critical IllnessUnited States
-
Yale UniversityNational Institute on Aging (NIA)RecruitingCritical Illness | Illness, CriticalUnited States
-
McMaster UniversityLondon Health Sciences Centre; McMaster Children's Hospital; Canadian Critical...CompletedPediatric Critical IllnessCanada
-
Boston Children's HospitalCompleted
-
St Helens & Knowsley Teaching Hospitals NHS TrustManchester University NHS Foundation TrustCompleted
-
Sándor BeniczkyUniversity of Aarhus; Danish Council for Independent Research; Søster og Verner...CompletedCritical Illness Myopathy | Myopathy Critical IllnessDenmark
-
Hospital de Clinicas de Porto AlegreUnknownCritical Illness PolyneuropathiesBrazil
-
Peking Union Medical College HospitalBaxter Healthcare CorporationUnknownNutrition Therapy for Critical Illness
-
University Hospital Birmingham NHS Foundation TrustCompletedRehabilitation After Critical Illness
-
Assistance Publique - Hôpitaux de ParisRecruitingCritical Illness Related Corticosteroids InsufficiencyFrance
Clinical Trials on Regular critical care
-
National Taiwan University HospitalRecruiting
-
National Taiwan University HospitalRecruiting
-
Beth Israel Medical CenterCompletedShock | Respiratory FailureUnited States
-
Hospital Israelita Albert EinsteinActive, not recruitingCritical Care | Intensive Care UnitBrazil
-
Baqiyatallah Medical Sciences UniversityNot yet recruitingMorality | Treatment Compliance
-
Ictal GroupVersailles HospitalCompleted
-
Saint Savvas Anticancer HospitalSuspendedPain | Intensive Care UnitsGreece
-
University of PittsburghMassachusetts General Hospital; National Institute on Aging (NIA)RecruitingCritical IllnessUnited States
-
Istanbul Bilgi UniversityIstanbul University - Cerrahpasa (IUC)Enrolling by invitationPressure Injury | Incontinence-associated DermatitisTurkey