Fluid Balance and Body Weight Changes in Critically Ill Adult Patients

NCT ID: NCT04434079

Last Updated: 2020-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2018-12-01

Brief Summary

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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

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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

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Critical Illness Fluid Overload

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Regular critical care

Intervention Type OTHER

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.

Interventions

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Regular critical care

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ana Carolina P Antonio, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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2018-0486

Identifier Type: -

Identifier Source: org_study_id

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