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NCT Number: NCT04434079

Fluid Balance and Body Weight Changes in Critically Ill Adult Patients

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.

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Key information

Conditions

Critical Illness Body Weight Body Weight Changes Disease Attributes Edema Fluid Overload Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Regular critical care

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 16, 2020
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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