## Protocol Section
### Identification Module
**NCT ID:** NCT04434079

**Brief Title:** Fluid Balance and Body Weight Changes in Critically Ill Adult Patients

**Official Title:** Fluid Balance and Body Weight Changes in Critically Ill Adult Patients

#### Organization Study ID Info
**ID:** 2018-0486
#### Organization
**Class:** OTHER
**Full Name:** Hospital de Clinicas de Porto Alegre
### Status Module
#### Completion Date
**Date:** 2018-12-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-06-16

**Type:** ACTUAL

**Last Update Submit Date:** 2020-06-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-10-01

**Type:** ACTUAL

#### Start Date
**Date:** 2018-06-01

**Type:** ACTUAL

**Status Verified Date:** 2020-06

#### Study First Post Date
**Date:** 2020-06-16
**Type:** ACTUAL
**Study First Submit Date:** 2020-06-05
**Study First Submit QC Date:** 2020-06-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospital de Clinicas de Porto Alegre

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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. 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.

### Conditions Module

**Conditions:**

- Critical Illness

- Fluid Overload

**Keywords:**

- Fluid Balance

- Body Weight Change

- Critical Illness

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 98

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: Regular critical care

**Label:** Included individuals

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Included individuals

**Description:** 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.

**Name:** Regular critical care

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Correlation between daily fluid balance and weight change (Bland-Altman agreement test)

**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.

#### Secondary Outcomes

**Description:** Correlation between cumulative fluid balance and total weight change (Bland-Altman)

**Measure:** Correlation between cumulative fluid balance and total weight change

**Time Frame:** Last day of each patient's ICU hospitalization, up to 6 months

**Description:** Area under ROC curve for fluid balance (L). ICU mortality as reference variable.

**Measure:** Discriminative power of fluid balance in predicting ICU mortality

**Time Frame:** Through study completion, up to 6 months

**Description:** Area under ROC curve for body weight change (kg). ICU mortality as reference variable.

**Measure:** Discriminative power of body weight changes in predicting ICU mortality

**Time Frame:** Through study completion, up to 6 months

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Porto Alegre

**Country:** Brazil

**Facility:** Hospital de Clínicas de Porto Alegre

**State:** RS

#### Overall Officials

**Official 1:**

**Affiliation:** Hospital de Clínicas de Porto Alegre

**Name:** Ana Carolina P Antonio, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5114

- Name: Body Weight

- Relevance: HIGH

- As Found: Body Weight

- ID: M5115

- Name: Body Weight Changes

- Relevance: HIGH

- As Found: Body Weight Changes

- ID: M19010

- Name: Critical Illness

- Relevance: HIGH

- As Found: Critical Illness

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016638

- Term: Critical Illness

- ID: D000001835

- Term: Body Weight

- ID: D000001836

- Term: Body Weight Changes

### Misc Info Module

- Version Holder: 2024-05-24
