Assessment of Hydration Status Using Bioelectrical Impedance Vector Analysis

October 14, 2016 updated by: Maria Cristina Gonzalez, Catholic University of Pelotas

Assessment of Hydration Status Using Bioelectrical Impedance Vector Analysis in Critical Patients With Acute Kidney Injury

The state of hyperhydration in critically ill patients with acute kidney injury (AKI) is associated with increased mortality. Bioelectrical impedance vector analysis (BIVA) appears to be a viable method to access the fluid status of critical patients but has never been evaluated in critical patients with AKI. The objective of this study is to evaluate the hydration status using BIVA in critical patients under intensive care at the time of AKI diagnosis and to correlate this measurement with mortality. A sample of 224 patients with AKI will be evaluated by BIVA and followed until they are discharged or death in intensive care unit and the BIVA vectors will be analysed to define differences in hydration characteristics from each group.

Study Overview

Status

Completed

Detailed Description

Patients admitted to Intensive Care Unit (ICU) will be assessed by BIVA at the moment of the AKI diagnosis. They will be followed up to 12 weeks, until hospital discharge or death. The association between survival and hydration status, as assessed by BIVA in the first AKI day, will be tested.

Study Type

Observational

Enrollment (Actual)

224

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

Non-Probability Sample

Study Population

Intensive care patients who developed acute kidney injury after ICU admission

Description

Inclusion Criteria:

  • Patients older than 18 years who developed acute kidney injury after admission in Intensive Care Unit

Exclusion Criteria:

  • Chronic kidney injury, dialysis-dependent chronic kidney injury, acute kidney injury before ICU admission, kidney transplant, morbidity obesity and limb amputation.

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

Cohorts and Interventions

Group / Cohort
critical patients with AKI
Critical patients with AKI will be followed up to 12 weeks after diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of survivors in patients with AKI diagnosis during ICU
Time Frame: Up to 12 weeks after AKI diagnosis
Patients admitted in ICU will be followed up to 2 weeks after AKI diagnosis and survival will be analyzed according to their hydration status assessed by BIVA.
Up to 12 weeks after AKI diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Maria Cristina Gonzalez, MD, PhD, Catholic University of Pelotas

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

May 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

October 14, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 14, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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