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Assessment of Hydration Status Using Bioelectrical Impedance Vector Analysis

Sponsor
Catholic University of Pelotas (Other)
Overall Status
Completed
CT.gov ID
NCT02936440
Collaborator
(none)
224
Enrollment
3
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    224 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Hydration Status Using Bioelectrical Impedance Vector Analysis in Critical Patients With Acute Kidney Injury
    Study Start Date :
    May 1, 2011
    Actual Primary Completion Date :
    Aug 1, 2011
    Actual Study Completion Date :
    Aug 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    critical patients with AKI

    Critical patients with AKI will be followed up to 12 weeks after diagnosis

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of survivors in patients with AKI diagnosis during ICU [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Catholic University of Pelotas

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maria Cristina Gonzalez, Full Professor, Catholic University of Pelotas
    ClinicalTrials.gov Identifier:
    NCT02936440
    Other Study ID Numbers:
    • 2009/79
    First Posted:
    Oct 18, 2016
    Last Update Posted:
    Oct 18, 2016
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Maria Cristina Gonzalez, Full Professor, Catholic University of Pelotas
    acute kidney injury
    intensive care unit
    bioelectrical impedance analysis
    Additional relevant MeSH terms:
    Acute Kidney Injury
    Critical Illness

    Study Results

    No Results Posted as of Oct 18, 2016