NCT02936440

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

October 14, 2016

Last Update Submit

October 14, 2016

Conditions

Keywords

acute kidney injuryintensive care unitbioelectrical impedance analysis

Outcome Measures

Primary Outcomes (1)

  • Proportion of survivors in patients with AKI diagnosis during ICU

    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

Study Arms (1)

critical patients with AKI

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intensive care patients who developed acute kidney injury after ICU admission

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Kidney InjuryCritical Illness

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Cristina Gonzalez, MD, PhD

    Catholic University of Pelotas

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 18, 2016

Study Start

May 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

October 18, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share