Assessment of Hydration Status Using Bioelectrical Impedance Vector Analysis

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02936440
• Other study ID #: 2009/79
• Status: Completed
• Phase: N/A
• First received: October 14, 2016
• Last updated: October 14, 2016
• Start date: May 2011
• Est. completion date: August 2011

Study information

• Verified date: October 2016
• Source: Catholic University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness
• Wounds and Injuries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of Pelotas

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No