Bioimpedance Analysis in Septic Intensive Care Unit (ICU) Patients

NCT01379404 | Completed

• 1 other identifier: StJoseph - BIOVISION
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with severe infections initially require large amounts of fluid as part of resuscitation. Later on however, problems may arise from excess fluid such as increased time on a ventilator and kidney damage. The amount of fluid a patient has is difficult to assess. One approach is to determine the amount of fluid that is present in a large central vein. This can be done by physical examination of the jugular veins, or by placing a catheter within the vein. Unfortunately this method is unreliable and does not predict the amount of fluid a patient has. Bioimpedance analysis (BIA), is a device that can determine the amount of fluid in the body by measuring the body's electrical properties. It is a quick and painless test that assesses volume. The primary objective of this study is to determine if BIA measurements are associated with patient important outcomes such as time on a ventilator, risk of kidney failure requiring dialysis and death. We will also determine whether BIA is a measure of fluid status in ICU patients. This study will assess feasibility in establishing a multi-centre study assessing if BIA's role in predicting adverse outcomes and thereby prognosis and fluid status. We hypothesize that shorter vector lengths will be associated with hypervolemia and less ventilator free days.

Conditions

Sepsis

Keywords

sepsis, fluid status, BIA, CVP

Outcome Measures

Primary Outcomes (1)

• Ventilator free days

  30 days

Secondary Outcomes (4)

• Correlation of BIA vector length with Central venous pressure, edema score, chest x-ray score, and net fluid balance

  Time of enrollment (multivariate analysis at day 2 )

• Acute Kidney Injury

  60 days

• Time until ICU discharge

  60 days

• Mortality

  60 days

Interventions

Bioelectric Impedance Analysis DEVICE

Bioimpedance devices are compact, portable, easy to use, relatively inexpensive and can be used to make repeated non-invasive measurements. Bioimpedance measures the impedance to the flow of an electric current through body fluids and consists of two components, resistance and reactance. Resistance is a measure of electrical current a substance will oppose and is inversely related to tissue fluid content. Reactance is the capacitative component of impedance and indicates energy stored by cell membranes and organelles; due to this property, reactance is associated with tissue cell mass. These raw measures provide a measure of volume as determined by vector length and the RXc graph method.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult patients (\>17 years) admitted to the ICU at SJHH who present with SIRS requiring positive pressure ventilation via endotracheal tube and have a clinical suspicion of infection. Consecutive sampling.

You may qualify if:

• adult patients
• high clinical suspicion for infection
• require positive pressure ventilation
• supraclavicular central line for central venous pressure measurement

You may not qualify if:

• Substitute decision maker unable to consent
• amputation
• pacemaker
• pregnant
• require longterm hemodialysis

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• McMaster University: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (1)

• Rochwerg B, Cheung JH, Ribic CM, Lalji F, Clarke FJ, Gantareddy S, Ranganath N, Walele A, McDonald E, Meade MO, Cook DJ, Wilkieson TT, Clase CM, Margetts PJ, Gangji AS. Assessment of Postresuscitation Volume Status by Bioimpedance Analysis in Patients with Sepsis in the Intensive Care Unit: A Pilot Observational Study. Can Respir J. 2016;2016:8671742. doi: 10.1155/2016/8671742. Epub 2016 Aug 15.

  PMID: 27597811 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood only for chemistry.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Azim Gangji, MD, MSc

  St. Joseph's Health Care London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: June 23, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

CA (1)