SepsisBIOVISIONNCT01379404
Bioimpedance Analysis in Septic Intensive Care Unit (ICU) Patients
An observational study of Sepsis, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Bioelectric Impedance Analysis
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2011to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- adult patients
- high clinical suspicion for infection
- require positive pressure ventilation
- supraclavicular central line for central venous pressure measurement
Who cannot join
- Substitute decision maker unable to consent
- amputation
- pacemaker
- pregnant
- require longterm hemodialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Bio-impedance Analysis Predict Volume Overload States and Clinically Relevant Outcomes in Septic Intensive Care Unit (ICU) Patients With Acute Kidney Injury? A Prospective Observational Study
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.
Read the detailed description
Overall Objective: Persistent hypervolemia following the initial resuscitative phase in sepsis has been shown to predict morbidity and mortality. In patients with sepsis in the intensive care unit (ICU) fluid accumulation is associated with a significant increase in duration of ventilation, development of acute kidney injury (AKI) requiring dialysis and increased ICU length of stay. It is essential to be able to identify and characterize the transition from necessary fluid resuscitation to harmful fluid volume accumulation. However, current methods for assessing volume status in the ICU are imprecise. Bioelectric impedance analysis (BIA) offers a well established and easy to perform bedside technique of volume assessment. Our main objective is to prospectively determine if bio-impedance derived measures are associated with patient important outcomes including ventilator free days, AKI requiring dialysis and overall mortality in septic ICU patients. In addition, we will also assess whether BIA derived measures of volume are associated with other measures of volume status.
Hypothesis #1: Bio-impedance derived measures (phase angle, vector length) will be predict ventilator-free days by day 30 and a composite outcome of ICU patients with AKI requiring dialysis and overall mortality .
Aim #1: To assess whether a change in bio-impedance vector length (a measure of volume status) between day 3 and day 7 post- admission to the ICU predicts ventilator-free days by day 30. Secondary outcomes are mortality, AKI and length of stay in ICU.
Hypothesis #2: BIA derived volume measures (vector length and the RXc graph method) will be associated with other clinical, invasive and biochemical measures of volume status
Aim #2: To determine if BIA derived volume measures are associated with other measures of volume status including central venous pressure, N- brain natriuretic peptide (N-BNP) and physical examination findings.
Relevance: Chronic fluid overload states in ICU patients are associated with adverse clinical outcomes including prolonged ventilation, mortality, AKI and increased length of stay in the ICU. However current methods are inadequate to assess volume status accurately. This pilot observational study will determine whether implementation of bio-impedance is useful for identifying volume overload in ICU patients with sepsis. We plan to investigate whether a correlation exists between a change in vector length between days 3 and 7 post admission to the ICU and an important patient outcome of ventilator free days within the first 30 days post-enrollment. This study will assess feasibility to inform a larger multi-centre observational trial adequately powered to evaluate volume overload states as determined by bioimpedance in ICU patients with systemic inflammatory response syndrome (SIRS) and patient-important outcomes.
- Conditions
- Sepsis
- Being tested
- Bioelectric Impedance Analysis
- Keywords
- sepsis, fluid status, BIA, CVP
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioelectric Impedance AnalysisDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator free days
Measured: 30 days
Secondary outcomes (4)
Correlation of BIA vector length with Central venous pressure, edema score, chest x-ray score, and net fluid balance
To be done by multivariate analysis at day 2 vector length measurement.
Measured: Time of enrollment (multivariate analysis at day 2 )
Acute Kidney Injury
Measured: 60 days
Time until ICU discharge
Measured: 60 days
Mortality
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, Azim Gangji, St. Joseph's Healthcare Hamilton
- Investigators
- Azim Gangji, MD, MSc, Principal investigator, St. Joseph's Health Care London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379404
- Sponsor's protocol ID
- StJoseph - BIOVISION
- Acronym
- BIOVISION
- Status last verified
- May 2015
- First submitted
- 7 Jun 2011
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27597811
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Bio-impedance Analysis Predict Volume Overload States and Clinically Relevant Outcomes in Septic Intensive Care Unit (ICU) Patients With Acute Kidney Injury? A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT01379404
- Acronym / sponsor ID
- BIOVISION / StJoseph - BIOVISION
- Conditions
- Sepsis
- Keywords
- sepsis, fluid status, BIA, CVP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- Feb 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Overall Objective: Persistent hypervolemia following the initial resuscitative phase in sepsis has been shown to predict morbidity and mortality. In patients with sepsis in the intensive care unit (ICU) fluid accumulation is associated with a significant increase in duration of ventilation, development of acute kidney injury (AKI) requiring dialysis and increased ICU length of stay. It is essential to be able to identify and characterize the transition from necessary fluid resuscitation to harmful fluid volume accumulation. However, current methods for assessing volume status in the ICU are imprecise. Bioelectric impedance analysis (BIA) offers a well established and easy to perform bedside technique of volume assessment. Our main objective is to prospectively determine if bio-impedance derived measures are associated with patient important outcomes including ventilator free days, AKI requiring dialysis and overall mortality in septic ICU patients. In addition, we will also assess whether BIA derived measures of volume are associated with other measures of volume status.
Hypothesis #1: Bio-impedance derived measures (phase angle, vector length) will be predict ventilator-free days by day 30 and a composite outcome of ICU patients with AKI requiring dialysis and overall mortality .
Aim #1: To assess whether a change in bio-impedance vector length (a measure of volume status) between day 3 and day 7 post- admission to the ICU predicts ventilator-free days by day 30. Secondary outcomes are mortality, AKI and length of stay in ICU.
Hypothesis #2: BIA derived volume measures (vector length and the RXc graph method) will be associated with other clinical, invasive and biochemical measures of volume status
Aim #2: To determine if BIA derived volume measures are associated with other measures of volume status including central venous pressure, N- brain natriuretic peptide (N-BNP) and physical examination findings.
Relevance: Chronic fluid overload states in ICU patients are associated with adverse clinical outcomes including prolonged ventilation, mortality, AKI and increased length of stay in the ICU. However current methods are inadequate to assess volume status accurately. This pilot observational study will determine whether implementation of bio-impedance is useful for identifying volume overload in ICU patients with sepsis. We plan to investigate whether a correlation exists between a change in vector length between days 3 and 7 post admission to the ICU and an important patient outcome of ventilator free days within the first 30 days post-enrollment. This study will assess feasibility to inform a larger multi-centre observational trial adequately powered to evaluate volume overload states as determined by bioimpedance in ICU patients with systemic inflammatory response syndrome (SIRS) and patient-important outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- adult patients
- high clinical suspicion for infection
- require positive pressure ventilation
- supraclavicular central line for central venous pressure measurement
Key exclusion criteria (5 listed)
- Substitute decision maker unable to consent
- amputation
- pacemaker
- pregnant
- require longterm hemodialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioelectric Impedance AnalysisBioimpedance 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. | Device | – |
Primary outcome
Ventilator free days
Time frame: 30 days
4 secondary outcomes
Correlation of BIA vector length with Central venous pressure, edema score, chest x-ray score, and net fluid balance
Time frame: Time of enrollment (multivariate analysis at day 2 )
Acute Kidney Injury
Time frame: 60 days
Time until ICU discharge
Time frame: 60 days
Mortality
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
- Derived from this study: PubMed 27597811Rochwerg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azim Gangji, MD, MSc principal investigator
St. Joseph's Health Care London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator free days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01379404, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.