Acute Kidney InjuryNCT02936440
Assessment of Hydration Status Using Bioelectrical Impedance Vector Analysis
An observational study of Acute Kidney Injury and Critical Illness, run by Catholic University of Pelotas.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Critical Illness
- How many people
- 224 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Aug 2011
- 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: Intensive care patients who developed acute kidney injury after ICU admission
Who may be able to join
- Patients older than 18 years who developed acute kidney injury after admission in Intensive Care Unit
Who cannot join
- Chronic kidney injury, dialysis-dependent chronic kidney injury, acute kidney injury before ICU admission, kidney transplant, morbidity obesity and limb amputation.
About this study
Official title: Assessment of Hydration Status Using Bioelectrical Impedance Vector Analysis in Critical Patients With Acute Kidney Injury
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.
Read the 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.
- Conditions
- Acute Kidney Injury, Critical Illness
- Keywords
- acute kidney injury, intensive care unit, bioelectrical impedance analysis
- Medical subject headings
- Acute Kidney Injury, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| critical patients with AKI | Critical patients with AKI will be followed up to 12 weeks after diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 weeks after AKI diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startMay 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies 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
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Cristina Gonzalez, Catholic University of Pelotas
- Investigators
- Maria Cristina Gonzalez, MD, PhD, Study chair, Catholic University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936440
- Sponsor's protocol ID
- 2009/79
- Status last verified
- Oct 2016
- First submitted
- 14 Oct 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hydration Status Using Bioelectrical Impedance Vector Analysis in Critical Patients With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT02936440
- Acronym / sponsor ID
- 2009/79
- Conditions
- Acute Kidney Injury, Critical Illness
- Keywords
- acute kidney injury, intensive care unit, bioelectrical impedance analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Catholic University of PelotasUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 18 Oct 2016 (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.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| critical patients with AKI | – | –Critical patients with AKI will be followed up to 12 weeks after diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care patients who developed acute kidney injury after ICU admission
Key inclusion criteria (1 listed)
- Patients older than 18 years who developed acute kidney injury after admission in Intensive Care Unit
Key exclusion criteria (1 listed)
- Chronic kidney injury, dialysis-dependent chronic kidney injury, acute kidney injury before ICU admission, kidney transplant, morbidity obesity and limb amputation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of survivors in patients with AKI diagnosis during ICU
Time frame: 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.
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 18 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Maria Cristina Gonzalez, MD, PhD study chair
Catholic University of Pelotas
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Critical Illness, run by Catholic University of Pelotas.
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 1 inclusion and 1 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 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Proportion of survivors in patients with AKI diagnosis during ICU (time frame: Up to 12 weeks after AKI diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2016.