Acute Kidney InjuryNCT02165072
Inferior Vena cavaCollapsibility Index in Patients With Acute Kidney Injury
An observational study of Acute Kidney Injury, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
This is an observational study that will examine the possibility of determining the type of Acute Kidney Injury (AKI) using bedside ultrasound machines. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Oct 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects ages 18-89 years with AKI (creatinine of 1.7mg/100ml or higher for less than 24 hours from baseline creatinine ≤1.2 or with unknown baseline creatinine). Standard of care treatment will not be different for patients taking part in this study. Participants will have bedside ultrasounds on days 0, 1, and 3, and baseline and follow-up data will be collected from medical records.
Who may be able to join
- Creatinine of 1.7 mg/100ml or higher for less than 24 hours from baseline creatinine ≤1.2 or with unknown baseline creatinine
- Age range: 18-89 years
- Age range ≥ 18
Who cannot join
- 1. Only chronic renal disease will exclude a patient from our study regardless of past medical history and medications they are taking. (For the purposes of this study, any patient with creatinine higher than 1.2 mg /100ml for more than 24 hours will be identified as having chronic renal disease.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech Univrsity Health Science Center
Lubbock, Texas, 79430
About this study
Official title: Inferior Vena Cava Collapsibility Index in Patients With Acute Kidney Injury
This is an observational study that will examine the possibility of determining the type of Acute Kidney Injury (AKI) using bedside ultrasound machines.
Read the detailed description
The investigators hypothesize that different types of AKI (pre-renal, renal, and post-renal) are associated with different inferior vena cava diameters and collapsibility index. The investigators will include subjects ages 18-89 years with AKI (creatinine of 2mg/100ml or higher for less than 24 hours from baseline creatinine ≤1.2 or with unknown baseline creatinine). Standard of care treatment will not be different for patients taking part in this study. Participants will have bedside ultrasounds on days 0, 1, and 3, and baseline and follow-up data will be collected from medical records.
- Conditions
- Acute Kidney Injury
- Keywords
- Inferior vena cava, Kidney injury, Ultrasound
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum and Minimum Diameters of the Inferior Vena Cava in Patients With Acute Kidney Injury
The investigators will measure the maximum and minimum diameters of the inferior vena cava with patients with acute kidney injury.
Measured: Day 1 of ICU admission
Percent Collapse of the Inferior Vena Cava in Patients With Acute Kidney Injury
The investigators will measure the maximum and minimum diameters of the inferior vena cava with patients with acute kidney injury and calculate the percent change between the maximum and minimum diameters.
Measured: Day 1 of ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth M Nugent, MD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165072
- Sponsor's protocol ID
- L14-052
- Status last verified
- Jun 2016
- First submitted
- 13 Jun 2014
- Last updated
- 23 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inferior Vena Cava Collapsibility Index in Patients With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT02165072
- Acronym / sponsor ID
- L14-052
- Conditions
- Acute Kidney Injury
- Keywords
- Inferior vena cava, Kidney injury, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Jun 2014 (estimated)
- Results
- Posted 23 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study that will examine the possibility of determining the type of Acute Kidney Injury (AKI) using bedside ultrasound machines.
Detailed description
The investigators hypothesize that different types of AKI (pre-renal, renal, and post-renal) are associated with different inferior vena cava diameters and collapsibility index. The investigators will include subjects ages 18-89 years with AKI (creatinine of 2mg/100ml or higher for less than 24 hours from baseline creatinine ≤1.2 or with unknown baseline creatinine). Standard of care treatment will not be different for patients taking part in this study. Participants will have bedside ultrasounds on days 0, 1, and 3, and baseline and follow-up data will be collected from medical records.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects ages 18-89 years with AKI (creatinine of 1.7mg/100ml or higher for less than 24 hours from baseline creatinine ≤1.2 or with unknown baseline creatinine). Standard of care treatment will not be different for patients taking part in this study. Participants will have bedside ultrasounds on days 0, 1, and 3, and baseline and follow-up data will be collected from medical records.
Key inclusion criteria (3 listed)
- Creatinine of 1.7 mg/100ml or higher for less than 24 hours from baseline creatinine ≤1.2 or with unknown baseline creatinine
- Age range: 18-89 years
- Age range ≥ 18
Key exclusion criteria (1 listed)
- 1. Only chronic renal disease will exclude a patient from our study regardless of past medical history and medications they are taking. (For the purposes of this study, any patient with creatinine higher than 1.2 mg /100ml for more than 24 hours will be identified as having chronic renal disease.)
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
Maximum and Minimum Diameters of the Inferior Vena Cava in Patients With Acute Kidney Injury
Time frame: Day 1 of ICU admission
The investigators will measure the maximum and minimum diameters of the inferior vena cava with patients with acute kidney injury.
Percent Collapse of the Inferior Vena Cava in Patients With Acute Kidney Injury
Time frame: Day 1 of ICU admission
The investigators will measure the maximum and minimum diameters of the inferior vena cava with patients with acute kidney injury and calculate the percent change between the maximum and minimum diameters.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Kenneth M Nugent, MD principal investigator
Texas Tech University Health Sciences Center
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 Acute Kidney Injury, run by Texas Tech University Health Sciences Center at 1 site in United States.
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 3 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 23 Jun 2016. 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 United States. 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?
Yes. Results are posted in the registry (first posted 23 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum and Minimum Diameters of the Inferior Vena Cava in Patients With Acute Kidney Injury (time frame: Day 1 of ICU admission). The study lists 2 primary outcomes in all. 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 23 Jun 2016.