Acute Kidney InjuryNCT02978378
Renal Biomarkers to Predict Recovery Following Venoarterial Extracorporeal Membrane Oxygenation
An observational study of Acute Kidney Injury, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The investigators objective is to assess the utility of renal biomarkers in predicting renal recovery following institution of Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- biomarker levels
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 23 Mar 2018
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with cardiogenic shock and acute kidney injury requiring continuous renal replacement therapy
Who may be able to join
- age more than 18 years
- refractory or advanced cardiogenic shock prior to institution of VA-ECMO
Who cannot join
- History of chronic kidney disease prior to cardiogenic shock, as defined by estimated glomerular filtration rate (GFR) less than 60 mL per min
- Cognitive impairment
- Pregnant women
- patient or surrogate is not fluent in English
- Long-term immunosuppression
Trial locations and contacts
1 site in 1 country.
United States1 site
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
The investigators objective is to assess the utility of renal biomarkers in predicting renal recovery following institution of Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO). Tissue biomarkers of renal injury may provide a real-time indication of renal function and the likelihood of renal recovery in patients having cardiogenic shock and requiring VA-ECMO. In these patients, traditional markers of kidney function (urine output and serum Creatinine level) do not accurately represent renal function.
- Conditions
- Acute Kidney Injury
- Being tested
- biomarker levels
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biomarker levelsOther
The level of the biomarker hyaluronic acid will be measured
What is being measured
The primary outcome is the main question the study is designed to answer.
renal biomarker levels
Measured: through VA-ECMO decannulation, an average of 3 weeks
need for continuous renal replacement therapy at hospital discharge (Yes/No)
The need for continuous renal replacement therapy at hospital discharge will be assessed using hospital medical records
Measured: measured at hospital discharge, an average of 2-3 months following initial hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study start1 May 2017
- Primary completion23 Mar 2018
- Study completion23 Mar 2018
Why it stopped: insufficient patients to satisfy study protocol(s) inclusion criteria
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.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Bonavia, Penn State Health Milton S Hershey Medical Center
- Investigators
- Anthony Bonavia, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978378
- Sponsor's protocol ID
- STUDY00006088
- Status last verified
- Mar 2018
- First submitted
- 17 Nov 2016
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Biomarkers to Predict Recovery Following Venoarterial Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT02978378
- Acronym / sponsor ID
- STUDY00006088
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient patients to satisfy study protocol(s) inclusion criteria
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 23 Mar 2018 (actual)
- Study completion
- 23 Mar 2018 (actual)
- First posted
- 30 Nov 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 investigators objective is to assess the utility of renal biomarkers in predicting renal recovery following institution of Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO). Tissue biomarkers of renal injury may provide a real-time indication of renal function and the likelihood of renal recovery in patients having cardiogenic shock and requiring VA-ECMO. In these patients, traditional markers of kidney function (urine output and serum Creatinine level) do not accurately represent renal function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with cardiogenic shock and acute kidney injury requiring continuous renal replacement therapy
Key inclusion criteria (2 listed)
- age more than 18 years
- refractory or advanced cardiogenic shock prior to institution of VA-ECMO
Key exclusion criteria (5 listed)
- History of chronic kidney disease prior to cardiogenic shock, as defined by estimated glomerular filtration rate (GFR) less than 60 mL per min
- Cognitive impairment
- Pregnant women
- patient or surrogate is not fluent in English
- Long-term immunosuppression
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 |
|---|---|---|
| biomarker levelsThe level of the biomarker hyaluronic acid will be measured | Other | – |
Primary outcome
renal biomarker levels
Time frame: through VA-ECMO decannulation, an average of 3 weeks
need for continuous renal replacement therapy at hospital discharge (Yes/No)
Time frame: measured at hospital discharge, an average of 2-3 months following initial hospital admission
The need for continuous renal replacement therapy at hospital discharge will be assessed using hospital medical records
Results and safety
The study was stopped early (reason given: insufficient patients to satisfy study protocol(s) inclusion criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Anthony Bonavia principal investigator
Milton S. Hershey Medical 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 Milton S. Hershey Medical 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 2 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: stopped early, as of the sponsor's last update on 10 Dec 2024. 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?
The study was stopped early (reason given: insufficient patients to satisfy study protocol(s) inclusion criteria). Results are not available in the source record.
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?
renal biomarker levels (time frame: through VA-ECMO decannulation, an average of 3 weeks). 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 10 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.