Acute Kidney InjuryNCT04376619
Preventing Acute Kidney Injury
A study testing remote ischemic preconditioning and KDIGO guidelines in people with Acute Kidney Injury, run by Atlantic Health System.
Trial summary
Acute kidney injury increases the risk for chronic kidney disease, length of stay, readmissions and mortality. Currently the only way to diagnose acute kidney injury is with a serum creatinine or drop in urine output. Biomarkers for acute kidney injury are well elevated before rise in creatinine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- remote ischemic preconditioning and KDIGO guidelines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 1 Aug 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- any admitted patients that are not excluded by exclusion criteria
- Patients who's creatinine returns to baseline after admitted can be included in study if patient still remains admitted.
Who cannot join
- End stage renal disease
- estimated glomerular filtration rate less then 20
- Left ventricular assist device patients
- observation status
- hospice patients
- pregnancy
Show all 14Show fewer
- age less then 18
- acute kidney injury on admission defined as 1.5 times elevated creatinine prior to last admission's creatinine
- nephrology consult already placed
- renal transplant or nephrectomy within 1 year
- Patients unable to provide consent
- exclusion for remote ischemic preconditioning in addition to above exclusion will be:
- symptoms or diagnosis of peripheral arterial disease
- Patients in shock defined by requiring inotropes or vasopressors
About this study
Official title: Alert Kidney Intervention
Acute kidney injury increases the risk for chronic kidney disease, length of stay, readmissions and mortality. Currently the only way to diagnose acute kidney injury is with a serum creatinine or drop in urine output. Biomarkers for acute kidney injury are well elevated before rise in creatinine. Hypothesis is that by implementing an electronic alert system with an algorithm followed by remote ischemic preconditioning will prevent acute kidney injury.
Read the detailed description
The propose study is to incorporate an alert system in current medical health system and an algorithm will be used to activate clinicians and Nephrologist to confirm if patient is at high risk. Once identified as high risk the clinician and/or nephrologist will intervene and change current management if needed. First phase of study will look at an alert system and algorithm was enough to lower incidence of acute kidney injury. Phase 2 will also use alert system and algorithm that will be further randomized those that are identified as high risk for acute kidney injury to remote ischemic preconditioning.
- Conditions
- Acute Kidney Injury
- Being tested
- remote ischemic preconditioning, KDIGO guidelines
- 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.
remote ischemic preconditioningOther
inflation and deflation of cuff 5min each cycle repeated 3 times
KDIGO guidelinesOther
KDIGO stands for Kidney disease Improving global outcomes guidelines, and have guidelines for prevention and treatment of AKI which is considered standard of care.
| Study group | Role | What they receive |
|---|---|---|
| KDIGO guidelines | Experimental | Part 1 of study, those identified as high risk for AKI then will have Kidney Disease Global Improving outcomes guideline implemented to see if this reduces incidence of AKI Receives: Other: KDIGO guidelines |
| RIPC | Experimental | part 2 of study, those identified as high risk of AKI will have Kidney Disease Improving Global Outcomes guidelines and RIPC implemented to see if this reduces incidence of AKI compared to part 2 of study Receives: Other: remote ischemic preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants who developed acute kidney injury
development of acute kidney injury as measured by serum creatinine 1.5 times more then baseline
Measured: during hospitalization, up to three months
number of participants who required dialysis
need for initiation of dialysis after acute kidney injury develops during the admission
Measured: during hospitalization, up to three months
Secondary outcomes (5)
number of participants who are placed on hospice or have expired
death or placed on hospice
Measured: at time of admission when enrolled in study to 1 year post discharge
progression to chronic kidney disease
measured by serum creatinine over 1 year on followup labs
Measured: at time of admission when enrolled in study to 1 year post discharge
number of participants who receive dialysis
initiation of dialysis starting from at time of admission to 1 year post discharge
Measured: at time of admission when enrolled in study to 1 year post discharge
number of participants who are readmitted
readmissions to hospital within 1 year of first admission date
Measured: discharged from when enrolled in study to 1 year post discharge
length of stay
starting from onset of acute kidney injury measured by elevated creatinine 1.5 times baseline creatinine to last day of discharged
Measured: during hospitalization, up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Why it stopped: never was able to recruit
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Two part study: all patients will be triaged by alert system whether they are high risk for acute kidney injury and those patients that are identified as high risk for AKI have standard of care implemented by following kidney disease improving global outcomes guidelines in preventing AKI and part 2 will perform procedure called remote ischemic preconditioning in addition to standard of care in part1 in those patients that are identified as high risk for acute kidney injury.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shivangi K. Patel, Atlantic Health System
- Investigators
- Shivangi Patel, M.D., Principal investigator, atlantich health system
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376619
- Sponsor's protocol ID
- 1527104-1
- Status last verified
- Oct 2021
- First submitted
- 27 Apr 2020
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: excel file that is password protected, only to those involved in the study directly
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alert Kidney Intervention
- ClinicalTrials.gov ID
- NCT04376619
- Acronym / sponsor ID
- 1527104-1
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: never was able to recruit
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 6 May 2020 (actual)
- 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.
Acute kidney injury increases the risk for chronic kidney disease, length of stay, readmissions and mortality. Currently the only way to diagnose acute kidney injury is with a serum creatinine or drop in urine output. Biomarkers for acute kidney injury are well elevated before rise in creatinine. Hypothesis is that by implementing an electronic alert system with an algorithm followed by remote ischemic preconditioning will prevent acute kidney injury.
Detailed description
The propose study is to incorporate an alert system in current medical health system and an algorithm will be used to activate clinicians and Nephrologist to confirm if patient is at high risk. Once identified as high risk the clinician and/or nephrologist will intervene and change current management if needed. First phase of study will look at an alert system and algorithm was enough to lower incidence of acute kidney injury. Phase 2 will also use alert system and algorithm that will be further randomized those that are identified as high risk for acute kidney injury to remote ischemic preconditioning.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two part study: all patients will be triaged by alert system whether they are high risk for acute kidney injury and those patients that are identified as high risk for AKI have standard of care implemented by following kidney disease improving global outcomes guidelines in preventing AKI and part 2 will perform procedure called remote ischemic preconditioning in addition to standard of care in part1 in those patients that are identified as high risk for acute kidney injury.
| Arm | Type | Receives |
|---|---|---|
| KDIGO guidelines | Experimental | Other: KDIGO guidelinesPart 1 of study, those identified as high risk for AKI then will have Kidney Disease Global Improving outcomes guideline implemented to see if this reduces incidence of AKI |
| RIPC | Experimental | Other: remote ischemic preconditioningpart 2 of study, those identified as high risk of AKI will have Kidney Disease Improving Global Outcomes guidelines and RIPC implemented to see if this reduces incidence of AKI compared to part 2 of study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- any admitted patients that are not excluded by exclusion criteria
- Patients who's creatinine returns to baseline after admitted can be included in study if patient still remains admitted.
Key exclusion criteria (14 listed)
- End stage renal disease
- estimated glomerular filtration rate less then 20
- Left ventricular assist device patients
- observation status
- hospice patients
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 |
|---|---|---|
| remote ischemic preconditioninginflation and deflation of cuff 5min each cycle repeated 3 times | Other | RIPC |
| KDIGO guidelinesKDIGO stands for Kidney disease Improving global outcomes guidelines, and have guidelines for prevention and treatment of AKI which is considered standard of care. | Other | KDIGO guidelines |
Primary outcome
number of participants who developed acute kidney injury
Time frame: during hospitalization, up to three months
development of acute kidney injury as measured by serum creatinine 1.5 times more then baseline
number of participants who required dialysis
Time frame: during hospitalization, up to three months
need for initiation of dialysis after acute kidney injury develops during the admission
5 secondary outcomes
number of participants who are placed on hospice or have expired
Time frame: at time of admission when enrolled in study to 1 year post discharge
progression to chronic kidney disease
Time frame: at time of admission when enrolled in study to 1 year post discharge
number of participants who receive dialysis
Time frame: at time of admission when enrolled in study to 1 year post discharge
number of participants who are readmitted
Time frame: discharged from when enrolled in study to 1 year post discharge
length of stay
Time frame: during hospitalization, up to three months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: Yes. excel file that is password protected, only to those involved in the study directly
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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.
Shivangi Patel, M.D. principal investigator
atlantich health system
Questions about this trial
What is this clinical trial studying?
A study testing remote ischemic preconditioning and KDIGO guidelines in people with Acute Kidney Injury, run by Atlantic Health System.
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 14 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: withdrawn, as of the sponsor's last update on 22 Oct 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
number of participants who developed acute kidney injury (time frame: during hospitalization, up to three months). 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 22 Oct 2021.