Clinical trial NCT04376619: Preventing Acute Kidney Injury
Official title: Alert Kidney Intervention
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* End stage renal disease
* estimated glomerular filtration rate less then 20
* Left ventricular assist device patients
* observation status
* hospice patients
* pregnancy
* 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

Primary outcomes:
measure: number of participants who developed acute kidney injury
timeFrame: during hospitalization, up to three months
measure: number of participants who required dialysis
timeFrame: during hospitalization, up to three months
Secondary outcomes:
measure: number of participants who are placed on hospice or have expired
timeFrame: at time of admission when enrolled in study to 1 year post discharge
measure: progression to chronic kidney disease
timeFrame: at time of admission when enrolled in study to 1 year post discharge
measure: number of participants who receive dialysis
timeFrame: at time of admission when enrolled in study to 1 year post discharge
measure: number of participants who are readmitted
timeFrame: discharged from when enrolled in study to 1 year post discharge
measure: length of stay
timeFrame: during hospitalization, up to three months
Other outcomes:
Locations:
Study officials:
affiliation: atlantich health system
name: Shivangi Patel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: