Preventing Acute Kidney Injury

Study Overview
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Brief Summary
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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
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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.

Official Title
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Alert Kidney Intervention

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Other: remote ischemic preconditioning
* Other: KDIGO guidelines


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KDIGO guidelines<br>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 | Other: KDIGO guidelines<br>* KDIGO stands for Kidney disease Improving global outcomes guidelines, and have guidelines for prevention and treatment of AKI which is considered standard of care.<br>|
| Experimental: RIPC<br>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 | Other: remote ischemic preconditioning<br>* inflation and deflation of cuff 5min each cycle repeated 3 times<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants who developed acute kidney injury | development of acute kidney injury as measured by serum creatinine 1.5 times more then baseline | 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 | during hospitalization, up to three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants who are placed on hospice or have expired | death or placed on hospice | 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 | 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 | 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 | 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 | during hospitalization, up to three months |