Preventing Acute Kidney Injury

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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: KDIGO guidelines; Other: remote ischemic preconditioning

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KDIGO guidelines; 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; KDIGO stands for Kidney disease Improving global outcomes guidelines, and have guidelines for prevention and treatment of AKI which is considered standard of care.
Experimental: RIPC; 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; inflation and deflation of cuff 5min each cycle repeated 3 times

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Atlantic Health System
• Investigators: Principal Investigator: Shivangi Patel, M.D., atlantich health system

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 1527104-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: excel file that is password protected, only to those involved in the study directly
• IPD Sharing Time Frame: six months at end of study and for 3 more months post study completion
• IPD Sharing Access Criteria: must be involved in implementing /executing the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No