Preventing Acute Kidney Injury

Acute Kidney Injury Clinical Trial

Official title:

Alert Kidney Intervention

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04376619
• Other study ID #: 1527104-1
• Status: Withdrawn
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: October 2021
• Source: Atlantic Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Hypothesis is that by implementing an electronic alert system with an algorithm followed by remote ischemic preconditioning will prevent acute kidney injury.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Other:
• remote ischemic preconditioning
inflation and deflation of cuff 5min each cycle repeated 3 times
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Atlantic Health System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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