Preventing Acute Kidney Injury

Sponsor

Atlantic Health System (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04376619

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Other: remote ischemic preconditioning Other: KDIGO guidelines	N/A

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

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

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.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)

Primary Purpose:

Prevention

Official Title:

Alert Kidney Intervention

Anticipated Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

number of participants who developed acute kidney injury [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 [during hospitalization, up to three months]
need for initiation of dialysis after acute kidney injury develops during the admission

Secondary Outcome Measures

number of participants who are placed on hospice or have expired [at time of admission when enrolled in study to 1 year post discharge]
death or placed on hospice
progression to chronic kidney disease [at time of admission when enrolled in study to 1 year post discharge]
measured by serum creatinine over 1 year on followup labs
number of participants who receive dialysis [at time of admission when enrolled in study to 1 year post discharge]
initiation of dialysis starting from at time of admission to 1 year post discharge
number of participants who are readmitted [discharged from when enrolled in study to 1 year post discharge]
readmissions to hospital within 1 year of first admission date
length of stay [during hospitalization, up to three months]
starting from onset of acute kidney injury measured by elevated creatinine 1.5 times baseline creatinine to last day of discharged

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Atlantic Health System

Investigators

Principal Investigator: Shivangi Patel, M.D., atlantich health system

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shivangi K. Patel, Principal Investigator, Atlantic Health System

ClinicalTrials.gov Identifier:

NCT04376619

Other Study ID Numbers:

1527104-1

First Posted:

May 6, 2020

Last Update Posted:

Oct 22, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acute Kidney Injury

Study Results

No Results Posted as of Oct 22, 2021