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Preventing Acute Kidney Injury

Primary Purpose

Acute Kidney Injury

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
remote ischemic preconditioning
KDIGO guidelines
Sponsored by
Atlantic Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    KDIGO guidelines

    RIPC

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    number of participants who developed acute kidney injury
    development of acute kidney injury as measured by serum creatinine 1.5 times more then baseline
    number of participants who required dialysis
    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
    death or placed on hospice
    progression to chronic kidney disease
    measured by serum creatinine over 1 year on followup labs
    number of participants who receive dialysis
    initiation of dialysis starting from at time of admission to 1 year post discharge
    number of participants who are readmitted
    readmissions to hospital within 1 year of first admission date
    length of stay
    starting from onset of acute kidney injury measured by elevated creatinine 1.5 times baseline creatinine to last day of discharged

    Full Information

    First Posted
    April 27, 2020
    Last Updated
    October 15, 2021
    Sponsor
    Atlantic Health System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04376619
    Brief Title
    Preventing Acute Kidney Injury
    Official Title
    Alert Kidney Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    never was able to recruit
    Study Start Date
    August 1, 2020 (Anticipated)
    Primary Completion Date
    April 1, 2021 (Anticipated)
    Study Completion Date
    August 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Atlantic Health System

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Kidney Injury

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    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)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    KDIGO guidelines
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    RIPC
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    remote ischemic preconditioning
    Intervention Description
    inflation and deflation of cuff 5min each cycle repeated 3 times
    Intervention Type
    Other
    Intervention Name(s)
    KDIGO guidelines
    Intervention Description
    KDIGO stands for Kidney disease Improving global outcomes guidelines, and have guidelines for prevention and treatment of AKI which is considered standard of care.
    Primary Outcome Measure Information:
    Title
    number of participants who developed acute kidney injury
    Description
    development of acute kidney injury as measured by serum creatinine 1.5 times more then baseline
    Time Frame
    during hospitalization, up to three months
    Title
    number of participants who required dialysis
    Description
    need for initiation of dialysis after acute kidney injury develops during the admission
    Time Frame
    during hospitalization, up to three months
    Secondary Outcome Measure Information:
    Title
    number of participants who are placed on hospice or have expired
    Description
    death or placed on hospice
    Time Frame
    at time of admission when enrolled in study to 1 year post discharge
    Title
    progression to chronic kidney disease
    Description
    measured by serum creatinine over 1 year on followup labs
    Time Frame
    at time of admission when enrolled in study to 1 year post discharge
    Title
    number of participants who receive dialysis
    Description
    initiation of dialysis starting from at time of admission to 1 year post discharge
    Time Frame
    at time of admission when enrolled in study to 1 year post discharge
    Title
    number of participants who are readmitted
    Description
    readmissions to hospital within 1 year of first admission date
    Time Frame
    discharged from when enrolled in study to 1 year post discharge
    Title
    length of stay
    Description
    starting from onset of acute kidney injury measured by elevated creatinine 1.5 times baseline creatinine to last day of discharged
    Time Frame
    during hospitalization, up to three months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shivangi Patel, M.D.
    Organizational Affiliation
    atlantich health system
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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

    Learn more about this trial

    Preventing Acute Kidney Injury

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