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Intensified Acute Kidney Disease Care to Reduce Chronic Kidney Disease (ISACC)

Primary Purpose

Acute Kidney Injury, Renal Insufficiency, Chronic, Acute Kidney Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multidisciplinary team (MDT) care and Acute kidney disease (AKD) clinic
Sponsored by
Taipei Medical University Shuang Ho Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Kidney Injury focused on measuring Acute Kidney Injury, Acute Kidney Disease, Chronic Kidney Disease, AKI, AKD, CKD, Decision Support Systems, Clinical, CDS

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 20 yrs
  • Severe AKD: Stage 2, Stage 3 and Dialysis-requiring AKD (AKD-D)

Exclusion Criteria:

  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intensified care

    Usual care

    Arm Description

    Experimental: Multidisciplinary team (MDT) care + Acute kidney disease (AKD) clinic Participants randomized to this arm will receive multidisciplinary team (MDT) care by a specialized medical team which is composed of nephrologist, pharmacist and dietitian. Besides intensified care, participants of this arm receive evaluation of biochemical and physiological renal function more frequently. In order to provide seamless care of this group, post-discharge acute kidney disease (AKD) clinic will also be arranged for them. Clinic visits consist of evaluation of renal function, reconciliation of medication and steering necessity of renal replacement therapy.

    No intervention: Usual care Participants randomized to this arm will receive usual care according to the medical decisions of principal care physician. Nephrologist consultation and nephrology outpatient clinic follow-up will be allowed. However, this group of patient will not have access to MDT care and AKD clinic.

    Outcomes

    Primary Outcome Measures

    Proportion of Major adverse kidney event
    Proportion of MAKE Renal progression to CKD Chronic dialysis (any 1 outpatient dialysis after discharge) Death

    Secondary Outcome Measures

    Mortality
    Proportion of death
    Chronic dialysis
    Proportion of chronic dialysis
    Renal progression
    Proportion of renal progression to CKD
    Time to MAKE
    Time to MAKE
    Time to death
    Time to death
    Time to chronic dialysis
    Time to chronic dialysis
    Time to renal progression to CKD
    Time to renal progression to CKD
    Time to first ER visit
    Time to first ER visit
    Time to first rehospitalization
    Time to first rehospitalization
    Time to first recurrence of AKI
    Time to first recurrence of AKI
    Proportion of MACE
    CVA, AMI, CHF, or cardiac revascularization procedure

    Full Information

    First Posted
    October 28, 2019
    Last Updated
    October 29, 2019
    Sponsor
    Taipei Medical University Shuang Ho Hospital
    Collaborators
    National Health Research Institutes, Taiwan, Taipei Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04145609
    Brief Title
    Intensified Acute Kidney Disease Care to Reduce Chronic Kidney Disease
    Acronym
    ISACC
    Official Title
    Strategies to Stop Acute Kidney Injury (AKI)-Acute Kidney Disease (AKD) -Chronic Kidney Disease (CKD) Continuum - Policy The Intensified AKD Care to Reduce CKD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Taipei Medical University Shuang Ho Hospital
    Collaborators
    National Health Research Institutes, Taiwan, Taipei Medical University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Strategies to stop AKI-AKD-CKD continuum - Policy is one of the collaborative projects, Strategies to stop AKI-AKD-CKD continuum, Epidemiology, Immunology, Repair, Artificial intelligence, and Policy (EIRAP). It is aimed to study effective interventional strategies that lower the incidence of CKD among patients with AKD. The intensified AKD care to reduce CKD (ISACC trial) is a prospective, open-labeled, randomized controlled trial is designed to evaluate the efficacy of multidisciplinary team care (MDT) model and acute kidney disease (AKD) clinic visits
    Detailed Description
    Acute kidney disease (AKD), defined as the ongoing renal function impairment between 7 days and 90 days following AKI, has been proposed as a window of intervention to prevent the occurrence of CKD. However, the effective therapeutic strategies of AKD care remain to be developed. We intend to conduct a prospective, randomized, open-label, behavioral interventional trial to validate the efficacy of multidisciplinary team (MDT) care model which aims to improve AKD care and to reduce de novo CKD incidence.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Kidney Injury, Renal Insufficiency, Chronic, Acute Kidney Disease, Decision Support Systems, Clinical
    Keywords
    Acute Kidney Injury, Acute Kidney Disease, Chronic Kidney Disease, AKI, AKD, CKD, Decision Support Systems, Clinical, CDS

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    690 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intensified care
    Arm Type
    Experimental
    Arm Description
    Experimental: Multidisciplinary team (MDT) care + Acute kidney disease (AKD) clinic Participants randomized to this arm will receive multidisciplinary team (MDT) care by a specialized medical team which is composed of nephrologist, pharmacist and dietitian. Besides intensified care, participants of this arm receive evaluation of biochemical and physiological renal function more frequently. In order to provide seamless care of this group, post-discharge acute kidney disease (AKD) clinic will also be arranged for them. Clinic visits consist of evaluation of renal function, reconciliation of medication and steering necessity of renal replacement therapy.
    Arm Title
    Usual care
    Arm Type
    No Intervention
    Arm Description
    No intervention: Usual care Participants randomized to this arm will receive usual care according to the medical decisions of principal care physician. Nephrologist consultation and nephrology outpatient clinic follow-up will be allowed. However, this group of patient will not have access to MDT care and AKD clinic.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Multidisciplinary team (MDT) care and Acute kidney disease (AKD) clinic
    Intervention Description
    Multidisciplinary team (MDT) care: NPDS care model Acute kidney disease (AKD) clinic: layered approach
    Primary Outcome Measure Information:
    Title
    Proportion of Major adverse kidney event
    Description
    Proportion of MAKE Renal progression to CKD Chronic dialysis (any 1 outpatient dialysis after discharge) Death
    Time Frame
    90days
    Secondary Outcome Measure Information:
    Title
    Mortality
    Description
    Proportion of death
    Time Frame
    30days, 60days, 90days, 180days, 360 days, 3years
    Title
    Chronic dialysis
    Description
    Proportion of chronic dialysis
    Time Frame
    90days, 180days, 360 days, 3years
    Title
    Renal progression
    Description
    Proportion of renal progression to CKD
    Time Frame
    90days, 180days, 360 days, 3years
    Title
    Time to MAKE
    Description
    Time to MAKE
    Time Frame
    90days, 180days, 1year (360days)
    Title
    Time to death
    Description
    Time to death
    Time Frame
    90days, 180days, 1year (360days)
    Title
    Time to chronic dialysis
    Description
    Time to chronic dialysis
    Time Frame
    90days, 180days, 1year (360days)
    Title
    Time to renal progression to CKD
    Description
    Time to renal progression to CKD
    Time Frame
    90days, 180days, 1year (360days)
    Title
    Time to first ER visit
    Description
    Time to first ER visit
    Time Frame
    90days, 180days, 1year (360days)
    Title
    Time to first rehospitalization
    Description
    Time to first rehospitalization
    Time Frame
    90days, 180days, 1year (360days)
    Title
    Time to first recurrence of AKI
    Description
    Time to first recurrence of AKI
    Time Frame
    90days, 180days, 1year (360days)
    Title
    Proportion of MACE
    Description
    CVA, AMI, CHF, or cardiac revascularization procedure
    Time Frame
    30days, 60days, 90days, 180days, 360 days, 3years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 20 yrs Severe AKD: Stage 2, Stage 3 and Dialysis-requiring AKD (AKD-D) Exclusion Criteria: Pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mai-Szu Wu, MD
    Phone
    +886-2-22490088
    Email
    maiszuwu@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yu-Wei Chen, MD
    Phone
    +886-2-22490088
    Ext
    2717
    Email
    b101091063@tmu.edu.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mai-Szu Wu
    Organizational Affiliation
    Shuang Ho Hospital, Taipei Medical University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Undecided
    Citations:
    PubMed Identifier
    28239173
    Citation
    Chawla LS, Bellomo R, Bihorac A, Goldstein SL, Siew ED, Bagshaw SM, Bittleman D, Cruz D, Endre Z, Fitzgerald RL, Forni L, Kane-Gill SL, Hoste E, Koyner J, Liu KD, Macedo E, Mehta R, Murray P, Nadim M, Ostermann M, Palevsky PM, Pannu N, Rosner M, Wald R, Zarbock A, Ronco C, Kellum JA; Acute Disease Quality Initiative Workgroup 16.. Acute kidney disease and renal recovery: consensus report of the Acute Disease Quality Initiative (ADQI) 16 Workgroup. Nat Rev Nephrol. 2017 Apr;13(4):241-257. doi: 10.1038/nrneph.2017.2. Epub 2017 Feb 27.
    Results Reference
    background
    PubMed Identifier
    30473140
    Citation
    See EJ, Jayasinghe K, Glassford N, Bailey M, Johnson DW, Polkinghorne KR, Toussaint ND, Bellomo R. Long-term risk of adverse outcomes after acute kidney injury: a systematic review and meta-analysis of cohort studies using consensus definitions of exposure. Kidney Int. 2019 Jan;95(1):160-172. doi: 10.1016/j.kint.2018.08.036. Epub 2018 Nov 23.
    Results Reference
    background

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    Intensified Acute Kidney Disease Care to Reduce Chronic Kidney Disease

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