Intensified Acute Kidney Disease Care to Reduce Chronic Kidney Disease

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

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.

Interventions

  • Behavioral: Multidisciplinary team (MDT) care and Acute kidney disease (AKD) clinic
    • Multidisciplinary team (MDT) care: NPDS care model Acute kidney disease (AKD) clinic: layered approach

Arms, Groups and Cohorts

  • Experimental: Intensified care
    • 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
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of Major adverse kidney event
    • Time Frame: 90days
    • Proportion of MAKE Renal progression to CKD Chronic dialysis (any 1 outpatient dialysis after discharge) Death

Secondary Measures

  • Mortality
    • Time Frame: 30days, 60days, 90days, 180days, 360 days, 3years
    • Proportion of death
  • Chronic dialysis
    • Time Frame: 90days, 180days, 360 days, 3years
    • Proportion of chronic dialysis
  • Renal progression
    • Time Frame: 90days, 180days, 360 days, 3years
    • Proportion of renal progression to CKD
  • Time to MAKE
    • Time Frame: 90days, 180days, 1year (360days)
    • Time to MAKE
  • Time to death
    • Time Frame: 90days, 180days, 1year (360days)
    • Time to death
  • Time to chronic dialysis
    • Time Frame: 90days, 180days, 1year (360days)
    • Time to chronic dialysis
  • Time to renal progression to CKD
    • Time Frame: 90days, 180days, 1year (360days)
    • Time to renal progression to CKD
  • Time to first ER visit
    • Time Frame: 90days, 180days, 1year (360days)
    • Time to first ER visit
  • Time to first rehospitalization
    • Time Frame: 90days, 180days, 1year (360days)
    • Time to first rehospitalization
  • Time to first recurrence of AKI
    • Time Frame: 90days, 180days, 1year (360days)
    • Time to first recurrence of AKI
  • Proportion of MACE
    • Time Frame: 30days, 60days, 90days, 180days, 360 days, 3years
    • CVA, AMI, CHF, or cardiac revascularization procedure

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

  • Pregnancy

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Taipei Medical University Shuang Ho Hospital
  • Collaborator
    • National Health Research Institutes, Taiwan
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shuang-Ho Hospital, the EIRAP project, Stop AKI-AKD-CKD continuum in Taiwan: from precision medicine to policy decision (EIRAP study) – Taipei Medical University Shuang Ho Hospital
  • Overall Official(s)
    • Mai-Szu Wu, Study Chair, Shuang Ho Hospital, Taipei Medical University
  • Overall Contact(s)
    • Mai-Szu Wu, MD, +886-2-22490088, maiszuwu@gmail.com

References

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.

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.

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