Clinical trial NCT04145609: Intensified Acute Kidney Disease Care to Reduce Chronic Kidney Disease
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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
name: Taipei Medical University
First posted: 2019-10-30
Enrollment: 690
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Proportion of Major adverse kidney event
timeFrame: 90days
Secondary outcomes:
measure: Mortality
timeFrame: 30days, 60days, 90days, 180days, 360 days, 3years
measure: Chronic dialysis
timeFrame: 90days, 180days, 360 days, 3years
measure: Renal progression
timeFrame: 90days, 180days, 360 days, 3years
measure: Time to MAKE
timeFrame: 90days, 180days, 1year (360days)
measure: Time to death
timeFrame: 90days, 180days, 1year (360days)
measure: Time to chronic dialysis
timeFrame: 90days, 180days, 1year (360days)
measure: Time to renal progression to CKD
timeFrame: 90days, 180days, 1year (360days)
measure: Time to first ER visit
timeFrame: 90days, 180days, 1year (360days)
measure: Time to first rehospitalization
timeFrame: 90days, 180days, 1year (360days)
measure: Time to first recurrence of AKI
timeFrame: 90days, 180days, 1year (360days)
measure: Proportion of MACE
timeFrame: 30days, 60days, 90days, 180days, 360 days, 3years
Other outcomes:
Locations:
Study officials:
affiliation: Shuang Ho Hospital, Taipei Medical University
name: Mai-Szu Wu
role: STUDY_CHAIR
References:
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.
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.