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Intensified Acute Kidney Disease Care to Reduce Chronic Kidney Disease

Not Applicable
Conditions
Acute Kidney Disease
Acute Kidney Injury
Renal Insufficiency, Chronic
Decision Support Systems, Clinical
Interventions
Behavioral: Multidisciplinary team (MDT) care and Acute kidney disease (AKD) clinic
Registration Number
NCT04145609
Lead Sponsor
Taipei Medical University Shuang Ho Hospital
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
690
Inclusion Criteria
  • Age ≥ 20 yrs
  • Severe AKD: Stage 2, Stage 3 and Dialysis-requiring AKD (AKD-D)
Exclusion Criteria
  • Pregnancy

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intensified careMultidisciplinary team (MDT) care and Acute kidney disease (AKD) clinicExperimental: 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.
Primary Outcome Measures
NameTimeMethod
Proportion of Major adverse kidney event90days

Proportion of MAKE

* Renal progression to CKD

* Chronic dialysis (any 1 outpatient dialysis after discharge)

* Death

Secondary Outcome Measures
NameTimeMethod
Mortality30days, 60days, 90days, 180days, 360 days, 3years

Proportion of death

Proportion of MACE30days, 60days, 90days, 180days, 360 days, 3years

CVA, AMI, CHF, or cardiac revascularization procedure

Time to first ER visit90days, 180days, 1year (360days)

Time to first ER visit

Renal progression90days, 180days, 360 days, 3years

Proportion of renal progression to CKD

Time to first recurrence of AKI90days, 180days, 1year (360days)

Time to first recurrence of AKI

Time to MAKE90days, 180days, 1year (360days)

Time to MAKE

Time to death90days, 180days, 1year (360days)

Time to death

Time to chronic dialysis90days, 180days, 1year (360days)

Time to chronic dialysis

Time to renal progression to CKD90days, 180days, 1year (360days)

Time to renal progression to CKD

Time to first rehospitalization90days, 180days, 1year (360days)

Time to first rehospitalization

Chronic dialysis90days, 180days, 360 days, 3years

Proportion of chronic dialysis

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