Intensified Acute Kidney Disease Care to Reduce Chronic Kidney Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Strategies to Stop Acute Kidney Injury (AKI)-Acute Kidney Disease (AKD) -Chronic Kidney Disease (CKD) Continuum - Policy The Intensified AKD Care to Reduce CKD

Conditions
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Acute Kidney Injury, Renal Insufficiency, Chronic, Acute Kidney Disease, Decision Support Systems, Clinical

Intervention / Treatment
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* Behavioral: Multidisciplinary team (MDT) care and Acute kidney disease (AKD) clinic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 20 yrs Severe AKD: Stage 2, Stage 3 and Dialysis-requiring AKD (AKD-D) Exclusion Criteria: Pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensified care<br>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. | Behavioral: Multidisciplinary team (MDT) care and Acute kidney disease (AKD) clinic<br>* Multidisciplinary team (MDT) care: NPDS care model Acute kidney disease (AKD) clinic: layered approach<br>|
| No Intervention: Usual care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Major adverse kidney event | Proportion of MAKE Renal progression to CKD Chronic dialysis (any 1 outpatient dialysis after discharge) Death | 90days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Kidney Injury, Acute Kidney Disease, Chronic Kidney Disease, AKI, AKD, CKD, Decision Support Systems, Clinical, CDS