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

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

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

Study Overview

• Status: Unknown
• Conditions: Renal Insufficiency, Chronic; Acute Kidney Injury; Decision Support Systems, Clinical; Acute Kidney Disease
• Intervention / Treatment: Behavioral: Multidisciplinary team (MDT) care and Acute kidney disease (AKD) clinic

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.

• Study Type: Interventional
• Enrollment (Anticipated): 690
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mai-Szu Wu, MD; Phone Number: +886-2-22490088; Email: maiszuwu@gmail.com
• Study Contact Backup: Name: Yu-Wei Chen, MD; Phone Number: 2717 +886-2-22490088; Email: b101091063@tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital
• Collaborators: Taipei Medical University; National Health Research Institutes, Taiwan
• Investigators: Study Chair: Mai-Szu Wu, Shuang Ho Hospital, Taipei Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 29, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; CKD; Acute Kidney Injury; CDS; AKI; Acute Kidney Disease; AKD; Decision Support Systems, Clinical
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: N201905047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No