Intensified Acute Kidney Disease Care to Reduce Chronic Kidney Disease

NCT04145609 | Unknown

• 1 other identifier: N201905047
• Study Type: interventional
• Target: 690
• Locations: 0 countries
• Sites: N/A

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

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

Outcome Measures

Primary Outcomes (1)

• Proportion of Major adverse kidney event

  Proportion of MAKE * Renal progression to CKD * Chronic dialysis (any 1 outpatient dialysis after discharge) * Death

  90days

Secondary Outcomes (11)

• Mortality

  30days, 60days, 90days, 180days, 360 days, 3years

• Chronic dialysis

  90days, 180days, 360 days, 3years

• Renal progression

  90days, 180days, 360 days, 3years

• Time to MAKE

  90days, 180days, 1year (360days)

• Time to death

  90days, 180days, 1year (360days)

Study Arms (2)

Intensified care

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

Multidisciplinary team (MDT) care and Acute kidney disease (AKD) clinic BEHAVIORAL

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

Intensified care

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead
• National Health Research Institutes, Taiwan: collaborator
• Taipei Medical University: collaborator

Related Publications (2)

• 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.

  PMID: 28239173 BACKGROUND

• 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.

  PMID: 30473140 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Interventions

Ambulatory Care Facilities

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Mai-Szu Wu

  Shuang Ho Hospital, Taipei Medical University

  STUDY CHAIR

Central Study Contacts

Mai-Szu Wu, MD

CONTACT

+886-2-22490088; maiszuwu@gmail.com

Yu-Wei Chen, MD

CONTACT

+886-2-22490088; b101091063@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stop AKI-AKD-CKD continuum in Taiwan: from precision medicine to policy decision (EIRAP study)

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: October 30, 2019

Record last verified: 2019-10