Intensified Acute Kidney Disease Care to Reduce Chronic Kidney Disease

NCT ID: NCT04145609

Last Updated: 2019-10-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 690 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2021-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: collaborator

Taipei Medical University

OTHER

Sponsor Role: collaborator

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shuang-Ho Hospital, the EIRAP project

Stop AKI-AKD-CKD continuum in Taiwan: from precision medicine to policy decision (EIRAP study)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mai-Szu Wu

Role: STUDY_CHAIR

Shuang Ho Hospital, Taipei Medical University

Central Contacts

Mai-Szu Wu, MD

Role: CONTACT

maiszuwu@gmail.com

+886-2-22490088

Yu-Wei Chen, MD

Role: CONTACT

b101091063@tmu.edu.tw

+886-2-22490088 ext. 2717

References

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.

Reference Type: BACKGROUND

PMID: 28239173 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30473140 (View on PubMed)

Other Identifiers

N201905047

Identifier Type: -

Identifier Source: org_study_id