Intensified Acute Kidney Disease Care to Reduce Chronic Kidney Disease

Acute Kidney Injury Clinical Trial

— ISACC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04145609
• Other study ID #: N201905047
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2019
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: Mai-Szu Wu, MD
• Phone: +886-2-22490088
• Email: maiszuwu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 690
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Age = 20 yrs

• Severe AKD: Stage 2, Stage 3 and Dialysis-requiring AKD (AKD-D)

Exclusion Criteria:

• Pregnancy

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital	National Health Research Institutes, Taiwan, Taipei Medical University

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Major adverse kidney event	Proportion of MAKE; Renal progression to CKD; Chronic dialysis (any 1 outpatient dialysis after discharge); Death	90days
Secondary	Mortality	Proportion of death	30days, 60days, 90days, 180days, 360 days, 3years
Secondary	Chronic dialysis	Proportion of chronic dialysis	90days, 180days, 360 days, 3years
Secondary	Renal progression	Proportion of renal progression to CKD	90days, 180days, 360 days, 3years
Secondary	Time to MAKE	Time to MAKE	90days, 180days, 1year (360days)
Secondary	Time to death	Time to death	90days, 180days, 1year (360days)
Secondary	Time to chronic dialysis	Time to chronic dialysis	90days, 180days, 1year (360days)
Secondary	Time to renal progression to CKD	Time to renal progression to CKD	90days, 180days, 1year (360days)
Secondary	Time to first ER visit	Time to first ER visit	90days, 180days, 1year (360days)
Secondary	Time to first rehospitalization	Time to first rehospitalization	90days, 180days, 1year (360days)
Secondary	Time to first recurrence of AKI	Time to first recurrence of AKI	90days, 180days, 1year (360days)
Secondary	Proportion of MACE	CVA, AMI, CHF, or cardiac revascularization procedure	30days, 60days, 90days, 180days, 360 days, 3years