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Status unknownNCT04145609ISACCUpdated Oct 30, 2019

Intensified Acute Kidney Disease Care to Reduce Chronic Kidney Disease

An interventional study of Multidisciplinary team (MDT) care and Acute kidney disease (AKD) clinic in Acute Kidney Injury, Renal Insufficiency, Chronic and Acute Kidney Disease, sponsored by Taipei Medical University Shuang Ho Hospital. Status unknown. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-10-30.

Sponsored by Taipei Medical University Shuang Ho Hospital · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
690
Allocation
Randomized
Ages
20 Years and older
Sex
All
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Study 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

Read the 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.

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Conditions studied

  • 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
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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 690 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Taipei Medical University Shuang Ho Hospital is the lead sponsor of 100 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
690 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralMultidisciplinary team (MDT) care and Acute kidney disease (AKD) clinic

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

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What researchers measure

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

    Time frame: 90days

Secondary outcomes

  1. Mortality

    Proportion of death

    Time frame: 30days, 60days, 90days, 180days, 360 days, 3years

  2. Chronic dialysis

    Proportion of chronic dialysis

    Time frame: 90days, 180days, 360 days, 3years

  3. Renal progression

    Proportion of renal progression to CKD

    Time frame: 90days, 180days, 360 days, 3years

  4. Time to MAKE

    Time to MAKE

    Time frame: 90days, 180days, 1year (360days)

  5. Time to death

    Time to death

    Time frame: 90days, 180days, 1year (360days)

  6. Time to chronic dialysis

    Time to chronic dialysis

    Time frame: 90days, 180days, 1year (360days)

  7. Time to renal progression to CKD

    Time to renal progression to CKD

    Time frame: 90days, 180days, 1year (360days)

  8. Time to first ER visit

    Time to first ER visit

    Time frame: 90days, 180days, 1year (360days)

  9. Time to first rehospitalization

    Time to first rehospitalization

    Time frame: 90days, 180days, 1year (360days)

  10. Time to first recurrence of AKI

    Time to first recurrence of AKI

    Time frame: 90days, 180days, 1year (360days)

  11. Proportion of MACE

    CVA, AMI, CHF, or cardiac revascularization procedure

    Time frame: 30days, 60days, 90days, 180days, 360 days, 3years

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 28239173 ↗
  • 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. PubMed 30473140 ↗

Individual participant data

Plan to share: Undecided — Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04145609
Lead sponsor
Taipei Medical University Shuang Ho Hospital
Collaborators
National Health Research Institutes, Taiwan, Taipei Medical University
Responsible party
Shuang-Ho Hospital, the EIRAP project (Stop AKI-AKD-CKD continuum in Taiwan: from precision medicine to policy decision (EIRAP study), Taipei Medical University Shuang Ho Hospital) — Principal investigator
First posted
Oct 30, 2019
Start date
Jan 1, 2020 (estimated)
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Oct 30, 2019

Study contacts

Mai-Szu Wu, MD
Contact
maiszuwu@gmail.com
+886-2-22490088
Yu-Wei Chen, MD
Contact
b101091063@tmu.edu.tw
+886-2-22490088 ext. 2717
Mai-Szu Wu
study chair · Shuang Ho Hospital, Taipei Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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