Acute Kidney InjuryISACCNCT04145609
Intensified Acute Kidney Disease Care to Reduce Chronic Kidney Disease
A study testing Multidisciplinary team (MDT) care and Acute kidney disease (AKD) clinic in people with Acute Kidney Injury and Renal Insufficiency, Chronic, run by Taipei Medical University Shuang Ho Hospital.
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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Kidney Injury, Renal Insufficiency, Chronic, Acute Kidney Disease
- What is being tested?
- Multidisciplinary team (MDT) care and Acute kidney disease (AKD) clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 690 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 20 yrs
- Severe AKD: Stage 2, Stage 3 and Dialysis-requiring AKD (AKD-D)
Who cannot join
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Acute Kidney Injury, Renal Insufficiency, Chronic, Acute Kidney Disease, Decision Support Systems, Clinical
- Being tested
- Multidisciplinary team (MDT) care and Acute kidney disease (AKD) clinic
- Keywords
- Acute Kidney Injury, Acute Kidney Disease, Chronic Kidney Disease, AKI, AKD, CKD, Decision Support Systems, Clinical, CDS
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary team (MDT) care and Acute kidney disease (AKD) clinicBehavioural
Multidisciplinary team (MDT) care: NPDS care model Acute kidney disease (AKD) clinic: layered approach
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Major adverse kidney event
Proportion of MAKE
- Renal progression to CKD
- Chronic dialysis (any 1 outpatient dialysis after discharge)
- Death
Measured: 90days
Secondary outcomes (11)
Mortality
Proportion of death
Measured: 30days, 60days, 90days, 180days, 360 days, 3years
Chronic dialysis
Proportion of chronic dialysis
Measured: 90days, 180days, 360 days, 3years
Renal progression
Proportion of renal progression to CKD
Measured: 90days, 180days, 360 days, 3years
Time to MAKE
Time to MAKE
Measured: 90days, 180days, 1year (360days)
Time to death
Time to death
Measured: 90days, 180days, 1year (360days)
Time to chronic dialysis
Time to chronic dialysis
Measured: 90days, 180days, 1year (360days)
Time to renal progression to CKD
Time to renal progression to CKD
Measured: 90days, 180days, 1year (360days)
Time to first ER visit
Time to first ER visit
Measured: 90days, 180days, 1year (360days)
Time to first rehospitalization
Time to first rehospitalization
Measured: 90days, 180days, 1year (360days)
Time to first recurrence of AKI
Time to first recurrence of AKI
Measured: 90days, 180days, 1year (360days)
Proportion of MACE
CVA, AMI, CHF, or cardiac revascularization procedure
Measured: 30days, 60days, 90days, 180days, 360 days, 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 690 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan, Taipei Medical University
- Responsible party
- Principal investigator, Shuang-Ho Hospital, the EIRAP project, Taipei Medical University Shuang Ho Hospital
- Investigators
- Mai-Szu Wu, Study chair, Shuang Ho Hospital, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145609
- Sponsor's protocol ID
- N201905047
- Acronym
- ISACC
- Status last verified
- Oct 2019
- First submitted
- 28 Oct 2019
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
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 28239173See 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04145609
- Acronym / sponsor ID
- ISACC / N201905047
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 690 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan, Taipei Medical University
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensified care | Experimental | Behavioral: Multidisciplinary team (MDT) care and Acute kidney disease (AKD) clinicExperimental: 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. |
| 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 20 yrs
- Severe AKD: Stage 2, Stage 3 and Dialysis-requiring AKD (AKD-D)
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary team (MDT) care and Acute kidney disease (AKD) clinicMultidisciplinary team (MDT) care: NPDS care model Acute kidney disease (AKD) clinic: layered approach | Behavioural | Intensified care |
Primary outcome
Proportion of Major adverse kidney event
Time frame: 90days
Proportion of MAKE * Renal progression to CKD * Chronic dialysis (any 1 outpatient dialysis after discharge) * Death
11 secondary outcomes
Mortality
Time frame: 30days, 60days, 90days, 180days, 360 days, 3years
Chronic dialysis
Time frame: 90days, 180days, 360 days, 3years
Renal progression
Time frame: 90days, 180days, 360 days, 3years
Time to MAKE
Time frame: 90days, 180days, 1year (360days)
Time to death
Time frame: 90days, 180days, 1year (360days)
Time to chronic dialysis
Time frame: 90days, 180days, 1year (360days)
Time to renal progression to CKD
Time frame: 90days, 180days, 1year (360days)
Time to first ER visit
Time frame: 90days, 180days, 1year (360days)
Time to first rehospitalization
Time frame: 90days, 180days, 1year (360days)
Time to first recurrence of AKI
Time frame: 90days, 180days, 1year (360days)
Proportion of MACE
Time frame: 30days, 60days, 90days, 180days, 360 days, 3years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Background: PubMed 28239173Chawla 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.
- Background: PubMed 30473140See 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.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mai-Szu Wu study chair
Shuang Ho Hospital, Taipei Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary team (MDT) care and Acute kidney disease (AKD) clinic in people with Acute Kidney Injury and Renal Insufficiency, Chronic, run by Taipei Medical University Shuang Ho Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mai-Szu Wu, MD (+886-2-22490088, maiszuwu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Major adverse kidney event (time frame: 90days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04145609, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.