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Clinical Trial Summary

The incidence rate of acute kidney injury (AKI) in hospitalized patients is increasing, and the mortality associated with dialysis-requiring AKI remains as high as 60-70%. In these patients, AKI results are increased in-hospital and post-hospitalization medical resource utilization. To improve AKI-associated morbidity and mortality, Taiwan Consortium of Acute Kidney Injury and Renal Diseases (CAKS, TCTC) as the leading clinical trial group of kidney diseases in Asia-Pacific will establish an anonymous nationwide AKI database to explore the epidemiology, risk factors and prognosis of AKI in Taiwan. The demographic and clinical information of AKI stage 2, 3 or weaning from dialysis requiring AKI patients (AKI-D), will be prospectively collected for further analysis. In this double two-by-two factorial design, upon the identification of AKI stage 2, 3 or weaning from AKI-D at index out patients clinics, enrollees who are randomly assigned to slow kidney function progression first by randomization to add Angiotensin-Converting Enzyme Inhibitors (ACE-I)/Angiotensin II Receptor Blocker (ARB), or by randomization to multidisciplinary care. Patients will be followed up at least 6 months to evaluate kidney function and the predictability of developing chronic kidney disease, end stage renal disease, major cardiovascular events and mortality.


Clinical Trial Description

Acute kidney injury is an emerging syndrome in the past 10 years. Among hospital diagnosed kidney disease, acute renal disease outnumbered chronic kidney disease (CKD) since 2005, and the incidence is still climbing. Patients who were diagnosed with AKI bear a substantial risk for adverse outcomes, including premature death, increased morbidity, prolonged hospitalization, and increased medical costs. A variety of factors may predispose a patient to AKI, including poor pre-morbid kidney reserve, conditions leading to hemodynamic instability, or increased complexity of concurrent medications. With the advance of modern medical diagnosis and treatment modalities, the incidence and prevalence of AKI syndrome gradually increase over the past years. The KDIGO Guideline for AKI recommended that we should diagnose AKI if a given patient has a 6 hour urine amount less than 0.5ml/kg/hr or a serum creatinine elevates more than 0.3mg/dL or 1.5 times greater than baselines. Epidemiology data on hospitalized patients indeed disclosed high risk for adverse events using this classification system and its analogues. However, besides diagnosis, we do not have a useful tool to treat or to help improve patient outcomes Acute kidney injury (AKI) is a common complication that affects nearly 5% of hospitalized patients and 40%-70% of patients in the intensive care unit. AKI requiring dialysis (AKI-D), the most severe type of AKI, is associated with the highest proportion of morbidity and mortality. AKI is associated with a risk of end-stage renal disease (ESRD) that is 13 times as high as the risk among patients without AKI, and the risk of ESRD is 40 times as high if the patients have both AKI and pre-existing chronic kidney disease (CKD). Since AKI is recognized as a risk factor for the development of ESRD, it is crucial to have appropriate protection strategies for the avoidance of further target organ damage and associated mortality in the critical phases of the acute kidney disease (AKD). Several studies have validated the hypothesis proposed by Guyton that the kidneys have a crucial role in affecting the chronic level of blood pressure (BP). Furthermore, AKI during hospitalization was an independent risk factor for subsequent development of BP elevation. BP level is related to the risk of cardiovascular disease and death, which makes the elevated BP as a leading risk factor for global health. However, it is still a missing puzzle piece in the timely pharmacologic treatment and long-term target organ protection of AKD patients. By retrospective analysis of the large FROG ICU database, including 1551 ICU survivors, of which 611 had AKI during their ICU stay, the authors could demonstrate reduced 1-year mortality in the cohort who had AKI and who were prescribed ACEIs/ARBs. To address the issue of the 'black hole' between AKI and CKD, the Kidney Disease: Improving Global Outcomes (KDIGO) AKI Workgroup propose the concept of acute kidney disease (AKD). AKD, defined as a glomerular filtration rate (GFR) <60 ml/min/1.73 m2 or evidence of structural kidney damage for <3 months, provides an operationally integrated bridge between AKI and CKD. The AKD concept, which incorporates the concept of partial renal recovery, might also help raise awareness and engender the necessary clinical mechanisms to follow AKI survivors for progression to CKD, which has been recently highlighted as a missed opportunity for adequate transitions of care. Also, a panel of gut microbiota and biomarkers will also be determined. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05064904
Study type Interventional
Source National Taiwan University Hospital
Contact Vincent Wu, doctor
Phone 886-937-223-278
Email [email protected]
Status Recruiting
Phase N/A
Start date February 15, 2019
Completion date February 15, 2024

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