2016-05-012024-05-17https://scholars.lib.ntu.edu.tw/handle/123456789/676991隨著現代醫療水準大幅提昇，急性腎損傷患者的發生率仍居高不下，危急患者合併急性腎 損傷之死亡率高達百分之60〜70%，造成處理伴隨急性腎損傷的合併症付出之醫療成本相對龐 大。台灣急性腎損傷及腎病臨床試驗合作聯盟（CAKs)由多位腎病和重症醫學的專家所組成， 在急性腎損傷和重症醫學的領域有豐富的基礎研究、臨床實務以及產學合作經驗，提供國内外 廠商珍貴的急性腎損傷臨床諮詢，而業界開發之新式藥物以及檢驗方法可在本平台下獲得最大 效益之驗證。 CAKs成立的主要任務是；（1)整合國内各醫學中心及醫院的醫療資源，協助國内外產業及 藥廠進行腎臟相關疾病之臨床試驗。（2)建置跨院際急性腎損傷患者的資料庫，以為臨床試驗前 置評估。中心辦公室提供通訊聯絡、資料庫維護和核心研究的協調窗口；核心設施提供臨床研 究者執行標準化的新式生物指標分析，檢測患者包括血液/尿液/腎切片檢體。台灣急性腎損傷及 腎病臨床試驗合作聯盟具備每年招收至少500例急性腎損傷病患者的能力，利用網路建置系統 收集全國性急性透析病人的臨床資料提供分析。103年度執行7個跨國研究計晝，也通過了 4個 跨院倫委會認證。104年？隨著廠商越來越認識CAKs有越來越的的跨國和國内研究計晝目前在 申請進入聯盟試驗。 台灣腎病聯盟包含了分布於台灣四大地理區(北、中、南、東)之30家醫院。此NEP-AKI-D study 將收納這些醫院中，於四個取樣月（October 2014, along with January, April, and July 2015)中，在 加護病房内因為急性腎損傷而接受透析治療之重症患者。收集的資料包含患者基本料、生化 資料、透析治療之相關資料、以及患者之預後狀態。本研究將觀察之標的為：住院中死亡率、 透析依賴率、以及出院後90天内之再住院率。.CAKs的目標是推動有治療潛力的急性腎損傷 臨床試驗，加速治療方法發展，降低急性腎損傷的發生率，減緩併發慢性腎病、末期腎病的機 率，務求協助國人延長壽命、追求良好的生活品質。The incidence rate of acute kidney injury (AKI) in hospitalized patients is increasing, and the number of deaths associated with dialysis-requiring AKI has more than doubled. Through strategies to lower the incidence of AKI and clarify the causal nature of the (acute kidney injury to chronic kidney disease) AKI-CKD relationship, further light will be shed on lowering the CKD burden by nipping it in the bud. CAKs will build a platform on which we share the clinical data and exchange state-of-the-art research information. Currently, the incidence rate of dialysis-requiring AKI is higher than that of end-stage renal disease (ESRD), and its annual growth rate is as high as 10% in the United States. To promote Taiwan Consortium of Acute Kidney Injury and Renal Diseases (CAKs) as the leading kidney diseases of the clinical trial group in Asia-Pacific by establishing a cohesive group of kidney clinical trial sites that conduct uniform standard-of-care and high quality clinical trial performance in renal diseases and provide credible and reliable data. The CAKs includes 30 hospitals which distribute widely through the four geographical regions (north, middle, south, and east) of Taiwan. The NEP-AKI-D study enrolls intensive care unit-based AKI patients who receive dialysis in the four seasonal sampled months (October 2014, along with January, April, and July 2015). The collected data include demographic information, pertaining laboratory results, dialysis settings, and patient outcomes. The outcomes of interest are in-hospital mortality, dialysis-dependency, and readmission rate within 90 days after discharge. The participating investigators of CAKs are specialists of kidney medicine who have experience in conducting bench and clinical studies of kidney diasese. The key missions of the CAKs will be to assist the design and conduct of multi-center investigator-initiated, industry or international research groups) clinical trials, as well as the establishment of biospecimen database of patients with kidney disease. The Central office will provide the window of communication, database auditing and the improving quality of specimens, and core study coordination. The core facility of CAKs will provide Standardized analysis for novel AKI biomarkers. Participating subjects need to sign the informed consent for clinical data, PBMC/plasma/serum/ specimens from kidney biopsy. In the initial first year, we have conducted 7 international clinical studies, applied and finished 4full ethical reviews by the institutional review board of NRPB in 2014. How about 2015? This year, we will work on 1. Improved AKI using “adsorbent” Clinical prospective multicenter randomized controlled trial (RCT) study.2. The Effect of Endotoxin Adsorbed Hemoperfusion on the Microcirculation in Patients with Severe Sepsis and Septic Shock. 3. Validation the device from Advanced Circuits Research Laboratory 4. The effects of medium-chain triglyceride on nutritional markers and quality of life in maintenance hemodialysis patients By estimation, the consortium has the ability to enroll patients with kidney disease and record the acute dialysis during intensive units. Core clinical information will be collected using a web based information system for future analysis. The ultimate goal for CAKs is to enable clinical trials of potential therapies for kidney diseases and speed the development of treatments that will improve the severity of end stage renal disease and mortality for patients with kidney diseases.急性腎損傷臨床試驗多中心臨床試驗跨國合作Index wordsAcute kidney injurykidney diseaseclinical studymulticenter randomized controlled trial