Acute Renal Failure in the Surgical Intense Care Units - NTUH-SICU-ARF (NSARF) Study
|ClinicalTrials.gov Identifier: NCT00451373|
Recruitment Status : Unknown
Verified January 2007 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : March 23, 2007
Last Update Posted : March 23, 2007
|Condition or disease||Intervention/treatment||Phase|
|Acute Renal Failure Sepsis Postoperative||Device: CVVH and SLED Drug: Vancomycin Drug: Daptomycin Device: FX60, AV600 (dialyzer)||Not Applicable|
Postoperative acute renal failure is a serious complication resulting in a prolonged stay and high mortality. Acute renal failure (ARF) develops in 5 to 30% of patients who undergo surgery, and for all causes, it is associated with mortality rates of 60–90%. Despite advances in supportive care and innovations in renal replacement therapies over the past three decades, the mortality rate for these patients remains high. In the previous analysis of NSARF (National Taiwan University Hospital-Surgical Intense Care Unit- acute renal failure database), the mortality rate of acute renal failure patients in SICU is 66.4%, dialysis dependent rate after ARF is 5% and renal recovery rate is 28.6%. Therefore, the issue concerned is to increase the survival rate and renal recovery rate after acute renal failure.
Perioperative ischemic reperfusion injury may result in acute renal failure (ARF), from which patients can invariably recover. However, there remains a large number of patients whose kidneys fail to recover from ARF, and therefore long-term dialysis is required. The dys-regulation of the inflammatory response in critically ill patients has been implicated as an important mechanism underlying the development of multiple organ system dysfunction, septic shock, and death. Furthermore, an increase in oxidative stress is considered an important pathogenic mechanism in the development of ischemic and toxic renal tubular injury. We hypothesize that extensive immune dys-regulation and increased oxidative stress might be an important factor leading to ARF, and/or associated with their all-cause mortality in critically ill patients.
In this study, we will find out (1) first year, the relationship between cytokine storm and free radical storm with urine output during post-surgical ARF, and the effect of renal replacement therapy on serum cytokines and free radical level (2) 2nd year, the difference outcome between low low-efficient daily dialysis (SLEDD), and low low-efficient daily dialysis-hemofiltration (SLEDD-f), the pharmacokinetics of the SLEDD (3) the 3rd year, we sill established the disease severity score of post-operative ARF patients. (NSARF score) and focus on long-term outcomes for survivors of postoperative ARF. From diagnosis to prognosis, we will incorporate important markers of disease diagnosis, treatment and long term outcome. Finally, we hope to improve the mortality and the life quality of postoperative ARF.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Study Start Date :||July 2006|
|Estimated Study Completion Date :||December 2012|
- the mortality of postoperative acute renal failure
- the cytokine and free radical change of postoperative renal failure
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00451373
|Contact: Wen-Jo Ko, MD, PhDfirstname.lastname@example.org|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Wen-Jo Ko, MD, PhD +886-2-23562082 email@example.com|
|Sub-Investigator: Wen-Jo Ko, MD, PhD|
|Sub-Investigator: Vin-Cent Wu, MD|
|Principal Investigator:||Kwan-Dun Wu, MD, PhD||National Taiwan University Hosptial|
|Study Director:||VinCent Wu, MD||National Taiwan University Hospital|