Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Taiwan University Hospital |
---|---|
Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00451373 |
We examine the prognosis and etiology of postoperative acute renal failure
Condition | Intervention |
---|---|
Acute Renal Failure Sepsis Postoperative |
Device: CVVH and SLED Drug: Vancomycin Drug: Daptomycin Device: FX60, AV600 (dialyzer) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 300 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | December 2012 |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Wen-Jo Ko, MD, PhD | +886-2-23562082 | kdw@ntumc.org |
Taiwan | |
National Taiwan University Hospital | Recruiting |
Taipei, Taiwan, 100 | |
Contact: Wen-Jo Ko, MD, PhD +886-2-23562082 kdw@ntumc.org | |
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 |
Study ID Numbers: | 9561709099, 31MD03 |
Study First Received: | March 22, 2007 |
Last Updated: | March 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00451373 |
Health Authority: | Taiwan: Department of Health; United States: Food and Drug Administration |
ARF, dialysis, cytokine, free radical, major operations |
Daptomycin Renal Insufficiency Sepsis Urologic Diseases Vancomycin |
Renal Insufficiency, Acute Kidney Diseases Kidney Failure, Acute Kidney Failure |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Pharmacologic Actions |