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Acute Renal Failure in the Surgical Intense Care Units - NTUH-SICU-ARF (NSARF) Study
This study is currently recruiting participants.
Verified by National Taiwan University Hospital, January 2007
Sponsored by: National Taiwan University Hospital
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00451373
  Purpose

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)

MedlinePlus related topics: Kidney Failure Sepsis
Drug Information available for: Vancomycin Daptomycin Vancomycin hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • the mortality of postoperative acute renal failure

Secondary Outcome Measures:
  • the cytokine and free radical change of postoperative renal failure

Estimated Enrollment: 300
Study Start Date: July 2006
Estimated Study Completion Date: December 2012
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postoperative acute renal failure

Exclusion Criteria:

  • Patients with ECMO or IABP
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451373

Contacts
Contact: Wen-Jo Ko, MD, PhD +886-2-23562082 kdw@ntumc.org

Locations
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            
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Kwan-Dun Wu, MD, PhD National Taiwan University Hosptial
Study Director: VinCent Wu, MD National Taiwan University Hospital
  More Information

Publications:
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

Keywords provided by National Taiwan University Hospital:
ARF, dialysis, cytokine, free radical, major operations

Study placed in the following topic categories:
Daptomycin
Renal Insufficiency
Sepsis
Urologic Diseases
Vancomycin
Renal Insufficiency, Acute
Kidney Diseases
Kidney Failure, Acute
Kidney Failure

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009