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Acute Renal Failure in the Surgical Intense Care Units - NTUH-SICU-ARF (NSARF) Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Information provided by:
National Taiwan University Hospital Identifier:
First received: March 22, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
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: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment

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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Postoperative acute renal failure

Exclusion Criteria:

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

Contact: Wen-Jo Ko, MD, PhD +886-2-23562082

National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Wen-Jo Ko, MD, PhD    +886-2-23562082   
Sub-Investigator: Wen-Jo Ko, MD, PhD         
Sub-Investigator: Vin-Cent Wu, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Kwan-Dun Wu, MD, PhD National Taiwan University Hosptial
Study Director: VinCent Wu, MD National Taiwan University Hospital
  More Information

Publications: Identifier: NCT00451373     History of Changes
Other Study ID Numbers: 9561709099
Study First Received: March 22, 2007
Last Updated: March 22, 2007

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

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents processed this record on August 17, 2017