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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
National Taiwan University Hospital

Brief Summary:
We examine the prognosis and etiology of postoperative acute renal failure

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

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Study Start Date : July 2006
Estimated Study Completion Date : December 2012

Primary Outcome Measures :
  1. the mortality of postoperative acute renal failure

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

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

Inclusion Criteria:

  • Postoperative acute renal failure

Exclusion Criteria:

  • Patients with ECMO or IABP

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications: Identifier: NCT00451373     History of Changes
Other Study ID Numbers: 9561709099
First Posted: March 23, 2007    Key Record Dates
Last Update Posted: March 23, 2007
Last Verified: January 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