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

Primary Purpose

Acute Renal Failure, Sepsis, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
CVVH and SLED
Vancomycin
Daptomycin
FX60, AV600 (dialyzer)
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Renal Failure focused on measuring ARF, dialysis, cytokine, free radical, major operations

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Postoperative acute renal failure

Exclusion Criteria:

  • Patients with ECMO or IABP

Sites / Locations

  • National Taiwan University HospitalRecruiting

Outcomes

Primary Outcome Measures

the mortality of postoperative acute renal failure

Secondary Outcome Measures

the cytokine and free radical change of postoperative renal failure

Full Information

First Posted
March 22, 2007
Last Updated
March 22, 2007
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00451373
Brief Title
Acute Renal Failure in the Surgical Intense Care Units - NTUH-SICU-ARF (NSARF) Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Renal Failure, Sepsis, Postoperative
Keywords
ARF, dialysis, cytokine, free radical, major operations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
CVVH and SLED
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Type
Drug
Intervention Name(s)
Daptomycin
Intervention Type
Device
Intervention Name(s)
FX60, AV600 (dialyzer)
Primary Outcome Measure Information:
Title
the mortality of postoperative acute renal failure
Secondary Outcome Measure Information:
Title
the cytokine and free radical change of postoperative renal failure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postoperative acute renal failure Exclusion Criteria: Patients with ECMO or IABP
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen-Jo Ko, MD, PhD
Phone
+886-2-23562082
Email
kdw@ntumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwan-Dun Wu, MD, PhD
Organizational Affiliation
National Taiwan University Hosptial
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
VinCent Wu, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-Jo Ko, MD, PhD
Phone
+886-2-23562082
Email
kdw@ntumc.org
First Name & Middle Initial & Last Name & Degree
Wen-Jo Ko, MD, PhD
First Name & Middle Initial & Last Name & Degree
Vin-Cent Wu, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
11473662
Citation
Marshall MR, Golper TA, Shaver MJ, Alam MG, Chatoth DK. Sustained low-efficiency dialysis for critically ill patients requiring renal replacement therapy. Kidney Int. 2001 Aug;60(2):777-85. doi: 10.1046/j.1523-1755.2001.060002777.x. Erratum In: Kidney Int 2001 Oct;60(4):1629.
Results Reference
background
PubMed Identifier
10990106
Citation
de Mendonca A, Vincent JL, Suter PM, Moreno R, Dearden NM, Antonelli M, Takala J, Sprung C, Cantraine F. Acute renal failure in the ICU: risk factors and outcome evaluated by the SOFA score. Intensive Care Med. 2000 Jul;26(7):915-21. doi: 10.1007/s001340051281.
Results Reference
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Acute Renal Failure in the Surgical Intense Care Units - NTUH-SICU-ARF (NSARF) Study

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