Back to resultsEarly Continuous Renal Replacement Therapies (CRRT) in Patients With Severe Sepsis or Septic Shock With Acute Kidney Injury
Primary Purpose
Severe Sepsis, Septic Shock, Acute Kidney Injury
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
crrt
Sponsored by
About this trial
This is an interventional treatment trial for Severe Sepsis
Eligibility Criteria
Inclusion Criteria:
- Septic shock (Bone criteria) for less than 14D
- RIFLE criteria : Injury or Failure or nearly anuria more than 2hr
- Age over 18 years
- Written informed consent by next of kin.
Exclusion Criteria:
- Cirrhosis child class C
- CRF or ESRD
- Too high APACHE II & SOFA score at admission
- Age over 80 years
- Life expectancy less than 3 months (metastatic cancer - hepatoma, lung ca.)
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
early crrt, late crrt
Arm Description
Outcomes
Primary Outcome Measures
Death from all causes at 28 days after randomisation
Secondary Outcome Measures
Death within the in the intensive care unit. Death within 90 days of randomisation. Death prior to hospital discharge. Length of ICU stay. The need for and duration of other organ support
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00837057
Brief Title
Early Continuous Renal Replacement Therapies (CRRT) in Patients With Severe Sepsis or Septic Shock With Acute Kidney Injury
Official Title
A Randomized Controlled Multi-Center Trial of the Early Application of CRRT in Patients With Severe Sepsis or Septic Shock
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Severe sepsis or septic shock with acute kidney injury shows high mortality in intensive care unit. A few studies have shown CRRT relating the clinical improvement seems to be related to the early initiation of therapy. But there is no consensus for proper time of CRRT may improve the prognosis.
The study is a prospective randomized one center trial comparing two treatments in patients suffering from septic shock complicated with acute renal failure admitted to ICU, treated either early by CRRT (35 ml/kg/h) or by conventional RRT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis, Septic Shock, Acute Kidney Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
early crrt, late crrt
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
crrt
Other Intervention Name(s)
renal replacement therapy, timing
Intervention Description
early CRRT (35 ml/kg/h)& acute kidney injury or failure or nearly anuria more than 2hr or late conventional dialysis indication
Primary Outcome Measure Information:
Title
Death from all causes at 28 days after randomisation
Time Frame
28 day
Secondary Outcome Measure Information:
Title
Death within the in the intensive care unit. Death within 90 days of randomisation. Death prior to hospital discharge. Length of ICU stay. The need for and duration of other organ support
Time Frame
90 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Septic shock (Bone criteria) for less than 14D
RIFLE criteria : Injury or Failure or nearly anuria more than 2hr
Age over 18 years
Written informed consent by next of kin.
Exclusion Criteria:
Cirrhosis child class C
CRF or ESRD
Too high APACHE II & SOFA score at admission
Age over 80 years
Life expectancy less than 3 months (metastatic cancer - hepatoma, lung ca.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sangbum hong, md
Phone
82-2-3010-3893
Email
sbhong@amc.seoul.kr
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sangbum hong, md
Phone
82-2-3010-3893
Email
sbhong@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
sangbum hong, md
12. IPD Sharing Statement
Learn more about this trial
Early Continuous Renal Replacement Therapies (CRRT) in Patients With Severe Sepsis or Septic Shock With Acute Kidney Injury
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