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Early Continuous Renal Replacement Therapies (CRRT) in Patients With Severe Sepsis or Septic Shock With Acute Kidney Injury

Sponsor
Asan Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00837057
Collaborator
(none)
60
Enrollment
1
Location
1
Arm

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: crrt
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Multi-Center Trial of the Early Application of CRRT in Patients With Severe Sepsis or Septic Shock
Study Start Date :
Feb 1, 2009
Anticipated Primary Completion Date :
Jan 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Other: early crrt, late crrt

Procedure: crrt
early CRRT (35 ml/kg/h)& acute kidney injury or failure or nearly anuria more than 2hr or late conventional dialysis indication
Other Names:
  • renal replacement therapy, timing

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Death from all causes at 28 days after randomisation [28 day]

    Secondary Outcome Measures

    1. 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 [90 day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Asan Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00837057
    Other Study ID Numbers:
    • a085068
    First Posted:
    Feb 5, 2009
    Last Update Posted:
    Feb 5, 2009
    Last Verified:
    Jan 1, 2009
    Additional relevant MeSH terms:
    Sepsis
    Toxemia
    Shock, Septic
    Acute Kidney Injury
    Shock

    Study Results

    No Results Posted as of Feb 5, 2009