A Randomized Controlled Multi-Center Trial of the Early Application of CRRT in Patients With Severe Sepsis or Septic Shock

Asan Medical Center1 site in 1 country60 target enrollmentFebruary 2009

ConditionsSevere Sepsis Septic Shock Acute Kidney Injury

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Severe Sepsis
Sponsor: Asan Medical Center
Enrollment: 60
Locations: 1
Primary Endpoint: Death from all causes at 28 days after randomisation
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

January 2011

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Asan Medical Center

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.)

Outcomes

Primary Outcomes

Death from all causes at 28 days after randomisation

Time Frame: 28 day

Secondary Outcomes

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)