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

February 4, 2009 updated by: Asan Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death from all causes at 28 days after randomisation
Time Frame: 28 day
28 day

Secondary Outcome Measures

Outcome Measure
Time Frame
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
90 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Anticipated)

January 1, 2011

Study Registration Dates

First Submitted

February 4, 2009

First Submitted That Met QC Criteria

February 4, 2009

First Posted (Estimate)

February 5, 2009

Study Record Updates

Last Update Posted (Estimate)

February 5, 2009

Last Update Submitted That Met QC Criteria

February 4, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • a085068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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