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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Asan Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00837057
First Posted: February 5, 2009
Last Update Posted: February 5, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Asan Medical Center
  Purpose

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 Intervention Phase
Severe Sepsis Septic Shock Acute Kidney Injury Procedure: crrt Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Death from all causes at 28 days after randomisation [ Time Frame: 28 day ]

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 [ Time Frame: 90 day ]

Estimated Enrollment: 60
Study Start Date: February 2009
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: renal replacement therapy, timing

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837057


Contacts
Contact: sangbum hong, md 82-2-3010-3893 sbhong@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: sangbum hong, md    82-2-3010-3893    sbhong@amc.seoul.kr   
Principal Investigator: sangbum hong, md         
Sponsors and Collaborators
Asan Medical Center
  More Information

Responsible Party: sangbum hong, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00837057     History of Changes
Other Study ID Numbers: a085068
First Submitted: February 4, 2009
First Posted: February 5, 2009
Last Update Posted: February 5, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock
Acute Kidney Injury
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases