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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
Information provided by:
Asan Medical Center Identifier:
First received: February 4, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted

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


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00837057

Contact: sangbum hong, md 82-2-3010-3893

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

Responsible Party: sangbum hong, Asan Medical Center Identifier: NCT00837057     History of Changes
Other Study ID Numbers: a085068
Study First Received: February 4, 2009
Last Updated: February 4, 2009

Additional relevant MeSH terms:
Acute Kidney Injury
Shock, Septic
Systemic Inflammatory Response Syndrome
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases processed this record on September 21, 2017