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 because the information has not been verified recently.
Verified January 2009 by Asan Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00837057
First received: February 4, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: sangbum hong, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00837057     History of Changes
Other Study ID Numbers: a085068
Study First Received: February 4, 2009
Last Updated: February 4, 2009
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014