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The Impact of Continuous Renal Replacement Therapy on the Outcomes of Burn Patients With Early Phase of Sepsis (CRRT)

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 December 2011 by Zhiqiang Yuan, Southwest Hospital, China.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01501097
First Posted: December 29, 2011
Last Update Posted: December 30, 2011
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 (Responsible Party):
Zhiqiang Yuan, Southwest Hospital, China
  Purpose
The purpose of this study is to determine if early application of CRRT will result in an improvement of clinical outcomes of burn patients during the early phase of sepsis

Condition Intervention
Burns Sepsis Procedure: Continuous Renal Replacement Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial on the Impact of Early Application of CRRT on the Outcomes of Burn Patients With Early Phase of Sepsis

Resource links provided by NLM:


Further study details as provided by Zhiqiang Yuan, Southwest Hospital, China:

Primary Outcome Measures:
  • Changes in serum cytokine concentrations and clearance [ Time Frame: 96 hours ]
    0, 6, 12 , 24, 48, 96 hours post CRRT


Secondary Outcome Measures:
  • 28 and 90 days survival [ Time Frame: 90 days ]

Estimated Enrollment: 60
Study Start Date: December 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group Procedure: Continuous Renal Replacement Therapy
Patients will be randomized to either arm :early HV-crrt(50ml/kg/h) or Control group
Experimental: early HV-crrt Procedure: Continuous Renal Replacement Therapy
Patients will be randomized to either arm :early HV-crrt(50ml/kg/h) or Control group

Detailed Description:
The impact of Continuous Renal Replacement Therapy (CRRT) on the outcomes of patients with sepsis is controversial, and there is no consensus for the timing and dose of CRRT may improve the outcomes. The purpose of this prospective randomized study is to assess the effect of different CRRT intensity (25ml/kg/h or 50ml/kg/h) on the outcomes of burn patients with early phase of sepsis
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with documented sepsis
  • clinically identified focus of infection associated with at least 2 SIRS -criteria and one or more sepsis-induced organ failures within the 24 hours -prior to inclusion
  • age 18 to 70 years
  • severe burned patients with 50% < TBSA < 85%

Exclusion Criteria:

  • cirrhosis child class C
  • too high APACHE II & SOFA score at admission
  • age over 70 years
  • were presence of a malignant tumor, chronic renal insufficiency (serum creatinine > 133 µmol/L), moribund state, receiving immunosuppressive therapy or receiving any kind of renal replacement therapy before randomization
  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): NCT01501097


Locations
China, Chongqing
Southwest Hospital
Chongqing, Chongqing, China, 400038
Sponsors and Collaborators
Southwest Hospital, China
  More Information

Responsible Party: Zhiqiang Yuan, Associate Professor, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT01501097     History of Changes
Other Study ID Numbers: SWHCBS01
First Submitted: December 20, 2011
First Posted: December 29, 2011
Last Update Posted: December 30, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Sepsis
Toxemia
Burns
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Wounds and Injuries


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