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

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ClinicalTrials.gov Identifier: NCT01501097
Recruitment Status : Unknown
Verified December 2011 by Zhiqiang Yuan, Southwest Hospital, China.
Recruitment status was:  Active, not recruiting
First Posted : December 29, 2011
Last Update Posted : December 30, 2011
Sponsor:
Information provided by (Responsible Party):
Zhiqiang Yuan, Southwest Hospital, China

Brief Summary:
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 or disease Intervention/treatment
Burns Sepsis Procedure: Continuous Renal Replacement Therapy

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : December 2011
Estimated Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Sepsis
U.S. FDA Resources

Arm Intervention/treatment
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



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


Secondary Outcome Measures :
  1. 28 and 90 days survival [ Time Frame: 90 days ]


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

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

Responsible Party: Zhiqiang Yuan, Associate Professor, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT01501097     History of Changes
Other Study ID Numbers: SWHCBS01
First Posted: December 29, 2011    Key Record Dates
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