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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Zhiqiang Yuan, Southwest Hospital, China
ClinicalTrials.gov Identifier:
NCT01501097
First received: December 20, 2011
Last updated: December 28, 2011
Last verified: December 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

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

Further study details as provided by Southwest Hospital, China:

Primary Outcome Measures:
  • Changes in serum cytokine concentrations and clearance [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
    0, 6, 12 , 24, 48, 96 hours post CRRT


Secondary Outcome Measures:
  • 28 and 90 days survival [ Time Frame: 90 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501097

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

No publications provided

Responsible Party: Zhiqiang Yuan, Associate Professor, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT01501097     History of Changes
Other Study ID Numbers: SWHCBS01
Study First Received: December 20, 2011
Last Updated: December 28, 2011
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013