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

Primary Purpose

Burns, Sepsis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Continuous Renal Replacement Therapy
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southwest Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

early HV-crrt

Arm Description

Outcomes

Primary Outcome Measures

Changes in serum cytokine concentrations and clearance
0, 6, 12 , 24, 48, 96 hours post CRRT

Secondary Outcome Measures

28 and 90 days survival

Full Information

First Posted
December 20, 2011
Last Updated
December 28, 2011
Sponsor
Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT01501097
Brief Title
The Impact of Continuous Renal Replacement Therapy on the Outcomes of Burn Patients With Early Phase of Sepsis
Acronym
CRRT
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 Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Title
early HV-crrt
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Continuous Renal Replacement Therapy
Intervention Description
Patients will be randomized to either arm :early HV-crrt(50ml/kg/h) or Control group
Primary Outcome Measure Information:
Title
Changes in serum cytokine concentrations and clearance
Description
0, 6, 12 , 24, 48, 96 hours post CRRT
Time Frame
96 hours
Secondary Outcome Measure Information:
Title
28 and 90 days survival
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China

12. IPD Sharing Statement

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

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