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

Sepsis Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01501097
• Other study ID #: SWHCBS01
• Status: Active, not recruiting
• Phase: N/A
• First received: December 20, 2011
• Last updated: December 28, 2011
• Start date: December 2011

Study information

• Verified date: December 2011
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Sepsis

Intervention

Procedure:
• Continuous Renal Replacement Therapy
Patients will be randomized to either arm :early HV-crrt(50ml/kg/h) or Control group

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in serum cytokine concentrations and clearance	0, 6, 12 , 24, 48, 96 hours post CRRT	96 hours	No
Secondary	28 and 90 days survival		90 days	No