NCT01501097

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

December 30, 2011

Status Verified

December 1, 2011

Enrollment Period

2 years

First QC Date

December 20, 2011

Last Update Submit

December 28, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in serum cytokine concentrations and clearance

    0, 6, 12 , 24, 48, 96 hours post CRRT

    96 hours

Secondary Outcomes (1)

  • 28 and 90 days survival

    90 days

Study Arms (2)

Control group

NO INTERVENTION
Procedure: Continuous Renal Replacement Therapy

early HV-crrt

EXPERIMENTAL
Procedure: Continuous Renal Replacement Therapy

Interventions

Patients will be randomized to either arm :early HV-crrt(50ml/kg/h) or Control group

Control groupearly HV-crrt

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with documented sepsis
  • age 18 to 70 years
  • severe burned patients with 50% \< TBSA \< 85%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

Location

MeSH Terms

Conditions

BurnsSepsis

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Wounds and InjuriesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 20, 2011

First Posted

December 29, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2013

Last Updated

December 30, 2011

Record last verified: 2011-12

Locations