The Impact of Continuous Renal Replacement Therapy on the... | NCT01501097

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

NCT01501097

Sponsor

Southwest Hospital, China

Status

Unknown status

Last Update Posted

Dec 30, 2011Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Burns
Sepsis

Interventions

Continuous Renal Replacement Therapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Dec 2013Estimated

Completion Date

Not provided

First Submitted Date

Dec 20, 2011

First Submission Date that Met QC Criteria

Dec 25, 2011

First Posted Date

Dec 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2011

Last Update Posted Date

Dec 30, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	No Intervention		Procedure: Continuous Renal Replacement Therapy
early HV-crrt	Experimental		Procedure: Continuous Renal Replacement Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Continuous Renal Replacement Therapy	Procedure	Patients will be randomized to either arm :early HV-crrt(50ml/kg/h) or Control group	Control group early HV-crrt

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
28 and 90 days survival		90 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southwest Hospital		Chongqing	Chongqing Municipality	400038	China

Condition Browse Module

MeSH Terms

ID	Term
D002056	Burns
D018805	Sepsis

Ancestor Terms

ID	Term
D014947	Wounds and Injuries
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000079664	Continuous Renal Replacement Therapy

Ancestor Terms

ID	Term
D017582	Renal Replacement Therapy
D013812	Therapeutics
D005112	Extracorporeal Circulation
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided