Effect of the Intensity of Continuous Renal Replacement T... | NCT01251081

Studies
Effect of the Intensity of Continuous Renal Replacement Therapy

NCT01251081

Sponsor

Zhejiang University

Status

Completed

Last Update Posted

Dec 1, 2010Estimated

Enrollment

280Actual

Phase

Not Applicable

Conditions

Optimal Intensity of Renal Replacement Therapy on Sepsis Patients

Interventions

extra high volume hemofiltration
high volume hemofiltration

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

Jan 2004

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Aug 2009Actual

Completion Date

Jun 2010Actual

First Submitted Date

Nov 30, 2010

First Submission Date that Met QC Criteria

Nov 30, 2010

First Posted Date

Dec 1, 2010Estimated

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

Nov 30, 2010

Last Update Posted Date

Dec 1, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

In patients with sepsis and AKI, increasing the intensity of renal replacement therapy from 50 mL/kg/h (HVHF) to 85 mL/kg/h (EHVHF)will increase the survival at 28 days and 90 days.

Detailed Description

Not provided

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

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

280Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
extra high volume hemofiltration	Experimental	extra high volume hemofiltration (85 mL/kg/h, EHVHF)	Other: extra high volume hemofiltration
high volume hemofiltration	Sham Comparator	high volume hemofiltration (50 mL/kg/h, HVHF)	Other: high volume hemofiltration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
extra high volume hemofiltration	Other	extra high volume hemofiltration (85 mL/kg/h, EHVHF)	extra high volume hemofiltration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
90 days survival	The primary study outcome was death from any cause within 90 days. Results were analyzed by Kaplan-Meier survival curves

Secondary Outcomes

Measure	Description	Time Frame
length of stay in the ICU and hospital	Secondary outcomes were length of stay in the ICU and hospital and renal outcome of survivors at 90 days after randomization.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

met at least one of the following criteria: oliguria (urine output less than 100 mL in a 6 h period and unresponsive to fluid resuscitation), serum potassium concentration more than 6.5 mmol/L, severe acidemia (pH < 7.2), serum creatinine more than 250 µmol/L, or presence of severe organ edema (e.g. pulmonary edema).

Exclusion Criteria:

were presence of a malignant tumor, chronic renal insufficiency (serum creatinine >133 µmol/L), 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

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
jianghua chen, MD	Kidney disease center, the first affiliated hospital, medical college of Zhejiang university	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kidney disease center, the first affiliated hospital, medical college of Zhejiang university		Hangzhou	Zhejiang	310003	China

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided