Bundle Evaluation in Extra Renal Epuration, Incidence of... | NCT01560364

Studies
Bundle Evaluation in Extra Renal Epuration, Incidence of Thrombosis

NCT01560364

Sponsor

University Hospital, Clermont-Ferrand

Status

Completed

Last Update Posted

Dec 2, 2014Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Adults Receiving Renal Replacement Therapy

Interventions

renal replacement therapy

Countries

France

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

Nov 2014

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

May 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Oct 17, 2011

First Submission Date that Met QC Criteria

Mar 20, 2012

First Posted Date

Mar 22, 2012Estimated

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 28, 2014

Last Update Posted Date

Dec 2, 2014Estimated

Description Module

Brief Summary

This is a prospective observational clinical multicentric study in ICU with acute renal failure requiring renal replacement therapy.

Detailed Description

Prospective before / after observational clinical multicentric study on ICU acute kidney injury during renal replacement therapy. Evaluation of incidence and exposure to hemofilter clotting.

The after phase will consist in medical measures (help for prescription) and paramedical measures (stop the filtration flow during the patient's mobilization).

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hemofilter			Other: renal replacement therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
renal replacement therapy	Other	Prospective observational clinical multicentric study in ICU with acute renal failure requiring renal replacement therapy.	Hemofilter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemofilter lifetime		at day 1

Secondary Outcomes

Measure	Description	Time Frame
Hemofilter clotting risk factors		at day 1
hemofiltration duration		at day 1
down time value

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult (age > 18 years)
Renal replacement therapy (continuous veino-veinous hemofiltration or continuous veino-veinous hemodiafiltration)
Consent of patients

Exclusion Criteria:

Use citrate anticoagulation
Age below 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults receiving renal replacement therapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sébastien PERBET	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Clermont-Ferrand		Clermont-Ferrand		63003	France