Stability of Middle Molecule Clearance | NCT01308073

Studies
Stability of Middle Molecule Clearance

NCT01308073

Sponsor

Klinik für Anästhesiologie

Status

Completed

Last Update Posted

Dec 19, 2014Estimated

Enrollment

15Actual

Phase

Not provided

Conditions

Continuous Hemodialysis

Interventions

Hemodialysis with EMIC 2 filters

Countries

Germany

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 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

Mar 2011

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Feb 4, 2011

First Submission Date that Met QC Criteria

Mar 2, 2011

First Posted Date

Mar 3, 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 18, 2014

Last Update Posted Date

Dec 19, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Klinik für Anästhesiologie, Leiter Interdisziplinäre Operative Intensivstation ZOM-I, Heinrich-Heine University, DuesseldorfSponsor-Investigator

Lead Sponsor

Klinik für AnästhesiologieOTHER

Collaborators

Name	Class
Fresenius Medical Care Deutschland GmbH	INDUSTRY

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

The investigators aim to show, whether all middle molecules are included in the clearance and whether this clearance is stable until 72 hours.

Detailed Description

A better middle molecule clearance has been shown until 24 hours of duration. The investigators will extend our observations until 72 hours.

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

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EMIC 2 dialysis		Patients on ICU requiring dialysis for acute renal insufficiency	Device: Hemodialysis with EMIC 2 filters

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hemodialysis with EMIC 2 filters	Device	Patients with indication for routine continuous hemodialysis due to acute renal insufficiency	EMIC 2 dialysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clearance of Urea		up to 72 h
Clearance of Cystatin C		up to 72 h
Clearance of creatinine		up to 72 h
Clearance of Beta2-Microglobulin		up to 72 h
Clearance of Osteocalcin		up to 72 h
Free light chains kappa of Immunoglobulins		up to 72 h
Clearance of albumin		up to 72 h

Secondary Outcomes

Measure	Description	Time Frame
Mean arterial pressure		up to 72 h
Vasopressor requirement		up to 72 h
Heart rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

informed consent
age>18 years
acute renal insufficiency with indication for continuous hemodialysis, according to RILFE classification F: serum creatinine increase > 3-fold or serum creatinine > 4mg/dl with acute increase of >0,5mg/dl Urine Output <0,3mg/kg/h for 24 h or anuria for 12 h
body weight:60-80kg
anticoagulation with citrate possible and indicated
Dose for hemodialysis of 2l/h

Exclusion Criteria:

participation in another clinical trial within on month prior to this study
pregnancy or brest feeding
septic shock
interference with cystatin-C
1. haemolysis <1g/dl
2. Bilirubin<9mg/dl
3. Triglyceride >700mg/dl
4. rheumatoid factor > 300kIU/l

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

Patients of surgical intensive care unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Detlef Kindgen-Milles, Prof.	Klinik für Anästhesiologie Universitätsklinikum Düsseldorf Heinrich-Heine Universität	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Intensivstation ZOM1 Klinik für Anästhesiologie Universitätsklinikum Düsseldorf		Düsseldorf		40225	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D006435	Renal Dialysis

Ancestor Terms

ID	Term
D017582	Renal Replacement Therapy
D013812	Therapeutics
D016060	Sorption Detoxification

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