Mineral-Homeostasis in Continuous Renal Replacement Therapy | NCT01946113

Studies
Mineral-Homeostasis in Continuous Renal Replacement Therapy

NCT01946113

Sponsor

Heinrich-Heine University, Duesseldorf

Status

Completed

Last Update Posted

Aug 20, 2015Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Acute Renal Failure

Interventions

Not provided

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

Aug 2015

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

Sep 2013

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Sep 9, 2013

First Submission Date that Met QC Criteria

Sep 16, 2013

First Posted Date

Sep 19, 2013Estimated

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

Aug 19, 2015

Last Update Posted Date

Aug 20, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Klinik für Anästhesiologie, Prof. Kindgen-Milles, Heinrich-Heine University, DuesseldorfPrincipal Investigator

Lead Sponsor

Heinrich-Heine University, DuesseldorfOTHER

Collaborators

Not provided

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

Acute renal failure is a common complication in intensive care unit patients. In 10% of cases renal replacement therapy becomes necessary. Current devices have increase filter patency and efficacy. However, magnesium, calcium and phosphate are eliminated as well. However, the extend of this elimination hase not been quantified. Thus, we want to

record retrospectively how often abnormal values for phosphate, magnesium and calcium occurred during routine renal replacement therapy in 2011 and 2012.
prospectively evaluate the same parameters during routine treatment in 2013 and 2014

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Retrospektive Cohort		Patients requiring renal replacement therapy from 2011 to 2012 on intensive care unit
Prospektive Cohort		Patients requiring renal replacement on intensive care unit in 2013 and 2014

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of hypo-phosphate,-magnesium and calcaemia	Participants will be followed for the duration of ICU stay, an expected average of 28 days	approximately 28 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

intensive care unit patients with acute renal failure undergoing continuous renal replacement therapy
older than 18 years of age

Exclusion Criteria:

age less than 18 years
pregnancy
contraindications against continuous renal replacement therapy

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

intensive care unit patients with acute renal failure undergoing renal replacement therapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Detlef Kindgen-Milles, Prof.	Department of Anaesthesiology, Duesseldorf University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Interdisziplinäre Intensivstation Universitätsklinikum Düsseldorf		Düsseldorf		40225	Germany

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided