Development of a Biological Database in the Field of Oper... | NCT03014427

Studies
Development of a Biological Database in the Field of Operative Intensive Care

NCT03014427

Sponsor

RWTH Aachen University

Status

Recruiting

Last Update Posted

Sep 18, 2019Actual

Enrollment

99,999,999Estimated

Phase

Not provided

Conditions

Intensive Care in General

Interventions

Biological Database

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

Sep 2019

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2017Actual

Primary Completion Date

Feb 2050Estimated

Completion Date

Feb 2050Estimated

First Submitted Date

Jan 6, 2017

First Submission Date that Met QC Criteria

Jan 6, 2017

First Posted Date

Jan 9, 2017Estimated

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

Sep 17, 2019

Last Update Posted Date

Sep 18, 2019Actual

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 storage and use of biomaterial samples is an important requirement for accompanying research and the acquisition of new knowledge to improve prognosis and therapy. Biobanking is explicitly recommended in official guidelines. In order to preserve the biomaterial, the patient must consent to the removal, transfer and storage of the biomaterial separately from the consent to the register. The biomaterial is taken at times at which a blood or urine sampling takes place anyway in the clinical routine. Therefore no additional interventions are necessary.

Detailed Description

Sample volumes are defined as follows:

Peripheral blood: up to a total of 150 ml distributed to a maximum of 10 morning blood samples (approximately 15 ml blood per blood sample) during the inpatient stay in the intensive care unit (fixed times are admission and discharge of the intensive care unit)
Urine: a total of up to 200 ml of catheter urine distributed to a maximum of 10 morning withdrawals during inpatient stays in the intensive care unit (defined times are admission and discharge from the intensive care unit)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

99,999,999Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biological Database	Other	Biological Database

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Interleukin 6 value [nmol/l]	Record of clinically relevant parameters	10 days
Interleukin 10 [nmol/l]	Record of clinically relevant parameters	10 days
Adrenomedullin value [nmol/l]	Record of clinically relevant parameters	10 days
Tumornekrosefaktor alpha [nmol/l]	Record of clinically relevant parameters	10 days
Procalcitonin [nmol/l]	Record of clinically relevant parameters	10 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients after admission to the intensive care unit
18 years or older
signed informed consent

Exclusion Criteria:

No exclusion criteria are formulated with regard to the objective of the register to record intensive care patients in general. Patients with multiple comorbidities, organ dysfunctions, and non-compliance for a curatively-intended therapy should also be recorded in the register. A palliative treatment or decision for best supportive care is not an exclusion criterion for registering.

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 patients in general

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christina Kalvelage, M. Sc.	Contact	0241 80 36485		ckalvelage@ukaachen.de
Christian Stoppe, Dr. med.	Contact	0241 80 36575		cstoppe@ukaachen.de

Overall Officials

Name	Affiliation	Role
Christian Stoppe, Dr. med.	Operative Medicine and Intensive Care, RWTH Aachen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uniklinik RWTH Aachen	Recruiting	Aachen		52074	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16328180	Background	Bestehorn K. [Medical registries]. Med Klin (Munich). 2005 Nov 15;100(11):722-8. doi: 10.1007/s00063-005-1098-x. German.
	Background	Schott G, Berthold HK. Pharmakovigilanz: Empfehlungen zur Meldung unerwünschter Arzneimittelwirkungen durch die Ärzteschaft. Arzneiverordnung in der Praxis. 2005.