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Clinical Trials/NCT03014427
NCT03014427
Recruiting
Not Applicable

Development of a Biological Database in the Field of Operative Intensive Care for the Recording of Clinically Relevant Parameters of Critically Ill Intensive Patients

RWTH Aachen University1 site in 1 country99,999,999 target enrollmentMarch 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intensive Care in General
Sponsor
RWTH Aachen University
Enrollment
99999999
Locations
1
Primary Endpoint
Interleukin 6 value [nmol/l]
Status
Recruiting
Last Updated
6 years ago

Overview

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

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. 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)

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
February 2050
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Interleukin 6 value [nmol/l]

Time Frame: 10 days

Record of clinically relevant parameters

Procalcitonin [nmol/l]

Time Frame: 10 days

Record of clinically relevant parameters

Interleukin 10 [nmol/l]

Time Frame: 10 days

Record of clinically relevant parameters

Adrenomedullin value [nmol/l]

Time Frame: 10 days

Record of clinically relevant parameters

Tumornekrosefaktor alpha [nmol/l]

Time Frame: 10 days

Record of clinically relevant parameters

Study Sites (1)

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