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

Recruiting

• Conditions: Intensive Care in General

• Registration Number: NCT03014427
• Lead Sponsor: RWTH Aachen University

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)

Study Timeline

• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-01-06
• Study First Posted: 2017-01-09
• Study Start: 2017-03-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-18
• Primary Completion: 2050-02
• Study Completion: 2050-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 99999999

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Uniklinik RWTH Aachen; 🇩🇪 Aachen, Germany