Uniklinik RWTH Aachen
Aachen, 52074, Germany
Location status: Recruiting
Recruiting
NCT Number: NCT03014427
Development of a Biological Database in the Field of Operative Intensive Care
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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)
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Biological Database
OtherBiological Database
Primary outcomes
-
Interleukin 6 value [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
-
Procalcitonin [nmol/l]
Time frame: 10 days
Record of clinically relevant parameters
Study contacts
Contact information is provided by the study sponsor or research team.
Christian Stoppe, Dr. med.
CONTACT
Christina Kalvelage, M. Sc.
CONTACT
Sponsors and collaborators
Lead sponsor
RWTH Aachen University
Other
Registry information
Official study title
Development of a Biological Database in the Field of Operative Intensive Care for the Recording of Clinically Relevant Parameters of Critically Ill Intensive Patients
Acronym: Biobank OIM
Important dates
- Study start
- 2017
- Primary completion
- 2050
- Study completion
- 2050
- First posted
- Jan 9, 2017
- Registry last updated
- Sep 18, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.