DRKS00027085
Completed
N/A
Evaluation of the performance and safety of the intravascular ivCGM continuous glucose monitoring system in hospitalized patients in critical care units - ivCGM-P2
A. Menarini Diagnostics S.r.l.0 sites35 target enrollmentNovember 11, 2021
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hospitalized patients in cardiac surgery ICU.
- Sponsor
- A. Menarini Diagnostics S.r.l.
- Enrollment
- 35
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Hospitalized patients in cardiac surgery ICU.
- •2\. Age \>18 years
- •3\. An understanding of and willingness to follow the study protocol and sign the informed consent
- •4\. At least 10, maximum 20 with type 1 or type 2 diabetes
Exclusion Criteria
- •1\. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
- •2\. Any serious medical conditions or disability which, in the opinion of the investigator, would interfere with treatment or assessment or would preclude completion of the study
- •3\. Pregnancy or breastfeeding
- •4\. History of bleeding disorder
- •5\. History of heparin\-induced thrombocytopenia (HIT)
- •6\. Significant acute or chronic illness that might interfere with patient safety or integrity of results as judged by the Investigator
- •7\. Anemia with Hb \< 7\.5 g/dL
- •8\. Known hypersensitivity to Fondaparinux sodium (Arixtra®)
- •9\. Patient currently participating in an investigational clinical study that interferes with the execution of the study.
- •10\. Absence of suitable vein for iv catheter and Probe insertion, as judged by the Investigator: (cephalic vein highly recommended; median antebrachial vein to be avoided; other veins to be chosen at Investigator’s discretion)
Outcomes
Primary Outcomes
Not specified
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