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Critically ill patients are on high risk for increased serum glucose levels, leading to more comorbidity and higher mortality risk. In patients with severe sepsis and septic shock hyperglycemia is a typical finding. However the need of insulin therapy is associated with an increased risk of hypoglycemia. Newly developed technologies for continuous glucose monitoring in critically ill patients may improve glycemic control and reduce glucose variability. The investigators will perform continuous glucose monitoring in critically ill patients on ICU. Measurements will be done for a period of 72h per patient. The investigators aim is to evaluate accuracy feasibility and acceptance of these methods. To analyze accuracy sensor glucose levels will be validated due to arterial blood gas measurements with the blood gas analyzer. The investigators will investigate the influence of several factors like oedema, perspiration, BMI, body temperature, pH-value application of vasoconstrictors on accuracy and feasibility of the particular system. Furthermore Nursing staff will be given a questionnaire to identify acceptance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOFA <7 | Other | Critically ill patients with a Sequential Organ Failure Assessment (SOFA) score < 7 at first day of measurement. Intervention: Measuring continuous glucose monitoring. |
|
| SOFA >7 | Other | Critically ill patients with a Sequential Organ Failure Assessment (SOFA) score > 7 at first day of measurement. Intervention: Measuring continuous glucose monitoring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitoring | Device | Continuous glucose monitoring by subcutaneous or intravasal device for 72 hours. In use MEDTRONIC SENTRINO® and Edwards GlucoClear® systems. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of continuous glucose monitoring compared to blood gas analyses | Difference between glucose values of continuous glucose monitoring and blood gas analyses | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of continuous glucose monitoring | Problems within the application of sensor and monitoring during ward routine | 72 hours |
| Acceptance of continuous glucose monitoring by physicians and nursing staff |
| Measure | Description | Time Frame |
|---|---|---|
| Technical problems with the monitoring | Number of needed sensors per patient. Duration of functional sensor. Number and reasons for accidentally sensor removal. | up to 72 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steffen Weber-Carstens, MD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charite University, Berlin, Germany | Berlin | 13353 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27439710 | Result | Wollersheim T, Engelhardt LJ, Pachulla J, Moergeli R, Koch S, Spies C, Hiesmayr M, Weber-Carstens S. Accuracy, reliability, feasibility and nurse acceptance of a subcutaneous continuous glucose management system in critically ill patients: a prospective clinical trial. Ann Intensive Care. 2016 Dec;6(1):70. doi: 10.1186/s13613-016-0167-z. Epub 2016 Jul 21. |
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| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
Acceptance and evaluation of the device by physicians and nursing staff evaluated by questionnaire
| 72 hours |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |