Hyperglycemia Steroid-induced, Hyperglycemia Stress, Surgery--Complications
Conditions
Brief summary
Based on glycemic load (overall increase in blood glucose), it is investigated whether better glycemic control (large fluctuations in blood glucose to abnormal values are attempted) can improve the postoperative phase of head and neck surgical patients who receive Dexamethasone (glucocorticoid). Furthermore it is examined whether this optimization in treatment can result in reduced hospitalization time and fewer re-admissions. Hypothesis: Continuous blood glucose measurement and insulin therapy will optimize the postoperative phase of the embedded head and neck patient receiving Dexamethasone by reducing the incidence of hyperglycaemia and associated complications.
Detailed description
After surgical intervention, an insulin resistance condition will occur because of the following stress response. This condition will for the majority of cases results in poor glycemic control - and there will be a risk of hyperglycaemia in the hospitalized patient. This condition affects all cells in the body and therefore has associated complications such as bigger risk at multiple infections, longer healingprocess, poorer fluid balance, etc. Hyperglycaemia is associated with a poorer outcome for the patient, which can cause an increase in hospitalization days and multiple re-admissions. It is also common for the postoperative patient to experience nausea and pain as a result of both surgery and anesthesia and immobilization. To counter this, the patient receives Dexamethasone (steroid treatment). This experiment is based on the fact that there is still insufficient attention at this postoperative insulin resistance. In a large randomized study from 2001(Van den Berghe), insulin therapy was initiated for intensive patients. This study points out that even moderate increases in blood glucose are associated with increased morbidity and that insulin therapy is both capable of reducing mortality and morbidity.
Interventions
OTHERPrevention of hyperglycemia
Bigger focus on postoperative blood-glucose levels in order to reduce incidents of hyperglycemia and other surgical complications.
Sponsors
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prevention of hyperglycemia. The study will involve an intervention and a control group - only the intervention group will receive different treatment and the other standard care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All embedded head and neck-surgical patients receiving large packs of pre-medication, including 8-16 mg glucocorticoid. * \>18 yrs. * Expected admission time of a minimum of 1 day
Exclusion criteria
* Patients who do not understand and / or speak Danish * Patients who are demented * Patients included in primary robot surgery * Ear-surgical patients * Sinus surgery patients * Day surgery patients * Plastic surgical patients * Patients who are scheduled to transfer to ICU * Patients with Diabetes Mellitus type I * Patients on dialysis * If all preoperative blood samples and tests are not completed * Type 2 diabetics in insulin therapy * Anesthesia patients * Patients who have received large packages of pre-medication twice - eg. due to cancelled operation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic load (mmol) | 1-5 days | All blood glucose levels of the participants will be measured every 30. min - all values will be used to make an area under the curve in final statistics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-Peptide | 1-5 days | Blood sample - Will be measured 3 times |
| Strength of Hand grip (kg) | 20 days | Will be measured 3 times. Maximal values of 3 attempts |
| Number of re-Hospitalizations | 30 days postoperatively | counted |
| Temperature (degree celcius) | 1-5 days | The temperature will be measured 3 times a day for each participant |
| C-reactive protein (CRP) concentration | 20 days | Blood sample - will be measured 3 times |
| Blood glucose (mmol/l) | 1-5 days - every 30. min. | Will be measured by electronical device called Freestyle Libre (CGM) |
| Functional recovery | 20 days | Performa status and FOIS (Functional Oral Intake Scale = degree of swallowing problems/dysphagia) scale will be used (points 1-7) |
| Intracellular hydration (liters) | 20 days | Will be measured by bioimpedance and blood sample of hematocrit |
Countries
Denmark
Contacts
Primary ContactSara K. Nielsen, Stud.Cand
Backup ContactJosefine Q. Olsen, Stud.Cand
Outcome results
None listed