Surgery--Complications Clinical Trial
Official title:
An Optimization in the Postoperative Treatment in Head and Neck--surgical Patients -- Improvement in Glycemic Control to Reduce the Incidence of Hyperglycaemia and Associated Complications.
NCT number | NCT04021186 |
Other study ID # | DM-HHC |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 5, 2019 |
Est. completion date | November 30, 2020 |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | November 30, 2020 |
Est. primary completion date | August 17, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Clinic for Ear, Nose and Throat Surgery, Rigshospital | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glycemic load (mmol) | 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. | 1-5 days | |
Secondary | Temperature (degree celcius) | The temperature will be measured 3 times a day for each participant | 1-5 days | |
Secondary | C-Peptide | Blood sample - Will be measured 3 times | 1-5 days | |
Secondary | Strength of Hand grip (kg) | Will be measured 3 times. Maximal values of 3 attempts | 20 days | |
Secondary | Number of re-Hospitalizations | counted | 30 days postoperatively | |
Secondary | Number of re-Hospitalizations | counted | Up to 3 months after the first discharge | |
Secondary | Intracellular hydration (liters) | Will be measured by bioimpedance and blood sample of hematocrit | 20 days | |
Secondary | C-reactive protein (CRP) concentration | Blood sample - will be measured 3 times | 20 days | |
Secondary | Blood glucose (mmol/l) | Will be measured by electronical device called Freestyle Libre (CGM) | 1-5 days - every 30. min. | |
Secondary | Functional recovery | Performa status and FOIS (Functional Oral Intake Scale = degree of swallowing problems/dysphagia) scale will be used (points 1-7) | 20 days |
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