Clinical trial NCT04021186: An Optimization in the Postoperative Treatment in Head and Neck--surgical Patients.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperglycemia Steroid-induced
Hyperglycemia Stress
Surgery--Complications
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glycemic load (mmol)
timeFrame: 1-5 days
Secondary outcomes:
measure: Temperature (degree celcius)
timeFrame: 1-5 days
measure: C-Peptide
timeFrame: 1-5 days
measure: Strength of Hand grip (kg)
timeFrame: 20 days
measure: Number of re-Hospitalizations
timeFrame: 30 days postoperatively
measure: Number of re-Hospitalizations
timeFrame: Up to 3 months after the first discharge
measure: Intracellular hydration (liters)
timeFrame: 20 days
measure: C-reactive protein (CRP) concentration
timeFrame: 20 days
measure: Blood glucose (mmol/l)
timeFrame: 1-5 days - every 30. min.
measure: Functional recovery
timeFrame: 20 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Clinic for Ear, Nose and Throat Surgery, Rigshospital
Study officials:
affiliation: University of Copenhagen
name: Jens R. Andersen, AP, MD, MPA
role: PRINCIPAL_INVESTIGATOR
References: