An Optimization in the Postoperative Treatment in Head and Neck--surgical Patients.

Not Applicable

• Conditions: Hyperglycemia Stress; Hyperglycemia Steroid-induced; Surgery--Complications
• Interventions: Other: Prevention of hyperglycemia

• Registration Number: NCT04021186
• Lead Sponsor: University of Copenhagen

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.

Study Timeline

• Status Verified: 2019-07
• Study Start: 2019-07-05
• Study First Submitted: 2019-07-05
• Study First Submitted QC: 2019-07-15
• Study First Posted: 2019-07-16
• Last Update Submitted: 2019-07-16
• Last Update Posted: 2019-07-17
• Primary Completion: 2020-08-17
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention	Prevention of hyperglycemia	Insulin treatment using standard measurements.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of re-Hospitalizations	Up to 3 months after the first discharge	counted
C-reactive protein (CRP) concentration	20 days	Blood sample - will be measured 3 times
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
Blood glucose (mmol/l)	1-5 days - every 30. min.	Will be measured by electronical device called Freestyle Libre (CGM)
Temperature (degree celcius)	1-5 days	The temperature will be measured 3 times a day for each participant
Intracellular hydration (liters)	20 days	Will be measured by bioimpedance and blood sample of hematocrit
Functional recovery	20 days	Performa status and FOIS (Functional Oral Intake Scale = degree of swallowing problems/dysphagia) scale will be used (points 1-7)

Trial Locations

Locations (1)

Clinic for Ear, Nose and Throat Surgery, Rigshospital; 🇩🇰 Copenhagen, Denmark