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

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04021186
• Other study ID #: DM-HHC
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: July 2019
• Source: University of Copenhagen
• Contact: Sara K. Nielsen, Stud.Cand
• Phone: 29456529
• Email: qcw694[@]alumni.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Hyperglycemia
• Hyperglycemia Steroid-induced
• Hyperglycemia Stress
• Surgery--Complications

Intervention

Other:
• Prevention of hyperglycemia
Bigger focus on postoperative blood-glucose levels in order to reduce incidents of hyperglycemia and other surgical complications.

Locations

Country	Name	City	State
Denmark	Clinic for Ear, Nose and Throat Surgery, Rigshospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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