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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Surgery--Complications; Hyperglycemia Stress; Hyperglycemia Steroid-induced
• Intervention / Treatment: Other: Prevention of hyperglycemia

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100 Cph OE
    • Recruiting
    • Clinic for Ear, Nose and Throat Surgery, Rigshospital
    • Contact: Jens R Andersen, MD, MPA; Phone Number: +4523346654; Email: jra@life.ku.dk
    • Sub-Investigator: Irene Wessel, MD. PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard care.
Experimental: Intervention; Insulin treatment using standard measurements.	Other: Prevention of hyperglycemia; Bigger focus on postoperative blood-glucose levels in order to reduce incidents of hyperglycemia and other surgical complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Investigators: Principal Investigator: Jens R. Andersen, AP, MD, MPA, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2019
• Primary Completion (Anticipated): August 17, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: July 5, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): July 17, 2019
• Last Update Submitted That Met QC Criteria: July 16, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: DM-HHC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No