An Optimization in the Postoperative Treatment in Head and Neck--surgical Patients.
Primary Purpose
Hyperglycemia Steroid-induced, Hyperglycemia Stress, Surgery--Complications
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Prevention of hyperglycemia
Sponsored by
About this trial
This is an interventional prevention trial for Hyperglycemia Steroid-induced
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.
Sites / Locations
- Clinic for Ear, Nose and Throat Surgery, RigshospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Insulin treatment using standard measurements.
Standard care.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Temperature (degree celcius)
The temperature will be measured 3 times a day for each participant
C-Peptide
Blood sample - Will be measured 3 times
Strength of Hand grip (kg)
Will be measured 3 times. Maximal values of 3 attempts
Number of re-Hospitalizations
counted
Number of re-Hospitalizations
counted
Intracellular hydration (liters)
Will be measured by bioimpedance and blood sample of hematocrit
C-reactive protein (CRP) concentration
Blood sample - will be measured 3 times
Blood glucose (mmol/l)
Will be measured by electronical device called Freestyle Libre (CGM)
Functional recovery
Performa status and FOIS (Functional Oral Intake Scale = degree of swallowing problems/dysphagia) scale will be used (points 1-7)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04021186
Brief Title
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
August 17, 2020 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia Steroid-induced, Hyperglycemia Stress, Surgery--Complications
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Insulin treatment using standard measurements.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard care.
Intervention Type
Other
Intervention Name(s)
Prevention of hyperglycemia
Intervention Description
Bigger focus on postoperative blood-glucose levels in order to reduce incidents of hyperglycemia and other surgical complications.
Primary Outcome Measure Information:
Title
Glycemic load (mmol)
Description
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.
Time Frame
1-5 days
Secondary Outcome Measure Information:
Title
Temperature (degree celcius)
Description
The temperature will be measured 3 times a day for each participant
Time Frame
1-5 days
Title
C-Peptide
Description
Blood sample - Will be measured 3 times
Time Frame
1-5 days
Title
Strength of Hand grip (kg)
Description
Will be measured 3 times. Maximal values of 3 attempts
Time Frame
20 days
Title
Number of re-Hospitalizations
Description
counted
Time Frame
30 days postoperatively
Title
Number of re-Hospitalizations
Description
counted
Time Frame
Up to 3 months after the first discharge
Title
Intracellular hydration (liters)
Description
Will be measured by bioimpedance and blood sample of hematocrit
Time Frame
20 days
Title
C-reactive protein (CRP) concentration
Description
Blood sample - will be measured 3 times
Time Frame
20 days
Title
Blood glucose (mmol/l)
Description
Will be measured by electronical device called Freestyle Libre (CGM)
Time Frame
1-5 days - every 30. min.
Title
Functional recovery
Description
Performa status and FOIS (Functional Oral Intake Scale = degree of swallowing problems/dysphagia) scale will be used (points 1-7)
Time Frame
20 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara K. Nielsen, Stud.Cand
Phone
29456529
Ext
+45
Email
qcw694@alumni.ku.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Josefine Q. Olsen, Stud.Cand
Phone
42232425
Ext
+45
Email
bgc796@alumni.ku.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens R. Andersen, AP, MD, MPA
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic for Ear, Nose and Throat Surgery, Rigshospital
City
Copenhagen
ZIP/Postal Code
2100 Cph OE
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens R Andersen, MD, MPA
Phone
+4523346654
Email
jra@life.ku.dk
First Name & Middle Initial & Last Name & Degree
Irene Wessel, MD. PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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An Optimization in the Postoperative Treatment in Head and Neck--surgical Patients.
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