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出境医 / 临床实验 / An Optimization in the Postoperative Treatment in Head and Neck--surgical Patients.

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

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.


Condition or disease Intervention/treatment Phase
Hyperglycemia Steroid-induced Hyperglycemia Stress Surgery--Complications Other: Prevention of hyperglycemia Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Actual Study Start Date : July 5, 2019
Estimated Primary Completion Date : August 17, 2020
Estimated Study Completion Date : November 30, 2020
Arms and Interventions
Arm Intervention/treatment
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.
No Intervention: Control
Standard care.
Outcome Measures
Primary Outcome Measures :
  1. Glycemic load (mmol) [ Time Frame: 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 :
  1. Temperature (degree celcius) [ Time Frame: 1-5 days ]
    The temperature will be measured 3 times a day for each participant

  2. C-Peptide [ Time Frame: 1-5 days ]
    Blood sample - Will be measured 3 times

  3. Strength of Hand grip (kg) [ Time Frame: 20 days ]
    Will be measured 3 times. Maximal values of 3 attempts

  4. Number of re-Hospitalizations [ Time Frame: 30 days postoperatively ]
    counted

  5. Number of re-Hospitalizations [ Time Frame: Up to 3 months after the first discharge ]
    counted

  6. Intracellular hydration (liters) [ Time Frame: 20 days ]
    Will be measured by bioimpedance and blood sample of hematocrit

  7. C-reactive protein (CRP) concentration [ Time Frame: 20 days ]
    Blood sample - will be measured 3 times

  8. Blood glucose (mmol/l) [ Time Frame: 1-5 days - every 30. min. ]
    Will be measured by electronical device called Freestyle Libre (CGM)

  9. Functional recovery [ Time Frame: 20 days ]
    Performa status and FOIS (Functional Oral Intake Scale = degree of swallowing problems/dysphagia) scale will be used (points 1-7)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Sara K. Nielsen, Stud.Cand 29456529 ext +45 qcw694@alumni.ku.dk
Contact: Josefine Q. Olsen, Stud.Cand 42232425 ext +45 bgc796@alumni.ku.dk

Locations
Layout table for location information
Denmark
Clinic for Ear, Nose and Throat Surgery, Rigshospital Recruiting
Copenhagen, Denmark, 2100 Cph OE
Contact: Jens R Andersen, MD, MPA    +4523346654    jra@life.ku.dk   
Sub-Investigator: Irene Wessel, MD. PhD         
Sponsors and Collaborators
University of Copenhagen
Investigators
Layout table for investigator information
Principal Investigator: Jens R. Andersen, AP, MD, MPA University of Copenhagen
Tracking Information
First Submitted Date  ICMJE July 5, 2019
First Posted Date  ICMJE July 16, 2019
Last Update Posted Date July 17, 2019
Actual Study Start Date  ICMJE July 5, 2019
Estimated Primary Completion Date August 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019) 		Glycemic load (mmol) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • Temperature (degree celcius) [ Time Frame: 1-5 days ]
    The temperature will be measured 3 times a day for each participant
  • C-Peptide [ Time Frame: 1-5 days ]
    Blood sample - Will be measured 3 times
  • Strength of Hand grip (kg) [ Time Frame: 20 days ]
    Will be measured 3 times. Maximal values of 3 attempts
  • Number of re-Hospitalizations [ Time Frame: 30 days postoperatively ]
    counted
  • Number of re-Hospitalizations [ Time Frame: Up to 3 months after the first discharge ]
    counted
  • Intracellular hydration (liters) [ Time Frame: 20 days ]
    Will be measured by bioimpedance and blood sample of hematocrit
  • C-reactive protein (CRP) concentration [ Time Frame: 20 days ]
    Blood sample - will be measured 3 times
  • Blood glucose (mmol/l) [ Time Frame: 1-5 days - every 30. min. ]
    Will be measured by electronical device called Freestyle Libre (CGM)
  • Functional recovery [ Time Frame: 20 days ]
    Performa status and FOIS (Functional Oral Intake Scale = degree of swallowing problems/dysphagia) scale will be used (points 1-7)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • Temperature (degree celcius) [ Time Frame: 1-5 days ]
    The temperature will be measured 3 times a day for each participant
  • C-Peptide [ Time Frame: 1-5 days ]
    Blood sample - Will be measured 3 times
  • Strength of Hand grip (kg) [ Time Frame: 20 days ]
    Will be measured 3 times. Maximal values of 3 attempts
  • Number of re-Hospitalizations [ Time Frame: 30 days postoperatively ]
    counted
  • Number of re-Hospitalizations [ Time Frame: Up to 3 months after the first discharge ]
    counted
  • Intracellular hydration (liters) [ Time Frame: 20 days ]
    Will be measured by bioimpedance and blood sample of hematocrit
  • C-reactive protein (CRP) concentration [ Time Frame: 20 days ]
    Blood sample - will be measured 3 times
  • Blood glucose (mmol/l) [ Time Frame: 1-5 days - every 30. min. ]
    Will be measured by electronical device called Freestyle Libre (CGM)
  • Functional recovery [ Time Frame: 20 days ]
    Performa status and FOIS scale will be used (points on scale)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Optimization in the Postoperative Treatment in Head and Neck--surgical Patients.
Official Title  ICMJE 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Hyperglycemia Steroid-induced
  • Hyperglycemia Stress
  • Surgery--Complications
Intervention  ICMJE Other: Prevention of hyperglycemia
Bigger focus on postoperative blood-glucose levels in order to reduce incidents of hyperglycemia and other surgical complications.
Study Arms  ICMJE
  • Experimental: Intervention
    Insulin treatment using standard measurements.
    Intervention: Other: Prevention of hyperglycemia
  • No Intervention: Control
    Standard care.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 15, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date August 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sara K. Nielsen, Stud.Cand 29456529 ext +45 qcw694@alumni.ku.dk
Contact: Josefine Q. Olsen, Stud.Cand 42232425 ext +45 bgc796@alumni.ku.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04021186
Other Study ID Numbers  ICMJE DM-HHC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jens Rikardt Andersen, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jens R. Andersen, AP, MD, MPA University of Copenhagen
PRS Account University of Copenhagen
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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