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Trial registered on ANZCTR


Registration number
ACTRN12614001145695
Ethics application status
Approved
Date submitted
16/10/2014
Date registered
29/10/2014
Date last updated
7/05/2019
Date data sharing statement initially provided
7/05/2019
Date results information initially provided
7/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Perioperative Administration of Dexamethasone and Glucose concentrations in diabetic and non-diabetic surgical patients
Scientific title
In diabetic and non-diabetic surgical patients, does the administration of perioperative dexamethasone compared to placebo, increase blood glucose concentrations
Secondary ID [1] 285510 0
None
Universal Trial Number (UTN)
U1111-1162-9647
Trial acronym
PADDAG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 293306 0
Surgery 293307 0
Condition category
Condition code
Anaesthesiology 293579 293579 0 0
Anaesthetics
Metabolic and Endocrine 293616 293616 0 0
Diabetes
Surgery 293617 293617 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Random allocation to either Placebo, Dexamethasone 4mg or 8mg IV at induction of anaesthesia, within EACH of two strata ( diabetic or non-diabetic )This will be determined according to their know diabetic status. The allocation will be by the use of a random number generator
Intervention code [1] 290450 0
Treatment: Drugs
Comparator / control treatment
Placebo ( intravenous saline bolus )
Control group
Placebo

Outcomes
Primary outcome [1] 293392 0
Peak postoperative blood glucose concentrations
Timepoint [1] 293392 0
Hourly intraoperatively, and up to 6 hourly postoperaively up to 24 hours
Secondary outcome [1] 310920 0
Surgical site infection as determined by microbiological culture or the use of antibiotics
Timepoint [1] 310920 0
30 days postoperatively
Secondary outcome [2] 310921 0
Postoperative nausea and vomiting as determined with a Verbal Response Scale
Timepoint [2] 310921 0
24 hours postoperatively
Secondary outcome [3] 310922 0
Acute Pain as determined with a Verbal Response Scale (VRS)
Timepoint [3] 310922 0
24 hours postoperatively
Secondary outcome [4] 310923 0
Quality of Recovery (QOR) using the QOR-15 tool
Timepoint [4] 310923 0
30 days
Secondary outcome [5] 310924 0
Disability [WHODAS]
Timepoint [5] 310924 0
One year
Secondary outcome [6] 310925 0
Chronic post-surgical pain using the mBPI and Neuropathic pain questionnaire
Timepoint [6] 310925 0
One year
Secondary outcome [7] 310926 0
Surgical Complications [Dindo-CLavien grade]
Timepoint [7] 310926 0
30 days
Secondary outcome [8] 310927 0
Length of hospital stay
Timepoint [8] 310927 0
Until discharged postoperatively
Secondary outcome [9] 310928 0
Sepsis using the Surviving Sepsis Guidelines and CDC criteria
Timepoint [9] 310928 0
30 days

Eligibility
Key inclusion criteria
Elective surgical patients
Skin incision required
Surgical duration greater than one hour
At least one night hospital stay postoperatively
General anaesthesia
ASA grade 1-4
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pure regional anaesthesia
Hypersensitivity to study drug
Poorly controlled Type 1 diabetes mellitus
Sickle cell anaemia
Thalassemia
Surgical procedure within the previous 3 months
Surgical procedure planned within 30 days of the index procedure
Infection within three months prior to procedure
Maxillofacial surgery
Intraoperative requirement
Renal Impairment
Immunosuppressive therapy or state
Concurrent systemic glucocorticoid usage
Moderate or severe liver disease
Metastatic cancer
Opthalmic surgery
Endovascular procedures


Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Stratification according to presence or absence of diabetes
Double blinded
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was conducted using permuted blocks, with stratification according to site to ensure balance across the strata at each site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Superiority design
We will need to recruit 112 experimental subjects and 112 control subjects, in each stratum ( diabetic and non-diabetic) , to be able to reject the null hypothesis with a Type I error of 0.05 and power of 0.8. Total cohort = 112 x 6 = 672. We will recruit 700 patients allowing for a dropout rate of 2.5%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3051 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 3052 0
Fremantle Hospital and Health Service - Fremantle
Recruitment postcode(s) [1] 8834 0
6000 - Perth
Recruitment postcode(s) [2] 8835 0
6160 - Fremantle

Funding & Sponsors
Funding source category [1] 290107 0
Charities/Societies/Foundations
Name [1] 290107 0
Medical Research Foundation
Address [1] 290107 0
Royal Perth Hospital
Box X2213
GPO Perth 6847
Western Australia
Country [1] 290107 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Wellington Street
Perth City
Western Australia
WA 6000
Country
Australia
Secondary sponsor category [1] 288843 0
None
Name [1] 288843 0
Address [1] 288843 0
Country [1] 288843 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291816 0
Fremantle Hospital Ethics Committee
Ethics committee address [1] 291816 0
Alma Street
Fremantle
6160
Western Australia
Ethics committee country [1] 291816 0
Australia
Date submitted for ethics approval [1] 291816 0
Approval date [1] 291816 0
14/08/2014
Ethics approval number [1] 291816 0
14/46

Summary
Brief summary
The proposed PADDAG trial is a prospective, stratified-randomised controlled trial to determine whether the use of intraoperative dexamethasone, a widely used antiemetic in adult surgical patients, is associated with an increased blood glucose concentration, and whether this increase is greater in patients with diabetes than in those without. Secondary outcomes will include the risk of infection, and the interaction between dexamethasone administration, diabetic status, glycaemic control and infective complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52146 0
Prof Tomas Corcoran
Address 52146 0
Department of Anaesthesia and Pain Medicine
Level 4, North Block
Royal Perth Hospital
Wellington Street
Perth
WA, 6000
Country 52146 0
Australia
Phone 52146 0
+61892241038
Fax 52146 0
Email 52146 0
tomas.corcoran@health.wa.gov.au
Contact person for public queries
Name 52147 0
Mrs Pauline Coutts
Address 52147 0
Department of Anaesthesia and Pain Medicine
Level 4, North Block
Royal Perth Hospital
Wellington Street
Perth
WA, 6000
Country 52147 0
Australia
Phone 52147 0
+61892241036
Fax 52147 0
Email 52147 0
Pauline.coutts@health.wa.gov.au
Contact person for scientific queries
Name 52148 0
Prof Tomas Corcoran
Address 52148 0
Department of Anaesthesia and Pain Medicine
Level 4, North Block
Royal Perth Hospital
Wellington Street
Perth
WA, 6000
Country 52148 0
Australia
Phone 52148 0
+61892241038
Fax 52148 0
Email 52148 0
tomas.corcoran@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary