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Trial registered on ANZCTR


Registration number
ACTRN12617001367336
Ethics application status
Approved
Date submitted
31/08/2017
Date registered
27/09/2017
Date last updated
31/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
In the intensive care setting immediately after Coronary Artery Bypass surgery, what is the glucose management range associated with the best outcomes?
Scientific title
Determination of the optimal glucose management range during critical care management post Coronary Artery Bypass surgery.
Secondary ID [1] 289736 0
Nil known
Universal Trial Number (UTN)
Trial acronym
OGRE-CABG (Optimal Glucose RangE for post-op CABG)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery bypass surgery 299582 0
Post-operative glucose management 299583 0
Stress hyperglycaemia 299664 0
Condition category
Condition code
Metabolic and Endocrine 299548 299548 0 0
Diabetes
Surgery 299549 299549 0 0
Other surgery
Cardiovascular 303942 303942 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients undergoing elective or semi-urgent Coronary Artery Bypass Graft surgery at Flinders Medical Centre will be identified using the ANZ Cardiac Surgery Registry. The glucose range associated with optimal post-operative outcomes in the 30 day post-op period will be determined.
Glucose ranges tested will be defined by both absolute glucose ranges, and the Stress Hyperglycaemia Ratio. SHR is defined by the time-weighted glucose during ICU stay divided by the estimated average glycaemia ( as calculated from the HbA1c using the formula developed by Nathan et al. Diab Care 2008;31:1473–14788. The study is retrospective - patients will have undergone routine post-op intensive care. Pathology results used in the analysis will be those already available through routine care.
Intervention code [1] 295434 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299080 0
Combined endpoint for adverse outcomes - mortality, infection (deep and superficial sternal wound infection, bacteraemia, pneumonia), respiratory failure (need for ventilator assistance for longer than 48 h), acute kidney injury (increase in creatinine level 40% from baseline), new MI, new CCF, new arrhythmias, stroke,hospital readmissions within 30 days related to the procedure as determined by the ANZ Cardiac Surgery Registry.
Timepoint [1] 299080 0
up to 30 days post discharge
Secondary outcome [1] 326087 0
Readmission
Timepoint [1] 326087 0
up to 30 days post discharge as determined by the ANZ Cardiac Surgery Registry
Secondary outcome [2] 338599 0
infection
Timepoint [2] 338599 0
up to 30 days post discharge as determined by the ANZ Cardiac Surgery Registry
Secondary outcome [3] 338600 0
Myocardial infarction
Timepoint [3] 338600 0
the hospital admission period as determined by the ANZ Cardiac Surgery Registry
Secondary outcome [4] 339015 0
new arrythmias
Timepoint [4] 339015 0
the hospital admission period as determined by the ANZ Cardiac Surgery Registry
Secondary outcome [5] 339016 0
stroke
Timepoint [5] 339016 0
the hospital admission period as determined by the ANZ Cardiac Surgery Registry
Secondary outcome [6] 339017 0
Mortality
Timepoint [6] 339017 0
the hospital admission period as determined by the ANZ Cardiac Surgery Registry
Secondary outcome [7] 339018 0
Respiratory failure (>48hours of ventilator assistance)
Timepoint [7] 339018 0
the hospital admission period as determined by the ANZ Cardiac Surgery Registry
Secondary outcome [8] 339019 0
acute kidney injury (increase of 40% or more from baseline creatinine)
Timepoint [8] 339019 0
the hospital admission period as determined by the ANZ Cardiac Surgery Registry
Secondary outcome [9] 339020 0
new onset exacerbation of heart failure
Timepoint [9] 339020 0
the hospital admission period as determined by the ANZ Cardiac Surgery Registry

Eligibility
Key inclusion criteria
Patients undergoing elective or semi-urgent Coronary Artery Bypass Graft surgery with or without other concurrent cardiac surgery.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
<18 years age, pregnant, emergency surgery, GFR<30ml/min/sq.m., hepatic failure, history of hyperglycaemic crisis.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
ROC curves will be used to ascertain AUC, sensitivity, and specificity of pre-defined ranges, including ranges designated by both the relative and absolute changes in glucose during post-op critical care management. Best final model will be determined using AUC, specificity and sensitivity from ROC curves in consideration with the lowest OR for adverse outcomes associated with Time-In-Range using multivariable regression. Following variables to be used:
- Time In Range
- APACHE lllj
- lactate
- CABG, re-do CABG, CABG + other cardiac surgery
- other variables depending on results of univariable analysis and degree of co-linearity
The successful model will then be applied to a validation sample to determine reproducibility.
We will use a cohort of 2500 patients identified in the SHR-CABG study (also listed on ANZCTR)

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)
SA
Recruitment hospital [1] 6301 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 13835 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 294158 0
Hospital
Name [1] 294158 0
Flinders Medical Centre
Address [1] 294158 0
Flinders Drive, Bedford Park 5042 SA
Country [1] 294158 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Flinders Drive, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 292991 0
None
Name [1] 292991 0
Address [1] 292991 0
Country [1] 292991 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295570 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 295570 0
The Flats G5 – Rooms 3 and 4
Flinders Drive
Flinders Medical Centre, Bedford Park SA 5042
Ethics committee country [1] 295570 0
Australia
Date submitted for ethics approval [1] 295570 0
15/09/2016
Approval date [1] 295570 0
19/10/2016
Ethics approval number [1] 295570 0
OFR # 373.16 - HREC/16/SAC/346

Summary
Brief summary
Hyperglycaemia in hospitalised patients is independently associated with increased morbidity and mortality in a wide range of patient groups, including post-operative outcomes. The association between hyperglycaemia and poor post-operative outcomes is strong in patients without diabetes, but a weaker predictor in patients with diabetes.
This discrepancy is in part driven by the difficulty in distinguishing genuine stress hyperglycaemia from chronic high levels seen in diabetic patients. A high plasma glucose concentration in a hospitalised patient can occur because of chronic poor diabetes control and be “normal” for that patient, represent a transient physiologic response to an inter¬current illness (stress hyperglycaemia), or be a combination of the above.
A metric for stress hyperglycaemia has been developed at FMC - the Stress Hyperglycaemia Ratio is defined as glucose concentration divided by the Estimated Average Glucose concentration, which is calculated from HbA1c. This enables quantification of the relative change in hyperglycaemia eg a patient with a SHR of 1.4 has an glucose concentration 40% higher than their average glucose over the prior 3 months.
Our previous work indicated that the relative change in glucose was a better indicator of stress hyperglycaemia and more strongly associated with adverse patient outcomes than glucose.
Patients undergoing CABG surgery require mandatory post-op observation in the ICU setting, and commonly require intervention for glucose management. There is some conjecture that the commonly used glucose control range is no appropriate for all patients. We aim to determine the glucose control range that is associated with the best post-op outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67626 0
Mr Greg Roberts
Address 67626 0
Pharmacy Department
Flinders Medical Centre
Flinders Drive, Bedford Park, SA 5042
Country 67626 0
Australia
Phone 67626 0
+61 8 82046936
Fax 67626 0
+61 8 82046245
Email 67626 0
greg.roberts2@sa.gov.au
Contact person for public queries
Name 67627 0
Mr Greg Roberts
Address 67627 0
Pharmacy Department
Flinders Medical Centre
Flinders Drive, Bedford Park, SA 5042
Country 67627 0
Australia
Phone 67627 0
+61 8 82046936
Fax 67627 0
+61 8 82046245
Email 67627 0
greg.roberts2@sa.gov.au
Contact person for scientific queries
Name 67628 0
Mr Greg Roberts
Address 67628 0
Pharmacy Department
Flinders Medical Centre
Flinders Drive, Bedford Park, SA 5042
Country 67628 0
Australia
Phone 67628 0
+61 8 82046936
Fax 67628 0
+61 8 82046936
Email 67628 0
greg.roberts2@sa.gov.au

No information has been provided regarding IPD availability
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