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Trial registered on ANZCTR


Registration number
ACTRN12615000216516
Ethics application status
Approved
Date submitted
12/02/2015
Date registered
5/03/2015
Date last updated
11/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
An audit of the impact of a change in the blood glucose targets protocol on intensive care mortality for diabetic patients admitted to the intensive care unit
Scientific title
An audit of the impact of a change in the blood glucose targets protocol on intensive care mortality for diabetic patients admitted to the intensive care unit
Secondary ID [1] 286158 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 294164 0
Condition category
Condition code
Metabolic and Endocrine 294493 294493 0 0
Diabetes
Public Health 294564 294564 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
From March 2015 to March 2017 adult patients admitted to the intensive care unit with a medical history of having diabetes will have their blood glucose level target as being between 10.0 to 14.0 mmol per litre.
Intervention code [1] 291164 0
Treatment: Other
Comparator / control treatment
For the 14-month period preceeding the introduction of the change in the blood glucose target protocol for diabetic patients. The target blood glucose level for both non-diabetic and diabetic patients in the intenisve care was clinician preference.
Control group
Historical

Outcomes
Primary outcome [1] 294269 0
Mortality - intensive care
Timepoint [1] 294269 0
Survival status of diabetic patients at the time of their discharge from the intensive care unit.
Primary outcome [2] 294270 0
Mortality - hospital
Timepoint [2] 294270 0
Survival status of diabetic patients at the time of their discharge from the hospital.
Secondary outcome [1] 312914 0
Duration of intensive care unit admission
Timepoint [1] 312914 0
Number of days the patient is admitted to the intensive care unit
Secondary outcome [2] 312915 0
Duration of hospital admission
Timepoint [2] 312915 0
Number of days the patient is admitted to the hospital
Secondary outcome [3] 312916 0
Mechanical ventilation - intensive care unit
Timepoint [3] 312916 0
Duration in hours of mechanical ventilation received by each patient while admitted to the intensive care unit
Secondary outcome [4] 312917 0
Acute kidney injury - intensive care unit
Timepoint [4] 312917 0
Development of acute kidney injury as defined by the Risk, Injury Failure, Loss of function, End-stage renal disease (RIFLE) or Kidney Disease Improving Global Outcomes (KDIGO) criteria while the patient is admitted hospital.
Secondary outcome [5] 312918 0
Delirium - requiring anti-psychotic medication - intensive care unit
Timepoint [5] 312918 0
Patient requirement for anti-psychotic medication while admitted to the intensive care unit
Secondary outcome [6] 312919 0
Serum troponin levels
Timepoint [6] 312919 0
Daily as routinely reported for the duration of the patients admission to hospital
Secondary outcome [7] 312920 0
Hypoglycaemic event - mild (blood glucose equal to or greater than 4.0 to < 6.0 mmol/L) for both assessment periods.
Timepoint [7] 312920 0
Number of hypoglycaemic events - mild - occuring in the intensive care unit
Secondary outcome [8] 312921 0
Hypoglycaemic event - moderate (blood glucose >2.3 to less than or equal to 3.9 mmol/L) for both assessment periods.
Timepoint [8] 312921 0
Number of hypoglycaemic events - moderate - event occurring in the intensive care unit
Secondary outcome [9] 312922 0
Hypoglycaemic event - severe (blood glucose equal to or less than 2.2 mmol/L)
Timepoint [9] 312922 0
Number of hypoglycaemic events - severe - occuring in the intensive care unit
Secondary outcome [10] 312927 0
Mean blood glucose concentrations in mmol/L - all diabetic patients admitted to the intensive care unit
Timepoint [10] 312927 0
24-month period following the introduction of the protocol change of blood glucose target.
Secondary outcome [11] 327501 0
Serum ketone levels
Timepoint [11] 327501 0
Daily as routinely reported for the duration of the patient's admission to the intensive care unit
Secondary outcome [12] 327502 0
Serum C-peptide levels
Timepoint [12] 327502 0
Daily as routinely reported for the duration of the patient's admission to the intensive care unit.
Secondary outcome [13] 327503 0
Insulin administration assessed via medical record review.
Timepoint [13] 327503 0
Daily as routinely documented for the duration of the patient's admission to the intensive care unit.
Secondary outcome [14] 327504 0
Empagliflozin administration assessed via medical record review.
Timepoint [14] 327504 0
Daily as routinely recorded for the duration of the patient's admission to hospital
Secondary outcome [15] 337811 0
Anti-delirium medicine (e.g. quetiapine, haloperidol, demedetomidine, clonidine) administration assessed via medical record review
Timepoint [15] 337811 0
Daily as routinely recorded for the duration of hte patient's admission
Secondary outcome [16] 337812 0
Microbiology positive result from all of the following together, blood culture sample, trachael aspirate via an endotrachael tube, urinary sample obtained from an indwelling urinary catheter, cerebrospinal fluid sample and pleural effusion drainage sample assessed via medical record review.
Timepoint [16] 337812 0
Daily as routinely recorded for the duration of the patients' admission to hospital.
Secondary outcome [17] 337813 0
Number of episodes of "relative hypoglycemia" defined as a blood glucose level 30% below the patient's premorbid estimated average glucose concentration determined via analysis of the blood glucose results via medical record review.
Timepoint [17] 337813 0
Daily as routinely reported for the duration of the patient's admission to hospital

Eligibility
Key inclusion criteria
Adult patients admitted to the intensive care unit with a medical diagnosis of diabetes
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Convenience sampling
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
With 350 patients in each group We have a>95% power to see an increase in glucose levels of 2mmmol/L with liberal glucose control, assuming a control (before) level of 9 mmol/L with a standard deviation of 5 mmol/L at an alpha of 0.05.

Baseline comparisons will be performed using Fisher’s exact tests and reported as n (%). Continuous normally distributed variables will be compared using Student t-tests and reported as means (standard deviation), while non-normally distributed data will be compared using Wilcoxon rank-sum tests and reported as medians [interquartile range]. Changes over time will be determined using repeated measures mixed linear modeling with each patient treated as a random effect, and therapy group, time and the interaction of therapy group and time as effect fixed effects. All analysis will be performed by using SPSS version 19.0 (SPSS Inc, Chicago, IL, USA).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2015
Actual
1/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
700
Accrual to date
350
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3439 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 9207 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 290730 0
Hospital
Name [1] 290730 0
Austin Health
Country [1] 290730 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg VIC 3084
Country
New Zealand
Secondary sponsor category [1] 289420 0
Individual
Name [1] 289420 0
Professor Rinaldo Bellomo
Director, Intensive Care Research
Address [1] 289420 0
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country [1] 289420 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292367 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 292367 0
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Ethics committee country [1] 292367 0
Australia
Date submitted for ethics approval [1] 292367 0
19/09/2014
Approval date [1] 292367 0
18/11/2014
Ethics approval number [1] 292367 0
LNR/14/Austin/487

Summary
Brief summary
Many people with type-1 and type-2 diabetes develop critical illness, which inevitably leads to deterioration in glycaemic control. However, most critically ill patients with hyperglycaemia are not diabetic, but develop disordered glucose metabolism that normalises once the acute illness resolves – so-called critical-illness induced hyperglycaemia (CIIH). While a number of studies have evaluated the effects of modulating glycaemia, using insulin, on outcomes in the critically ill, a major limitation of these studies, given recent information, is that critically ill patients with hyperglycaemia have been considered a homogenous cohort, rather than classifying hyperglycaemia in the critically ill according to pre-morbid glycaemia or presence of diabetes.

Recent data indicate that a paradigm shift is required, and that patients with CIIH should be considered separately to those critically ill patients known to have diabetes, particularly those patients with ‘chronic’ hyperglycaemia, or ‘poorly controlled’ diabetes. Given these data (and that it intuitively makes sense) the medical staff at Austin Hospital Intensive Care Unit believe we should be personalising blood glucose targets and that, in diabetic patients, the target glucose level in ICU should simulate the sort of glycemic levels these patients are likely to commonly experience in their daily lives, especially during situations of physiological stress (between 10-14 mmol/L). Such target glucose level would also be expected to prevent any episodes of even mild hypoglycaemia, which have been associated with increased risk of death.

However, allowing slightly increased blood glucose concentrations in critically ill patients known to have diabetes is a slight change from current practice, and evidence to support this change, although logical and strong, is from observational studies only.

Accordingly, we wish to collect data after the implementation of the new protocol to audit the effects of glycaemia on outcomes and ensure that this protocol proves safe and does indeed prevent hypoglycemic episodes as expected.

This audit represents a formal assessment of a quality improvement initiative dedicated at increasing the quality of glycaemic care in critically ill diabetic patients.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 309 309 0 0
/AnzctrAttachments/367950-LNR14Austin487(full approval)5's LNRR application single site - APPROVED after changes template v2 July 2014.pdf (Ethics approval)
Attachments [2] 1095 1095 0 0
/AnzctrAttachments/367950(v25-08-2016-14-44-44)-LNR14Austin487(full approval)5's LNRR application single site - APPROVED after changes template v2 July 2014.pdf (Ethics approval)
Attachments [3] 1096 1096 0 0
/AnzctrAttachments/367950-20160817 LETTER LNR14Austin487 Ethics Amendment Approval.pdf (Ethics approval)
Attachments [4] 1964 1964 0 0
/AnzctrAttachments/367950-20170512 LETTER LNR14Austin487 Ethics Amendment Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 54858 0
Prof Rinaldo Bellomo
Address 54858 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 54858 0
Australia
Phone 54858 0
+61 3 9496 5992
Fax 54858 0
+61 3 9496 3932
Email 54858 0
rinaldo.bellomo@austin.org.au
Contact person for public queries
Name 54859 0
A/Prof Glenn Eastwood
Address 54859 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 54859 0
Australia
Phone 54859 0
+61 3 9496 4835
Fax 54859 0
+61 3 9496 3932
Email 54859 0
glenn.eastwood@austin.org.au
Contact person for scientific queries
Name 54860 0
Prof Rinaldo Bellomo
Address 54860 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 54860 0
Australia
Phone 54860 0
+61 3 9496 5992
Fax 54860 0
+61 3 9496 3932
Email 54860 0
rinaldo.bellomo@austin.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLiberal glucose control in ICU patients with diabetes: A before-and-after study.2018https://dx.doi.org/10.1097/CCM.0000000000003087
EmbaseThe effect of insulin administration on c-peptide in critically ill patients with type 2 diabetes.2017https://dx.doi.org/10.1186/s13613-017-0274-5
EmbasePrevalence of ketosis, ketonuria, and ketoacidosis during liberal glycemic control in critically ill patients with diabetes: an observational study.2016https://dx.doi.org/10.1186/s13054-016-1462-7
N.B. These documents automatically identified may not have been verified by the study sponsor.