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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetes

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Public Health

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]

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]

Mortality - intensive care

Timepoint [1]

Survival status of diabetic patients at the time of their discharge from the intensive care unit.

Primary outcome [2]

Mortality - hospital

Timepoint [2]

Survival status of diabetic patients at the time of their discharge from the hospital.

Secondary outcome [1]

Duration of intensive care unit admission

Timepoint [1]

Number of days the patient is admitted to the intensive care unit

Secondary outcome [2]

Duration of hospital admission

Timepoint [2]

Number of days the patient is admitted to the hospital

Secondary outcome [3]

Mechanical ventilation - intensive care unit

Timepoint [3]

Duration in hours of mechanical ventilation received by each patient while admitted to the intensive care unit

Secondary outcome [4]

Acute kidney injury - intensive care unit

Timepoint [4]

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]

Delirium - requiring anti-psychotic medication - intensive care unit

Timepoint [5]

Patient requirement for anti-psychotic medication while admitted to the intensive care unit

Secondary outcome [6]

Serum troponin levels

Timepoint [6]

Daily as routinely reported for the duration of the patients admission to hospital

Secondary outcome [7]

Hypoglycaemic event - mild (blood glucose equal to or greater than 4.0 to < 6.0 mmol/L) for both assessment periods.

Timepoint [7]

Number of hypoglycaemic events - mild - occuring in the intensive care unit

Secondary outcome [8]

Hypoglycaemic event - moderate (blood glucose >2.3 to less than or equal to 3.9 mmol/L) for both assessment periods.

Timepoint [8]

Number of hypoglycaemic events - moderate - event occurring in the intensive care unit

Secondary outcome [9]

Hypoglycaemic event - severe (blood glucose equal to or less than 2.2 mmol/L)

Timepoint [9]

Number of hypoglycaemic events - severe - occuring in the intensive care unit

Secondary outcome [10]

Mean blood glucose concentrations in mmol/L - all diabetic patients admitted to the intensive care unit

Timepoint [10]

24-month period following the introduction of the protocol change of blood glucose target.

Secondary outcome [11]

Serum ketone levels

Timepoint [11]

Daily as routinely reported for the duration of the patient's admission to the intensive care unit

Secondary outcome [12]

Serum C-peptide levels

Timepoint [12]

Daily as routinely reported for the duration of the patient's admission to the intensive care unit.

Secondary outcome [13]

Insulin administration assessed via medical record review.

Timepoint [13]

Daily as routinely documented for the duration of the patient's admission to the intensive care unit.

Secondary outcome [14]

Empagliflozin administration assessed via medical record review.

Timepoint [14]

Daily as routinely recorded for the duration of the patient's admission to hospital

Secondary outcome [15]

Anti-delirium medicine (e.g. quetiapine, haloperidol, demedetomidine, clonidine) administration assessed via medical record review

Timepoint [15]

Daily as routinely recorded for the duration of hte patient's admission

Secondary outcome [16]

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]

Daily as routinely recorded for the duration of the patients' admission to hospital.

Secondary outcome [17]

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]

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?

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]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Health

Address [1]

145 Studley Road
Heidelberg VIC 3084

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

145 Studley Road
Heidelberg VIC 3084

Country

New Zealand

Secondary sponsor category [1]

Individual

Name [1]

Professor Rinaldo Bellomo
Director, Intensive Care Research

Address [1]

Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/09/2014

Approval date [1]

18/11/2014

Ethics approval number [1]

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]

/AnzctrAttachments/367950-LNR14Austin487(full approval)5's LNRR application single site - APPROVED after changes template v2 July 2014.pdf (Ethics approval)

Attachments [2]

/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]

/AnzctrAttachments/367950-20160817 LETTER LNR14Austin487 Ethics Amendment Approval.pdf (Ethics approval)

Attachments [4]

/AnzctrAttachments/367950-20170512 LETTER LNR14Austin487 Ethics Amendment Approval.pdf (Ethics approval)

Contacts

Principal investigator

Name

Prof Rinaldo Bellomo

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 5992

Fax

+61 3 9496 3932

rinaldo.bellomo@austin.org.au

Contact person for public queries

Name

Glenn Eastwood

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 4835

Fax

+61 3 9496 3932

glenn.eastwood@austin.org.au

Contact person for scientific queries

Name

Rinaldo Bellomo

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 5992

Fax

+61 3 9496 3932

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

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
5289	Study results article	Yes	https://doi.org/10.1097/CCM.0000000000003087	Luethi, Nora MD1; Cioccari, Luca MD1; Biesenbach, ... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Prevalence of ketosis, ketonuria, and ketoacidosis during liberal glycemic control in critically ill patients with diabetes: an observational study.	2016	https://dx.doi.org/10.1186/s13054-016-1462-7
Embase	The effect of insulin administration on c-peptide in critically ill patients with type 2 diabetes.	2017	https://dx.doi.org/10.1186/s13613-017-0274-5
Embase	Liberal glucose control in ICU patients with diabetes: A before-and-after study.	2018	https://dx.doi.org/10.1097/CCM.0000000000003087

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically