ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001295336

Ethics application status

Approved

Date submitted

31/08/2017

Date registered

7/09/2017

Date last updated

9/08/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

The relationship between hospital outcomes and increased sugar levels due to illness (stress hyperglycaemia) using a new marker called the Stress Hyperglycaemia Ratio

Scientific title

Stress hyperglycaemia and hospital outcomes in acutely hospitalised patients as determined by the Stress Hyperglycaemia Ratio

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Stress hyperglycaemia

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

The association of stress hyperglycaemia with adverse outcomes associated with hospitalisations will be determined using admission glucose level, and the relative change in glucose at admission as determined by the Stress Hyperglycaemia Ratio. SHR is defined by glucose value closest to the time of admission 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. An adverse outcome is in-hospital death or the acute need for critical care, with patients being observed for the duration of the inpatient admission for the main endpoint, and up to 30 days post-discharge for the secondary endpoints. The strength of association of adverse outcomes will be compared in a multivariable model using admission glucose and admission Stress Hyperglycaemia Ratio, along with other variables known to impact outcomes.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

The association of outcomes with glucose levels will act as the conventional control group. The patient cohort will be selected from patients admitted to hospital over the period 21/1/2013 to 25/7/2017 identified using hospital casemix (ICD10) databases.

Control group

Historical

Outcomes

Primary outcome [1]

The composite outcome of in-hospital death or the acute need for critical care from the point of hospital admission until hospital discharge, using administrative hospital data (International Code of Diseases classification).

Timepoint [1]

The time of admission until the time of hospital discharge.

Secondary outcome [1]

The development of new infection from the point of admission until 30 days after hospital discharge, excluding the initial primary admission diagnosis, as determined by casemix ICD10 coding and hospital records.

Timepoint [1]

The time of admission until 30 days post-discharge.

Secondary outcome [2]

The development of any new thrombus-related event (embolic stroke, MI, DVT, PE) from the point of admission until 30 days post-discharge, excluding the initial primary admission diagnosis as determined by casemix ICD10 coding and hospital records.

Timepoint [2]

The time of admission until 30 days post-discharge.

Secondary outcome [3]

In-hospital mortality as determined by hospital databases (ICD10 casemix coding).

Timepoint [3]

The time of admission until the time of hospital discharge.

Secondary outcome [4]

The need for critical care during hospitalisation, as identified by hospital databases (ICD10 casemix coding).

Timepoint [4]

Time of admission to time of discharge

Eligibility

Key inclusion criteria

Inpatient admission

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

<18 years age, admissions for psychiatric illness, obstetrics, gynaecology, specific management of blood glucose eg diabetic ketoacidosis, overdose, poisoning, dialysis, non-acute admissions for respite, chemotherapy, patients requiring routine post-op care in ICU.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Convenience sample

Timing

Retrospective

Statistical methods / analysis

Statistical power: Our previous work demonstrated a superior association between the Stress Hyperglycaemia Ratio and absolute glucose levels with a sample size of 2290 patients. The current database is expected to yield 7000 patients and will be should be well-powered to reproduce this association if it is present.
Variables of interest (glucose, SHR, age, haemoglobin, gender, renal function, ethnicity), will be subject to multivariable regression analysis to determine the association with adverse outcomes.
Locally Weighted Scatterplot Smoothing will be used to explore the relationship between patients with (HbA1c>=6.5%) or without (HbA1c<6.5%) pre-existing chronic background hyperglycaemia.
Subgroup analysis of patients with mean glucose <10mmol/L will be made to determine existence of clinically significant stress hyperglycaemia at glucose levels conventionally considered clinically insignificant.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

7/09/2017

Actual

7/09/2017

Date of last participant enrolment

Anticipated

7/11/2017

Actual

15/02/2018

Date of last data collection

Anticipated

7/11/2017

Actual

20/07/2018

Sample size

Target

5000

Accrual to date

Final

5048

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Flinders Medical Centre - Bedford Park

Recruitment postcode(s) [1]

5042 - Bedford Park

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Flinders Medical Centre

Address [1]

Flinders Drive, Bedford Park SA 5042

Country [1]

Australia

Primary sponsor type

Hospital

Name

Flinders Medical Centre

Address

Flinders Drive, Bedford Park SA 5042

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

Flinders Medical Centre
Flinders Drive
Bedford Park, SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/12/2016

Approval date [1]

27/02/2017

Ethics approval number [1]

OFR # 475.16 - HREC/16/SAC/490

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  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 Flinders Medical Centre - 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. This initial work needs to be confirmed in a further population of hospitalised patients. We also aim to study some specific subgroups of interest, namely infections (both at admission and those that develop during the admission), and events related to blood clots (heart attacks, stroke, deep vein thromboses, and pulmonary emboli). This will enable us to determine those patients who might benefit most from early management of elevated glucose levels due to stress hyperglycaemia.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Greg Roberts

Address

Pharmacy Department
Flinders Medical Centre
Flinders Drive, Bedford Park, SA 5042

Country

Australia

Phone

+61 8 82046936

Fax

+61 8 82046245

greg.roberts2@sa.gov.au

Contact person for public queries

Name

Greg Roberts

Address

Pharmacy Department
Flinders Medical Centre
Flinders Drive, Bedford Park, SA 5042

Country

Australia

Phone

+61 8 82046936

Fax

+61 8 82046245

greg.roberts2@sa.gov.au

Contact person for scientific queries

Name

Greg Roberts

Address

Pharmacy Department
Flinders Medical Centre
Flinders Drive, Bedford Park, SA 5042

Country

Australia

Phone

+61 8 82046936

Fax

+61 8 82046245

greg.roberts2@sa.gov.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

No additional documents have been identified.

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