Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001165279
Ethics application status
Approved
Date submitted
11/07/2018
Date registered
13/07/2018
Date last updated
15/03/2021
Date data sharing statement initially provided
15/03/2021
Date results information initially provided
15/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Thiamine deficiency in patients admitted to intensive care with sepsis and septic shock
Scientific title
Thiamine deficiency in patients admitted to intensive caRe with sEpsis and Septic Shock (TRESS): A Prospective Epidemiological Pilot Study
Secondary ID [1] 295506 0
None
Universal Trial Number (UTN)
Trial acronym
TRESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 308771 0
Septic shock 308772 0
Condition category
Condition code
Infection 307708 307708 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
4
Target follow-up type
Weeks
Description of intervention(s) / exposure
Patients exposed to sepsis or septic shock will be monitored for thiamine deficiency. Therefore transketolase levels will be measured at 4 timepoints to determine (relative) thiamine deficiency. Also lactate levels will be observed in each patient, to review any relationship between thiamine deficiency and lactate levels.
Intervention code [1] 301827 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306699 0
Thiamine deficiency, assessed by transketolase levels in blood samples
Timepoint [1] 306699 0
timepoints of blood draws:
1) at or shortly after ICU admission
2) 24 hours after ICU admission [primary timepoint]
3) 48 hours after ICU admission
4) 72 hours after ICU admission
Secondary outcome [1] 349291 0
Lactate level, obtained by arterial blood draw
Timepoint [1] 349291 0
Timepoints for lactate measurements will be:
1) at or shortly after ICU admission
2) 24 hours after ICU admission
3) 48 hours after ICU admission
4) 72 hours after ICU admission

Eligibility
Key inclusion criteria
Sepsis, defined as an infection complicated by organ dysfunction, identified as SOFA score greater than or equal to 2 or a change in SOFA greater than or equal to 2 point from baseline,
OR
Septic shock, defined as sepsis and persistent hypotension despite adequate fluid resuscitation, as seen by:
1. Vasopressors required to maintain MAP greater than or equal to 65 mmHg
AND
2. Serum lactate level greater than 2 mmol/L
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
<18 years of age;
Pregnancy;
Liver cirrhosis;
Thiamine supplementation commenced, in the institution, prior to, or within 24 hours of ICU admission.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Individual variables will be summarised by mean (SD), median (IQR) or count (%) as indicated. Thiamine levels will be reported as absolute levels at measured time points, and as relative change in concentration across the 72 hour period. Univariate analysis will be conducted to measure association between thiamine concentration, physiological variables and lactate concentrations, with statistically significant results being used to conduct multivariate analysis. Statistical analysis will be performed using SPSS 24 and/or StataMP 15 software.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/07/2018
Actual
19/07/2018
Date of last participant enrolment
Anticipated
1/11/2018
Actual
13/09/2018
Date of last data collection
Anticipated
5/11/2018
Actual
16/09/2018
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 11409 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 23322 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 300091 0
Hospital
Name [1] 300091 0
ICU research, in kind Royal Adelaide Hospital
Country [1] 300091 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Port Rd, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 299492 0
None
Name [1] 299492 0
Address [1] 299492 0
Country [1] 299492 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300938 0
Central Adelaide local health network Human research ethics committee
Ethics committee address [1] 300938 0
L3, Roma Mitchell House, North Terrace, Adelaide – Postal Details: RAH Clinical Trial Centre, Wayfinder 3D460.02, Level 3, Royal Adelaide Hospital, Port Road, ADELAIDE SA 5000
Ethics committee country [1] 300938 0
Australia
Date submitted for ethics approval [1] 300938 0
18/04/2018
Approval date [1] 300938 0
31/05/2018
Ethics approval number [1] 300938 0
R20180415

Summary
Brief summary
This study will determine the prevalence and incidence of thiamine deficiency in patients admitted to the intensive care unit with sepsis and septic shock, and measure association with peak lactate concentrations at admission, and within 24, 48 and 72 hours of admission.
As a pilot epidemiological study, this project will help inform future studies of the role of thiamine and other nutritional deficiencies in the pathogenesis and management of septic shock, and will provide useful data for hypothesis generation and calculation of sample size for future studies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85346 0
Dr Eamon Raith
Address 85346 0
ICU research
Royal Adelaide Hospital
Port Rd, Adelaide SA 5000
Country 85346 0
Australia
Phone 85346 0
+61 (0)870741759
Fax 85346 0
Email 85346 0
[email protected]
Contact person for public queries
Name 85347 0
Ms Stephanie O'Connor
Address 85347 0
ICU research
Royal Adelaide Hospital
Port Rd, Adelaide SA 5000
Country 85347 0
Australia
Phone 85347 0
+61 (0)8 7074 1781
Fax 85347 0
Email 85347 0
[email protected]
Contact person for scientific queries
Name 85348 0
Dr Eamon Raith
Address 85348 0
ICU research
Royal Adelaide Hospital
Port Rd, Adelaide SA 5000
Country 85348 0
Australia
Phone 85348 0
+61 (0)870741759
Fax 85348 0
Email 85348 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.