Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001127291
Ethics application status
Approved
Date submitted
3/07/2018
Date registered
10/07/2018
Date last updated
17/08/2022
Date data sharing statement initially provided
17/08/2022
Date results information initially provided
17/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Skin Failure in the Critically ill.
Scientific title
Microcirculatory Dysfunction and Skin Failure in Critically ill patients: An exploratory study.
Secondary ID [1] 295410 0
nil known
Universal Trial Number (UTN)
Trial acronym
SoFIa
Linked study record

Health condition
Health condition(s) or problem(s) studied:
skin failure 308640 0
skin microcirculatory dysfunction 308641 0
Condition category
Condition code
Skin 307585 307585 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patient suitability will be confirmed within 18 hours of patient admission, with the registered nurse (RN) assigned to the patient, Clinical Nurse Consultant (CNC), the team leader (usually the CNC), Clinical Co-ordinator (CC) and medical staff member allocated to the patient. A suitable time for data collection will be co-ordinated with relevant staff members of the ICU department. The research nurse will then discuss the Patient Information and Consent (PICF) form with the person responsible at the bedside (if available) and include the patient, regardless of the patient’s conscious state, gaining consent from the person responsible for the patient. When data collecting, the research nurse will talk to the patient throughout the study procedures, regardless of conscious state (this is standard professional practice).

When the patient is scheduled for repositioning the research nurse will set up the imaging equipment at the patient bedside. Participants will be studied in bed. Incidental Dark Field (IDF) imaging will be conducted prior to repositioning, while the patient is supine. The research nurse will place the IDF probe sublingually in 3 different locations under the tongue, as per the diagram within the case report form (CRF), holding the probe in each position for 30 seconds. The patient will then be assisted by the nursing and patient support officer onto their side to facilitate Laser Speckle Contrast Imaging (LSCI). This will be carried out discreetly and patient privacy and dignity will be maintained at all times. The research nurse will have the LSCI set up at the patient bedside prior to patient repositioning so once the patient is comfortable on their side the recording will take place. Once the patient is lying in position and the LSCI recording has started, the patient will remain in the position for 2-5mins. Finally, a 30 second sub epidermal moisture (SEM) scan will occur once LSCI is complete. Following study measure completion the bedside nurse and patient support officer will complete their reposition tasks.

Blood sampling for the analysis of Syndecan-1 (SDC-1) and soluble thrombomodulin (sTM) will utilise two ml of plasma, which would otherwise be discarded, from all blood samples collected during the course of the patients ICU hospital admission, up until intensive care discharge. These samples will be aliquoted into four Eppendorf tubes and frozen at -80 C by Pathology Queensland laboratory staff. Laboratory staff will be notified which blood sampled will be collected via a phone call and pathology slip.

The SDC-1 and sTM analysis will be conducted by Queensland pathology. Each sample will be measured in duplicate from the defrosted samples using a commercially available enzyme-linked immunosorbent assay (ELISA) kit once study recruit is complete. Any unused plasma will be discarded after five years of storage. Due to plasma samples being batch-processed outside of a clinically relevant timeframe, and clinicians not being advised of the results, there is no risk that patient care will be altered by the results of this testing.

All observation and blood data collected will be obtained from Metavision, accessed by QLD health employed research staff only.

Screening visit/Day of Enrolment
The following processes will occur during the screening visit:
• Signed informed consent form (document attempts to obtain consent)
• Record participant demographics
• Data collection
On subsequent data collection days the following processes will occur:
Day 1
• Signed informed consent form (document attempts to obtain consent)
• Data collection
• Incidental Dark Field imaging/ Laser Speckle Contrast Imaging
• Adverse events notification
Day 2
• Signed informed consent form (document attempts to obtain consent)
• Data collection
• Adverse events notification
Day 3
• Signed informed consent form (document attempts to obtain consent)
• Data collection
• Incidental Dark Field imaging/ Laser Speckle Contrast Imaging
• Adverse events notification
Day 4
• Signed informed consent form (document attempts to obtain consent)
• Data collection
• Adverse events notification
Day 5
• Signed informed consent form (document attempts to obtain consent)
• Data collection
• Incidental Dark Field imaging/ Laser Speckle Contrast Imaging
• Adverse events notification
Day 6
• Signed informed consent form (document attempts to obtain consent)
• Data collection
• Adverse events notification

When participants’ admission to ICU is greater than 6 days, the study visits and procedures will be repeated once a week up to three weeks.


Intervention code [1] 301719 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306566 0
Composite outcome: Changes in perfusion at a cellular, microvascular and macrovascular levels measured by:
• High levels of Syndecan-1 and soluble thrombomodulin in blood analysis, indicative widespread endothelial glycocalyx shedding and endothelial cell compromise.
• Global microcirculatory blood flow changes via Incidental Dark Field imaging.
• Local cutaneous blood flow changes at the sacrum and heels via Laser Speckle Contrast Imaging.
• Macrovascular changes though the assessment of bedside haemodynamic measures.
Timepoint [1] 306566 0
daily for up to 6 days (primary endpoint) and then weekly for up to 3 weeks
Secondary outcome [1] 348890 0
Mortality – all-cause 28 day mortality.
Timepoint [1] 348890 0
28 days
Secondary outcome [2] 349062 0
Pressure injury (PI) development, any stage, severity and time to occurrence.
Timepoint [2] 349062 0
for duration of ICU admission
Secondary outcome [3] 349063 0
Development of skin failure (as diagnosed by skin integrity services [specialist wound care RN’s])
Timepoint [3] 349063 0
for duration of ICU stay.

Eligibility
Key inclusion criteria
• Intubated and mechanically ventilated.
• 18 years old and over.
• Expected length of ICU stay greater than 6 days. (length of stay 6 days and greater and known to increase the risk of skin breakdown in ICU patient)
• SEM scanner score greater than or equal to 0.5
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant Women (Pregnant women have extremely high levels of SDC-1 for unknown reasons related to pregnancy that do not appear to be due to widespread EG shedding in the mother)
• Imminent Death
• Physiological condition prohibiting side positioning e.g. spinal injuries.
• Skin conditions at perfusion measurement sites e.g. burns
• Community acquired skin breakdown
• Droplet precautions

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Statistical analyses will be undertaken using a propriety statistical package SPSS (version 25). Descriptive data will be analysed using frequencies, means as percentages as appropriate for continuous and categorical variables. Relationships between variables (both within and between subgroups) will be examined using a mixed effects model (ANOVA). Feasibly of the study will be described in terms of numbers of patients for screening, recruitment and enrolment.

Kaplan-Meier survival analysis will be used to compare time to new skin breakdown events. Chi square test of independence will be used to determine differences in skin breakdown using PI stages and to determine differences in process of care practices delivered. To accommodate cluster effects, logistic regression analysis will be used to adjust for confounders.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2018
Actual
1/08/2019
Date of last participant enrolment
Anticipated
1/08/2019
Actual
30/11/2019
Date of last data collection
Anticipated
1/09/2019
Actual
5/12/2019
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11302 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 23200 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 299997 0
Hospital
Name [1] 299997 0
Royal Brisbane and Womens Hospital
Country [1] 299997 0
Australia
Funding source category [2] 300000 0
University
Name [2] 300000 0
Queensland University of Technology
Country [2] 300000 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Womens Hospital
Address
The Royal Brisbane and Women’s Hospital
Level 4, Ned Hanlon Building,
Bowen Bridge Road &, Butterfield St,
Herston, Qld, 4029
Country
Australia
Secondary sponsor category [1] 299384 0
None
Name [1] 299384 0
Address [1] 299384 0
Country [1] 299384 0
Other collaborator category [1] 280217 0
University
Name [1] 280217 0
Queensland University of Technology
Address [1] 280217 0
School Of Nursing, Queensland University of Technology,
Room B601, Level 6, O Block, B Wing,
Ring Road, Kelvin Grove QLD 4059
Country [1] 280217 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300852 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 300852 0
The Prince Charles Hospital Building 14 Rode Road, Chermside QLD 4032
Ethics committee country [1] 300852 0
Australia
Date submitted for ethics approval [1] 300852 0
13/06/2018
Approval date [1] 300852 0
06/07/2018
Ethics approval number [1] 300852 0
HREC/18/QPCH/232

Summary
Brief summary
Title
Microcirculatory DySfunction and Skin Failure in Critically Ill patients: An exploratory study. (SoFIa Study)

Aim
To explore skin microvascular and macrovascular changes in critically ill patients.

Study Design
Quantitative, prospective, observational, exploratory design.

Planned Sample Size
30 ICU patients meeting the selection criteria.

Selection Criteria
Inclusion Criteria
• Intubated and mechanically ventilated.
• 18 years old and over.
• Expected length of ICU stay greater than 6 days.
• SEM scanner score greater than or equal to 0.5

Exclusion Criteria
• Pregnant Women
• Imminent Death
• Physiological condition prohibiting side positioning e.g. spinal injuries.
• Skin conditions at perfusion measurement sites e.g. burns
• Community acquired skin breakdown
• Droplet precautions

Outcome Measures
Primary outcome measure
Changes in perfusion at a cellular, microvascular and macrovascular levels measured by:
• High levels of Syndecan-1 and soluble thrombomodulin in blood analysis, indicative widespread endothelial glycocalyx shedding and endothelial cell compromise.
• Global microcirculatory blood flow changes via Incidental Dark Field imaging.
• Local cutaneous blood flow changes at the sacrum and heels via Laser Speckle Contrast Imaging.
• Macrovascular changes though the assessment of bedside haemodynamic measures.

Statistical Analysis Plan
Descriptive data will be analysed using frequencies, means as percentages as appropriate for continuous and categorical variables. Relationships between variables will be examined using a mixed effects model.
Kaplan-Meier survival analysis will be used to compare time to new skin breakdown events.
Duration of the study Commencement date – 21 August 2019;
Completion date – 07 November 2019.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85034 0
Miss Lizanne Dalgleish
Address 85034 0
The Royal Brisbane and Women’s Hospital
Department of Anaesthetics,
Level 4 Ned Hanlon Building,
Bowen Bridge Road &, Butterfield St,
Herston QLD 4029
Country 85034 0
Australia
Phone 85034 0
+61 7 3646 6811
Fax 85034 0
Email 85034 0
[email protected]
Contact person for public queries
Name 85035 0
Miss Lizanne Dalgleish
Address 85035 0
The Royal Brisbane and Women’s Hospital
Department of Anaesthetics,
Level 4 Ned Hanlon Building,
Bowen Bridge Road &, Butterfield St,
Herston QLD 4029
Country 85035 0
Australia
Phone 85035 0
+61 7 3646 6811
Fax 85035 0
Email 85035 0
[email protected]
Contact person for scientific queries
Name 85036 0
Miss Lizanne Dalgleish
Address 85036 0
The Royal Brisbane and Women’s Hospital
Department of Anaesthetics,
Level 4 Ned Hanlon Building,
Bowen Bridge Road &, Butterfield St,
Herston QLD 4029
Country 85036 0
Australia
Phone 85036 0
+61 7 3646 6811
Fax 85036 0
Email 85036 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
Ethical approval for this has not been sort.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo 1. the number of days a patient had been admitted ... [More Details]

Documents added automatically
No additional documents have been identified.