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Trial registered on ANZCTR


Registration number
ACTRN12623000112662
Ethics application status
Approved
Date submitted
20/01/2023
Date registered
1/02/2023
Date last updated
1/05/2024
Date data sharing statement initially provided
1/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Early versus delayed aperient use in the intensive care unit
Scientific title
A cluster double crossover trial of early versus delayed aperient use on the incidence of diarrhoea during intensive care unit admission in mechanically ventilated enterally fed patients
Secondary ID [1] 308806 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel management in intensive care 328758 0
Condition category
Condition code
Oral and Gastrointestinal 325767 325767 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early aperient use in which aperient administration commences at day 1 of enteral feed starting.
The treatment is for one oral coloxyl with senna (Docusate sodium 50 mg / Sennosides 8 mg) tablet twice daily, starting the day that enteral nutrition was commenced and continued daily while enteral nutrition continues or until the development of diarrhoea while in the patient is in the intensive care unit. If no bowel action occurred by day 5 lactulose will be commenced at 20 ml twice daily via the nasogastic tube while the patient is in the intensive care unit. Medical record audit will be performed via members of the intensive care unit research team to monitor compliance.
Intervention code [1] 325255 0
Treatment: Drugs
Comparator / control treatment
Delayed aperient use in which aperient administration commences at day 6 of enteral feed starting. The treatment is for no laxatives are to be administered until day 6 of enteral nutrition, when one coloxyl with senna (Docusate sodium 50 mg / Sennosides 8 mg) tablet twice daily will be commenced and administered daily while enteral nutrition continues or until the development of diarrhoea while in the patient is in the intensive care unit. Medical record audit will be performed via members of the intensive care unit research team to monitor compliance.
Control group
Active

Outcomes
Primary outcome [1] 333609 0
Diarrhoea
Timepoint [1] 333609 0
Documented episodes of diarrhoea occurring during a patient's entire admission to the intensive care unit as recorded in the electronic medical record.
Secondary outcome [1] 417737 0
Insertion of a bowel management device
Timepoint [1] 417737 0
Documented episodes of the insertion of a bowel management device as a result of within-Intensive Care Unit diarrhoea occurring during a patient's entire admission to the intensive care unit as recorded in the electronic medical record.
Secondary outcome [2] 417738 0
Days with diarrhoea
Timepoint [2] 417738 0
Documented days on which episodes of diarrhoea occur during a patient's entire admission to the intensive care unit as recorded in the electronic medical record.
Secondary outcome [3] 417739 0
Development of a paralytic ileus
Timepoint [3] 417739 0
Documented incidence of the development of a paralytic ileus occurring during a patient's entire admission to the intensive care unit as recorded in the electronic medical record.
Secondary outcome [4] 417740 0
Development of a bowel obstruction
Timepoint [4] 417740 0
Documented incidence of the development of a bowel obstruction occurring during a patient's entire admission to the intensive care unit as recorded in the electronic medical record.
Secondary outcome [5] 417741 0
ICD-10 notation of constipation
Timepoint [5] 417741 0
Documented ICD-10 coding of constipation as a complication that occurs during the period of intensive care unit admission through until hospital discharge as recorded in the electronic medical record.
Secondary outcome [6] 417742 0
Days admitted to the intensive care unit
Timepoint [6] 417742 0
Total number of days the patient is admitted to the intensive care unit during their the period of intensive care unit admission through until hospital discharge as recorded in the electronic medical record
Secondary outcome [7] 417743 0
Days admitted to hospital
Timepoint [7] 417743 0
Total number of days the patient is admitted to the hospital during their entire period of hospitalisation as recorded in the electronic medical record
Secondary outcome [8] 417744 0
30-day mortality
Timepoint [8] 417744 0
The mortality status of patients at 30-day after admission to the intensive care unit as recorded in the electronic medical record.

Eligibility
Key inclusion criteria
Adults aged equal to or greater than 18 years
Mechanically ventilated at any stage during the intensive care unit admission
Enterally fed via a feeding tube
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Aged 17 years or younger
Life expectancy less than 24 hours
Receiving palliative care
Primary reason for intensive care admission is a gastrointestinal pathology, gastrointestinal surgery, diarrhoea, constipation, spinal injury
Patient has or is at risk of hepatic encephalopathy requiring lactulose
Patient has existing extensive abdominopelvic debridement, plastic or muscle flaps
Patients at the time of screening for eligibility are receiving extra-corporeal membrane oxygenation (ECMO) therapy or prone ventilation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
20/02/2023
Date of last participant enrolment
Anticipated
29/02/2024
Actual
4/03/2024
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
880
Accrual to date
Final
204
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23859 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 39318 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 313021 0
Hospital
Name [1] 313021 0
Austin Health
Country [1] 313021 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 314709 0
Individual
Name [1] 314709 0
Dr Heidi Gaulke
Address [1] 314709 0
Manager, Office for Research
Austin Health
145 Studley Road
Heidelberg
Victoria 3084
Country [1] 314709 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312284 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 312284 0
145 Studley Road
Heidelberg
Victoria 3084
Ethics committee country [1] 312284 0
Australia
Date submitted for ethics approval [1] 312284 0
07/11/2022
Approval date [1] 312284 0
19/01/2023
Ethics approval number [1] 312284 0
HREC/91317/Austin-2022

Summary
Brief summary
Bowel management in the Intensive Care Unit is a generally overlooked issue. Both constipation and diarrhoea appear common in critical care patients. Their causes are multi-factorial and associated with adverse outcomes. In the intensive care unit at the Austin Hospital, two approaches to bowel management are typically used and are reflective of practice in other intensive care units worldwide. These two approaches are either an ‘early aperient use’ or a ‘delayed aperient use’ approach. However, the evidence to support either approach is not of high-quality. Thus, clinicians remain uncertain about which approach is best for critically ill patients.

In response, we will perform a single-centre, cluster double crossover trial. We will include all adult patients (aged 18 years or older), who are receiving mechanical ventilation and are enterally fed via a feeding tube. Over a 12-month period, that includes four 3-month treatment periods, pods within the intensive care unit will be allocated to regimen of 'early aperient use' commencing on day 1 of admission or to a 'delayed aperient use' regimen commencing on day 6 of admission. We estimate that 880 patients will be included in the trial. Data collected for this trial will be that of standard routine care data extracted from electronic data sources.

Research findings will be used to help reduce practice variation and may be used to inform the design and conduct of future ethically approved research in the area of bowel management for critically ill patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124102 0
Prof Rinaldo Bellomo
Address 124102 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg, VIC 3084
Country 124102 0
Australia
Phone 124102 0
+6139496 5992
Fax 124102 0
+61394963932
Email 124102 0
[email protected]
Contact person for public queries
Name 124103 0
Rinaldo Bellomo
Address 124103 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg, VIC 3084
Country 124103 0
Australia
Phone 124103 0
+6139496 5992
Fax 124103 0
+61394963932
Email 124103 0
[email protected]
Contact person for scientific queries
Name 124104 0
Rinaldo Bellomo
Address 124104 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg, VIC 3084
Country 124104 0
Australia
Phone 124104 0
+6139496 5992
Fax 124104 0
+61394963932
Email 124104 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
Individual participant data will only be made available for this single-centre clinical trial from a legal basis.


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.