None listed
Conditions
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.
Interventions
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
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.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed