Table 2

Schedule of events

Time pointEnrolment screeningAllocationStudy interventionClose-out
0-72 hrs prior to intervention start0–12 hrs prior to intervention start0 hr48 hrs5 days14 days30 days90 days
Enrolment
Clostridium  difficile stool toxin test results  positive
Eligibility assessment
 Relevant medical history
 Physical examination
 General Surgery consultation
Laboratory
 Complete blood count
 Serum creatinine
 Serum albumin
 Serum lactate
 Serum/urine beta-HCG (when clinically appropriate)
Imaging
 Abdominal imaging
 Organ dysfunction and comorbidity index assessments
 Written consent provided by patient or SDM
Randomisation
 Interventions
Control group
 Nil per os
 Metronidazole 500 mg IV every 8 hours
 Vancomycin 500 mg orally every 6 hours
Intervention group
 Nil per os
 Insertion of NJ or NG feeding tube (two-step with CXR and AXR to confirm positioning)
 Insertion of faecal management system (if clinically appropriate)
 Metronidazole 500 mg IV every 8 hours
 Vancomycin 500 mg orally every 6 hours
 Polyethylene glycol intestinal lavage
Assessment
 Mortality
 Protocol compliance (see definition in text)
 Intervention intolerance assessment (see definition in text)
Adverse events assessment
 Assessment of surgeons' reported indication for surgical intervention
 Non-surgical intervention for abdominal compartment syndrome
 Assess for ICU admission
 Mechanical ventilator support
 Vasopressor support
 Aspiration pneumonitis or pneumonia
Complications related to NJ/NG tubes
 Pneumothorax
 Perforation
 Haemorrhage
Complications related to faecal management system
 Perforation
 Haemorrhage
 Other complications
  • Legend: ◆ discrete event; □ start and stop of continuous intervention.

  • AXR, abdominal X-ray; CXR, chest X-ray; HCG, human chorionic gonadotropin; ICU, intensive care unit; IV, intravenous; NG, nasogastric; NJ, nasojejunal; SDM, substitute decision maker.