Time point | Enrolment screening | Allocation | Study intervention | Close-out | ||||
0-72 hrs prior to intervention start | 0–12 hrs prior to intervention start | 0 hr | 48 hrs | 5 days | 14 days | 30 days | 90 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.