Skip to main content

Table 1 Participant timeline

From: Effects of the peripherally acting μ-opioid receptor antagonist methylnaltrexone on acute pancreatitis severity: study protocol for a multicentre double-blind randomised placebo-controlled interventional trial, the PAMORA-AP trial

  1. 1Baseline variables: sex, age, height, weight, time of symptom onset, time of hospitalisation, weekly alcohol consumption, smoking status, Charlson comorbidity index-score [37]
  2. 2Primary endpoint: Pancreatitis activity scoring system (PASS) score after 48 h
  3. 3Secondary endpoints: daily PASS scores; disease severity according to the Atlanta classification; daily questionnaires: The modified Brief Pain Inventory short form [31], Bristol Stool Form Scale [32], and Gastrointestinal Symptom Rating Scale [33]; clinical outcome parameters: quantification of need for analgesics, nutritional support, intravenous fluid resuscitation and antibiotics; health resource utilisation: invasive treatments, intensive care, readmission rates and duration of hospital admissions; and mortality
  4. 4Exploratory outcomes: daily levels of circulating pro- and anti-inflammatory markers; daily levels of circulating blood markers of intestinal permeability; polyethylene glycol 400/4000 test [35]; gut transit assessed using a CT-based radiopaque marker method [36] and pancreatic complications: assessed and quantified by contrast-enhanced CT according to the revised Atlanta criteria [25]