Fasting vs no fasting prior to catheterisation laboratory procedures: the SCOFF trial.

BACKGROUND AND AIMS: Current guidelines recommend 6 hours of solid food and 2 hours of clear liquid fasting for patients undergoing cardiac procedures with conscious sedation. There are no data to support this practice, and previous single centre studies support the safety of removing fasting requirements. The objective of this study was to determine the non-inferiority of a no fasting strategy to fasting prior to cardiac catheterisation procedures which require conscious sedation. METHODS: This is a multicentre, investigator-initiated, non-inferiority randomised trial conduced in Australia with a prospective open label blinded endpoint design. Patients referred for coronary angiography, percutaneous coronary intervention or cardiac implantable electronic device (CIED) related procedures were enrolled. Patients were randomised 1:1 to fasting as normal (6 hours solid food and 2 hours clear liquid) or no fasting requirements (encouraged to have regular meals but not mandated to do so). Recruitment occurred from 2022 to 2023. The primary outcome was a composite of aspiration pneumonia, hypotension, hyperglycaemia and hypoglycaemia assessed with a Bayesian approach. Secondary outcomes included patient satisfaction score, new ventilation requirement (non-invasive and invasive), new intensive care unit admission, 30-day readmission, 30-day mortality, 30-day pneumonia. RESULTS: 716 patients were randomised with 358 in each group. Those in the fasting arm had significantly longer solid food fasting (13.2 versus 3.0 hours, Bayes factor >100 indicating extreme evidence of difference) and clear liquid fasting times (7.0 versus 2.4 hours, Bayes factor >100). The primary composite outcome occurred in 19.1% of patients in the fasting arm and 12.0% of patients in the no fasting arm. The estimate of the mean posterior difference in proportions in the primary composite outcome was -5.2% (95% CI -9.6 to -0.9, ) favouring no fasting. This result confirms non-inferiority (posterior probability >99.5%) and superiority (posterior probability 99.1%) of no fasting for the primary composite outcome. The no fasting arm had improved patient satisfaction scores with a posterior mean difference of 4.02 points (95% CI 3.36 to 4.67, Bayes factor >100). Secondary outcome events were similar. CONCLUSIONS: In patients undergoing cardiac catheterisation and CIED related procedures, no fasting was non-inferior and superior to fasting for the primary composite outcome of aspiration pneumonia, hypotension, hyperglycaemia and hypoglycaemia. Patient satisfaction scores were significantly better with no fasting. This supports removing fasting requirements for patients undergoing cardiac catheterisation laboratory procedures that require conscious sedation.

Safety and care of no fasting prior to catheterization laboratory procedures: a non-inferiority randomized control trial protocol (SCOFF trial).

Aims: Cardiac catheterization procedures are typically performed with local anaesthetic and proceduralist guided sedation. Various fasting regimens are routinely implemented prior to these procedures, noting the absence of prospective evidence, aiming to reduce aspiration risk. However, there are additional risks from fasting including patient discomfort, intravascular volume depletion, stimulus for neuro-cardiogenic syncope, glycaemic outcomes, and unnecessary fasting for delayed/cancelled procedures. Methods and results: This is an investigator-initiated, multicentre, randomized trial with a prospective, open-label, blinded endpoint (PROBE) assessment based in New South Wales, Australia. Patients will be randomized 1:1 to fasting (6 h solid food and 2 h clear liquids) or to no fasting requirements. The primary outcome will be a composite of hypotension, hyperglycaemia, hypoglycaemia, and aspiration pneumonia. Secondary outcomes will include patient satisfaction, contrast-induced nephropathy, new intensive care admission, new non-invasive or invasive ventilation requirement post procedure, and 30-day mortality and readmission. Conclusions: This is a pragmatic and clinically relevant randomised trial designed to compare fasting verse no fasting prior to cardiac catheterisation procedures. Routine fasting may not reduce peri-procedural adverse events in this setting.

Retrospective evaluation of plasma cholesterol concentration in septic dogs and its association with morbidity and mortality: 51 cases (2005-2015).

OBJECTIVE: To determine whether plasma cholesterol concentrations in dogs with sepsis is associated with morbidity or in-hospital mortality. DESIGN: Retrospective cohort study from 2005-2015. SETTING: Two private referral centers. ANIMALS: Fifty-one dogs diagnosed with sepsis. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Dogs were classified as septic if they displayed ≥2 criteria of the systemic inflammatory response syndrome in conjunction with a documented underlying infectious cause. Dogs were excluded if they had been diagnosed previously with any concurrent illness reported to alter plasma cholesterol concentrations. Plasma cholesterol concentrations at the time of sepsis diagnosis were statistically analyzed for association with morbidity, as measured by the presence of organ dysfunction, the number of dysfunctional organs, duration of hospitalization, cost of hospitalization, and in-hospital mortality. Twenty-eight (55%) dogs survived to discharge, 15 (29%) were euthanized during hospitalization, and 8 (16%) died despite treatment. While median cholesterol concentrations were significantly different when comparing survivors to discharge versus nonsurvivors who died naturally despite treatment (P = 0.0245), they were not significantly different when comparing survivors to all nonsurvivors (P = 0.1821). Receiver operating characteristic curve analysis showed a cholesterol cutoff of 4.5 mmol/L (174 mg/dL) with a sensitivity of 75% and a specificity of 50% for predicting in-hospital mortality. For surviving dogs, plasma cholesterol concentrations were not associated with increased length of hospital stay. Number of dysfunctional organs and plasma cholesterol concentration were the 2 most significant individual predictors for survival, and when incorporated into a multivariate logistic regression model used for prediction, the model yielded a sensitivity of 94% and specificity of 63%. CONCLUSION: Plasma cholesterol concentration can provide prognostic information in dogs with sepsis. Further prospective studies investigating the role of cholesterol in sepsis are needed.