Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia (COVID STEROID) trial—Protocol and statistical analysis plan

Introduction

Severe acute respiratory syndrome coronavirus-2 has caused a pandemic of coronavirus disease (COVID-19) with many patients developing hypoxic respiratory failure. Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations. However, corticosteroids have undesirable effects, including longer time to viral clearance. Clinical equipoise on the use of corticosteroids for COVID-19 exists.

Methods

The COVID STEROID trial is an international, randomised, stratified, blinded clinical trial. We will allocate 1000 adult patients with COVID-19 receiving ≥10 L/min of oxygen or on mechanical ventilation to intravenous hydrocortisone 200 mg daily vs placebo (0.9% saline) for 7 days. The primary outcome is days alive without life support (ie mechanical ventilation, circulatory support, and renal replacement therapy) at day 28. Secondary outcomes are serious adverse reactions at day 14; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality at day 28, day 90, and 1 year; and health-related quality of life at 1 year. We will conduct the statistical analyses according to this protocol, including interim analyses for every 250 patients followed for 28 days. The primary outcome will be compared using the Kryger Jensen and Lange test in the intention to treat population and reported as differences in means and medians with 95% confidence intervals.

Discussion

The COVID STEROID trial will provide important evidence to guide the use of corticosteroids in COVID-19 and severe hypoxia.

     

Does prophylactic sotalol and magnesium decrease the incidence of atrial fibrillation following coronary artery bypass surgery: a propensity-matched analysis

Background  

Atrial fibrillation can occur in up to 40% of patients undergoing coronary surgery.     

Removal of surface bacteria by irrigation

We examined the efficacy of various irrigation solutions delivered through a power irrigator to remove bacteria from three different surfaces. Titanium, stainless-steel, and cortical bone surfaces were coated with three different bacterial species: Staphylococcus aureus, Pseudomonas aeruginosa, and Staphylococcus epidermidis. They were then irrigated with 1 L of fluid delivered by jet lavage. The fluids tested were normal saline and solutions of bacitracin, neomycin, and soap. One set of specimens was not irrigated, as a control. After irrigation, the specimens were sonicated to remove residual bacteria, and the sonicate was quantitatively cultured to allow evaluation of the amount of residual bacteria on the surface. The results showed that removal of bacteria reflects an interaction between bacterial species, surface characteristics, and irrigation solution. Fewer bacteria were present in all the irrigation groups than in the control. Soap solution was as good as or better than any other solution at removing all three types of bacteria from all three surfaces, although not all of the pairwise comparisons were statistically significant. There was a significant advantage to soap solution over antibiotic irrigant or saline alone in removing Staphylococcus epidermidis from metallic surfaces. The use of a soap solution for irrigation seems to improve the removal of some bacteria from some surfaces in this experimental model and may represent a better type of irrigation additive.     

Intimal hyperplasia and coronary flow reserve after heart transplantation: association with big endothelin-1

BACKGROUND: Endothelin, a peptide with strong vasoconstrictive and mitogenic properties, has been found to increase after cardiac transplantation. We therefore assessed the association between its precursor peptide, big endothelin-1, and intimal hyperplasia and coronary flow reserve after heart transplantation. METHODS: Thirty-five patients without hemodynamically significant coronary artery disease after heart transplantation were investigated: Average peak flow velocity in the left anterior descending artery (LAD) was assessed by intracoronary Doppler at baseline as well as after injection of adenosine; coronary flow reserve was calculated as a ratio of both and was corrected for patient age and baseline average peak flow velocity. Lumen, intima + media and total vessel area were measured by intracoronary ultrasound. The plasma concentration of big endothelin-1 in venous blood was determined by radioimmunoassay. RESULTS: Patients with elevated big endothelin-1 levels (>2 fmol/ml) tended to have a decreased corrected coronary flow reserve (2.60 +/- 0.9 vs 3.21 +/- 1.0, p = 0.078). They also had a significantly larger intima + media area (5.82 +/- 2.9 vs 2.37 +/- 2.9 mm(2), p = 0.004) and total vessel area (18.36 +/- 5.8 vs 12.81 +/- 4.8 mm(2), p = 0.012) than those with normal plasma concentrations. CONCLUSIONS: Our study suggests an association between elevated big endothelin-1 plasma levels and the development of intimal hyperplasia and reduction of coronary flow reserve after cardiac transplantation.     

Systemic lupus erythematosus with rectal stenosis simulating tumour or diverticulosis. Case report

A case of systemic lupus erythematosus (SLE) with focal involvement of the rectum is reported. The lesion roentgenologically resembled a malignant tumour and was resected. Histologic examination disclosed only typical SLE changes in a very restricted area, with the remaining gastrointestinal tract unaffected. This appears to be the first report of focal colitis as a complication of SLE. The case points the importance of suspecting symptoms from any organ system in patients with connective tissue disorders to be manifestations of that underlying pathology.