Stress Ulcer Prophylaxis Versus Placebo-A Blinded Pilot Randomized Controlled Trial to Evaluate the Safety of Two Strategies in Critically Ill Infants With Congenital Heart Disease.

OBJECTIVES: The routine use of stress ulcer prophylaxis (SUP) in infants with congenital heart disease (CHD) in the cardiac ICU (CICU) is controversial. We aimed to conduct a pilot study to explore the feasibility of performing a subsequent larger trial to assess the safety and efficacy of withholding SUP in this population (NCT03667703). DESIGN, SETTING, PATIENTS: Single-center, prospective, double-blinded, parallel group (SUP vs. placebo), pilot randomized controlled pilot trial (RCT) in infants with CHD admitted to the CICU and anticipated to require respiratory support for greater than 24 hours. INTERVENTIONS: Patients were randomized 1:1 (stratified by age and admission type) to receive a histamine-2 receptor antagonist or placebo until respiratory support was discontinued, up to 14 days, or transfer from the CICU, if earlier. MEASUREMENTS AND MAIN RESULTS: Feasibility was defined a priori by thresholds of screening rate, consent rate, timely drug allocation, and protocol adherence. The safety outcome was the rate of clinically significant upper gastrointestinal (UGI) bleeding. We screened 1,426 patients from February 2019 to March 2022; of 132 eligible patients, we gained informed consent in 70 (53%). Two patients did not require CICU admission after obtaining consent, and the remaining 68 patients were randomized to SUP (n = 34) or placebo (n = 34). Ten patients were withdrawn early, because of a change in eligibility (n = 3) or open-label SUP use (n = 7, 10%). Study procedures were completed in 58 patients (89% protocol adherence). All feasibility criteria were met. There were no clinically significant episodes of UGI bleeding during the pilot RCT. The percentage of patients with other nonserious adverse events did not differ between groups. CONCLUSIONS: Withholding of SUP in infants with CHD admitted to the CICU was feasible. A larger multicenter RCT designed to confirm the safety of this intervention and its impact on incidence of UGI bleeding, gastrointestinal microbiome, and other clinical outcomes is warranted.

Clinical management of vital and non-vital discolored tooth preparation stump shades: A clinical case series.

OBJECTIVE: Traditional and modern-day laboratory techniques can be used to mask vital and non-vital discolored teeth. CLINICAL CONSIDERATIONS: Two clinical case reports are presented showing different treatment approaches to differing clinical scenarios of partial coverage veneer and full coverage crown restorations, respectively. CONCLUSIONS: Feldspathic ceramics should be considered when customization of stump shade correction and equalization is required with minimum facial reduction with veneer restorations. Translucent zirconia (5 mol% Y2 O3 ) can be used to mask metal posts and core restorations on non-vital teeth using an opaquer material that is infused into the intaglio surface in the green state. CLINICAL SIGNIFICANCE: Different clinical scenarios will present to the clinician in regard to discolored stump shades where understanding what laboratory material treatment options are available that will help guide definitive restoration types and ultimately tooth preparation design.