[Posted 4/Mar/2025]

AUDIENCE: Nursing

KEY FINDINGS:

BACKGROUND: Diaper rash is a frequent diagnosis among neonates in the Neonatal Intensive Care Unit (NICU). It is characterized by an acute inflammatory eruption of the skin in the diaper area.

DETAILS: This study aimed to investigate the effect of colloid oatmeal and colloid cream on diaper rash among preterm neonates in the NICU. This study took place in the NICU of El-Raml Children's Hospital at Wengat in Alexandria, Egypt. Using a randomized control trial pre-posttest design with three parallel groups. Ninety preterm neonates with diaper rash were randomly assigned to three equal groups. Diaper Dermatitis Scale attached with demographic and clinical data was used. The outcome was assessed for four consecutive days for each group. Preterm neonates who received colloid oatmeal had significantly declined in the total mean score of severity of diaper rash in 3rd and 4th days with mean 0.833 ± 1.234 and 0.000 ± 0.000 compared to 2.333 ± 0.844 and 1.500 ± 1.224 in colloid group and 2.566 ± 0.817 and 1.966 ± 1.325 in the control group (p₁ = 0.027 in the 4th day, and p₂ and p₃ < 0.001 for each day).

Copyright © Neonatal Nurses Association. Published by Elsevier Ltd. All rights reserved.

Source: Saleh. S. E., Ismail, E.M., Fathy, H. M. A. E., et al. (2024). The Effect of Colloid Oatmeal Compared to Colloid Cream on Diaper Rash Among Preterm Neonates in the Neonatal Intensive Care Unit. J. Neonatal Nurs.. 2025; 31(1): 135-145. Published: February, 2025. DOI: 10.1016/j.jnn.2024.07.017.

A Phase 3 Randomized Clinical Trial

[Posted 11/Mar/2025]

AUDIENCE: Psychiatry, Family Medicine, Nursing

KEY FINDINGS: Results of this randomized clinical trial show that brexpiprazole + sertraline combination treatment statistically significantly improved PTSD symptoms vs sertraline + placebo, indicating its potential as a new efficacious treatment for PTSD. Brexpiprazole + sertraline was tolerated by most participants, with a safety profile consistent with that of brexpiprazole in approved indications.

BACKGROUND: New pharmacotherapy options are needed for posttraumatic stress disorder (PTSD). Purpose of this study is to investigate the efficacy, safety, and tolerability of brexpiprazole and sertraline combination treatment (brexpiprazole + sertraline) compared with sertraline + placebo for PTSD.

DETAILS: This was a parallel-design, double-blind, randomized clinical trial conducted from October 2019 to August 2023. The study had a 1-week, placebo run-in period followed by an 11-week, double-blind, randomized, active-controlled, parallel-arm period (with 21-day follow-up) and took place at 86 clinical trial sites in the US. Adult outpatients with PTSD were enrolled (volunteer sample). The primary end point was change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score (which measures the severity of 20 PTSD symptoms) from randomization (week 1) to week 10 for brexpiprazole + sertraline vs sertraline + placebo. Safety assessments included adverse events. A total of 1327 individuals were assessed for eligibility. After 878 screen failures, 416 participants (mean [SD] age, 37.4 [11.9] years; 310 female [74.5%]) were randomized. Completion rates were 137 of 214 participants (64.0%) for brexpiprazole + sertraline and 113 of 202 participants (55.9%) for sertraline + placebo. At week 10, brexpiprazole + sertraline demonstrated statistically significant greater improvement in CAPS-5 total score (mean [SD] at randomization, 38.4 [7.2]; LS mean [SE] change, -19.2 [1.2]; n = 148) than sertraline + placebo (randomization, 38.7 [7.8]; change, -13.6 [1.2]; n = 134), with LS mean difference, -5.59 (95% CI, -8.79 to -2.38; P .001). All key secondary and other efficacy end points were also met. Treatment-emergent adverse events with incidence of 5% or greater for brexpiprazole + sertraline (and corresponding incidences for sertraline + placebo) were nausea (25 of 205 [12.2%] and 23 of 196 [11.7%]), fatigue (14 of 205 [6.8%] and 8 of 196 [4.1%]), weight increase (12 of 205 [5.9%] and 3 of 196 [1.5%]), and somnolence (11 of 205 [5.4%] and 5 of 196 [2.6%]). Discontinuation rates due to adverse events were 8 of 205 participants (3.9%) for brexpiprazole + sertraline and 20 of 196 participants (10.2%) for sertraline + placebo.

Copyright © American Medical Association. All Rights Reserved.

Source: Davis, L. L., Behl, S., Lee, D., et al. (2024). Brexpiprazole and Sertraline Combination Treatment in Posttraumatic Stress Disorder: A Phase 3 Randomized Clinical Trial. JAMA Psychiatry. 2025; 82(3): 218-227. Published: March, 2025. DOI: 10.1001/jamapsychiatry.2024.3996.

[Posted 3/Mar/2025]

AUDIENCE: Endocrinology, Family Medicine

KEY FINDINGS: The FDA has resolved the shortage of semaglutide injection products, a glucagon-like peptide 1 (GLP-1) medication, meeting US demand, ending a nearly 3-year shortage. Patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.

BACKGROUND: FDA has determined the shortage of semaglutide injection products, a glucagon-like peptide 1 (GLP-1) medication, is resolved. Semaglutide injection products have been in shortage since 2022 due to increased demand.

DETAILS: FDA confirmed with the drug's manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand. Patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.

To avoid unnecessary disruption to patient treatment, the agency does not intend to take action against compounders for violations of the FD&C Act arising from conditions that depend on semaglutide injection products’ inclusion on FDA’s drug shortage list:

• For a state-licensed pharmacy or physician compounding under section 503A of the FD&C Act: compounding, distributing or dispensing semaglutide injection products that are essentially a copy of an FDA-approved product within 60 calendar days from today's announcement, until April 22, 2025.
• For outsourcing facilities under section 503B of the FD&C Act: compounding, distributing or dispensing semaglutide injection products that are essentially a copy of an FDA-approved drug product within 90 calendar days from today’s announcement, until May 22, 2025. FDA may still take action regarding violations of any other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe.

Current shortage status of other GLP-1 products (as of February 21, 2025):

FDA continues to actively monitor drug availability and is currently working to determine whether the demand or projected demand for each drug in shortage exceeds the available supply.

• Dulaglutide injection: In shortage. Manufacturer has reported all presentations are available.
• Liraglutide injection: In shortage. Manufacturer has reported two presentations are available, and three have limited availability.

Source: FDA cLarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize. FDA. Published: February, 21, 2025.

A Case Report

[Posted 11/Feb/2025]

AUDIENCE: Nursing

KEY FINDINGS: This case report describes the use of prone positioning in a pregnant patient. The report offers critical care nurses insights into the clinical management of patients who are pregnant or have intra-abdominal hypertension.

BACKGROUND: Prone ventilation is a standard treatment for acute respiratory distress syndrome, and its clinical benefits are well established. However, implementing prone positioning safely and effectively is challenging in patients who are pregnant, have intra-abdominal hypertension, or are in other high-risk groups.

DETAILS: A patient in the third trimester of pregnancy (28 weeks and 6 days of gestation) developed a body temperature of 39 °C and severe respiratory distress. She was transferred to the intensive care unit, received noninvasive ventilation, and ultimately underwent endotracheal intubation. Because her oxygenation index remained below 100, she received a diagnosis of severe acute respiratory distress syndrome. The patient was safely placed in the prone position with a swim ring while receiving venovenous extracorporeal membrane oxygenation. During this period, her intra-abdominal pressure did not increase significantly. Outcomes: The fetus was delivered by cesarean birth, and the patient was transferred to the general ward after extubation.

Copyright © American Association of Critical-Care Nurses. All rights reserved.

Source: Xu, J., Fu, F., Ding, Q., et al. (2024). Prone Positioning in a Pregnant Woman With Severe Acute Respiratory Distress Syndrome: A Case Report. Crit Care Nurse. 2024; Published: February, 2025. DOI: 10.4037/ccn2025831.

Primary Results of the PEERLESS Randomized Controlled Trial

[Posted 4/Feb/2025]

AUDIENCE: Cardiology, Emergency Medicine

KEY FINDINGS: PEERLESS met its primary end point in favor of LBMT compared with CDT in treatment of intermediate-risk pulmonary embolism. LBMT had lower rates of clinical deterioration and/or bailout and postprocedural intensive care unit use compared with CDT, with no difference in mortality or bleeding.

BACKGROUND: There are a lack of randomized controlled trial data comparing outcomes of different catheter-based interventions for intermediate-risk pulmonary embolism.

DETAILS: PEERLESS is a prospective, multicenter, randomized controlled trial that enrolled 550 patients with intermediate-risk pulmonary embolism with right ventricular dilatation and additional clinical risk factors randomized 1:1 to treatment with large-bore mechanical thrombectomy (LBMT) or catheter-directed thrombolysis (CDT). The primary end point was a hierarchal win ratio composite of the following (assessed at the sooner of hospital discharge or 7 days after the procedure): (1) all-cause mortality, (2) intracranial hemorrhage, (3) major bleeding, (4) clinical deterioration and/or escalation to bailout, and (5) postprocedural intensive care unit admission and length of stay. Assessments at the 24-hour visit included respiratory rate, modified Medical Research Council dyspnea score, New York Heart Association classification, right ventricle/left ventricle ratio reduction, and right ventricular function. End points through 30 days included total hospital stay, all-cause readmission, and all-cause mortality. The primary end point occurred significantly less frequently with LBMT compared with CDT (win ratio, 5.01 [95% CI, 3.68-6.97]; P<0.001). There were significantly fewer episodes of clinical deterioration and/or bailout (1.8% versus 5.4%; P=0.04) with LBMT compared with CDT and less postprocedural intensive care unit use (P<0.001), including admissions (41.6% versus 98.6%) and stays >24 hours (19.3% versus 64.5%). There were no significant differences in mortality, intracranial hemorrhage, or major bleeding between strategies or in a secondary win ratio end point including the first 4 components (win ratio, 1.34 [95% CI, 0.78-2.35]; P=0.30). At the 24-hour visit, respiratory rate was lower for patients treated with LBMT (18.3±3.3 versus 20.1±5.1; P<0.001), and fewer had moderate to severe modified Medical Research Council dyspnea scores (13.5% versus 26.4%; P<0.001), New York Heart Association classifications (16.3% versus 27.4%; P=0.002), and right ventricular dysfunction (42.1% versus 57.9%; P=0.004). Right ventricle/left ventricle ratio reduction was similar (0.32±0.24 versus 0.30±0.26; P=0.55). Patients treated with LBMT had shorter total hospital stays (4.5±2.8 overnights versus 5.3±3.9 overnights; P=0.002) and fewer all-cause readmissions (3.2% versus 7.9%; P=0.03), whereas 30-day mortality was similar (0.4% versus 0.8%; P=0.62).

Copyright © American Heart Association, Inc. All rights reserved.

Source: Jaber, W. A., Gonsalves, C. F., Stortecky, S., et al. (2024). Large-Bore Mechanical Thrombectomy Versus Catheter-Directed Thrombolysis in the Management of Intermediate-Risk Pulmonary Embolism: Primary Results of the PEERLESS Randomized Controlled Trial. Circulation. 2025; 151(5). Published: February 4, 2025. DOI: 10.1161/CIRCULATIONAHA.124.07236.

[Posted 31/Dec/2024]

AUDIENCE: Nursing

KEY FINDINGS: Nursing staff interventions regarding shock team activation significantly improved the time of diagnosis and acceptance of patients with cardiogenic shock in a cardiovascular hospital, enhancing the overall quality of care provided to these patients.

BACKGROUND: Patients with cardiogenic shock have a 25% to 50% mortality rate despite the introduction of mechanical circulatory devices and coordinated medical treatment. The use of shock teams has improved outcomes for these patients.

DETAILS: A cardiovascular hospital with a multidisciplinary shock team had inconsistency and delays in recognition and diagnosis of patients with cardiogenic shock. A nurse-led, preintervention-postintervention quality improvement project was performed in April and May 2021 and in April and May 2022 within a cardiovascular hospital in north Texas. The 2 nursing staff interventions regarding shock team activation were education and shock alert implementation. Time from first signs to diagnosis (for inpatients) and time from initial transfer request to acceptance (for transferring patients) were measured. Descriptive and statistical analyses were conducted using R, version 4.0.0 (R Foundation for Statistical Computing). The mean (SD) time to diagnosis of cardiogenic shock decreased significantly from 17.98 (28.39) hours in the preintervention group (n = 25) to 8.15 (12.26) hours in the postintervention group (n = 45; P = .045). For patients with cardiogenic shock transferring from referring hospitals, the median (IQR) time to acceptance was 1.55 (0.08-3.18) hours in the preintervention group and 0.35 (0.00-0.72) hours in the postintervention group (P < .001).

Copyright © American Association of Critical-Care Nurses. All rights reserved.

Source: Krais, S., Sheasby, J., Banwait, J., et al. (2024). Improving Cardiogenic Shock Team Activation Through Nurse Education and Alert Implementation. Crit Care Nurse. 2024; 44(6): 24–30. Published: October, 2024. DOI: 10.4037/ccn2024259.