A Double-blinded, Randomized, Placebo-controlled Trial of Antibiotic Prophylaxis in Elective Non-hysterectomy Laparoscopic Surgery for Benign Gynecologic Conditions: A Pilot Study.

STUDY OBJECTIVE: To determine the feasibility of a double-blinded randomized, placebo-controlled study in determining the efficacy of antibiotic prophylaxis in preventing postoperative infections (POIs) in elective nonhysterectomy laparoscopic procedures for benign gynecologic conditions. DESIGN: Double-blinded, randomized, placebo-controlled trial. SETTING: University-affiliated tertiary referral hospital in Sydney, Australia. PATIENTS: Women older than 18 years undergoing elective nonhysterectomy laparoscopic procedures for benign gynecologic conditions were eligible for the study and approached. INTERVENTIONS: Before surgery, participants were randomized to receive either 2-g cephazolin or placebo (10-mL normal saline) administered by the anesthetist. Participants and other research staff were blinded to group allocation. MEASUREMENTS AND MAIN RESULTS: The primary outcome was study feasibility measured by recruitment rates, compliance rates of drug administration, compliance rates of delivery, maintenance of double blinding, and follow-up rates. Secondary outcomes included rate of POIs, length of hospitalization, readmission to hospital, unscheduled presentations to healthcare facilities, and antibiotic-related reactions. Between February 2019 and March 2021, 170 patients were approached with 117 participants (68.8%) recruited and randomized. The study had a high compliance rate of trial drug delivery (95.7%) and a high follow-up rate (99.1%). CONCLUSION: This pilot study has demonstrated feasibility of a large-scale study with a recruitment rate of 68% of patients approached and excellent trial drug delivery and follow-up rates. As anticipated, it is underpowered for identifying clinically significant findings for POI rates. A large-scale study is appropriate and essential to determine the health-related risks of antibiotic prophylaxis with an emphasis on antimicrobial stewardship. The sample size for a large-scale study is 1678 participants based on infection rates in this pilot study.

Accuracy of documented administration times for intravenous antimicrobial drugs and impact on dosing decisions.

AIMS: Accurate documentation of medication administration time is imperative for many therapeutic decisions, including dosing of intravenous antimicrobials. The objectives were to determine (1) the discrepancy between actual and documented administration times for antimicrobial infusions and (2) whether day of the week, time of day, nurse-to-patient ratio and drug impacted accuracy of documented administration times. METHODS: Patient and dosing data were collected (June-August 2019) for 55 in-patients receiving antimicrobial infusions. "Documented" and "actual" administration times (n = 660) extracted from electronic medication management systems and smart infusion pumps, respectively, were compared. Influence of the day (weekday/weekend), time of day (day/evening/night), nurse-to-patient ratio (high 1:1/low 1:5) and drug were examined. Monte Carlo simulation was used to predict the impact on dose adjustments for vancomycin using the observed administration time discrepancies compared to the actual administration time. RESULTS: The median discrepancy between actual and documented administration times was 16 min (range, 2-293 min), with discrepancies greater than 60 minutes in 7.7% of administrations. Overall, discrepancies (median [range]) were similar on weekends (17 [2-293] min) and weekdays (16 [2-188] min), and for high (16 [2-157] min) and low nurse-to-patient ratio wards (16 [2-293] min). Discrepancies were smallest for night administrations (P < .05), and antimicrobials with shorter half-lives (P < .0001). The observed discrepancies in vancomycin administration time resulted in a different dose recommendation in 58% of cases (30% higher, 28% lower). CONCLUSIONS: Overall, there were discrepancies between actual and documented antimicrobial infusion administration times. For vancomycin, these discrepancies in administration time were predicted to result in inappropriate dose recommendations.

Outcomes of venoarterial extracorporeal membrane oxygenation for refractory cardiogenic shock: systematic review and meta-analysis.

BACKGROUND: Despite advances in management techniques and medical therapy, refractory cardiogenic shock remains a life-threatening condition with high mortality rates. The present systematic review and meta-analysis aims to explore the outcomes associated with venoarterial extracorporeal membrane oxygenation (VA-ECMO) use in the setting of refractory cardiogenic shock, stratified per survivorship. METHODS: A literature search was performed using three electronic databases from the date of their inception up to June 2018. The literature search and subsequent data extraction were performed by two independent reviewers. Digitized survival data were extracted from Kaplan-Meier curves in order to re-create the original patient data using an iterative algorithm and were subsequently aggregated for analysis. RESULTS: Fifty-two studies were included, with 44 undergoing quantitative analysis. A total of 17,515 patients were identified, with a mean age of 58.4±9.4 years and a mean duration of ECMO support of 5.1±2.6 days; 68.7% of the patients were male. Aggregated survival rates at 1, 2, 3 and 5 years were 36.7%, 34.8%, 33.8% and 29.9%, respectively. CONCLUSIONS: The present systematic review illustrates the expected survival results for VA-ECMO in the intermediate- to long-term. Extended follow-up and standardized reporting measures are urgently needed in order to carry out more definitive subgroup analyses.