VLCKD: a real time safety study in obesity

Background Very Low-Calorie Ketogenic Diet (VLCKD) is currently a promising approach for the treatment of obesity. However, little is known about the side effects since most of the studies reporting them were carried out in normal weight subjects following Ketogenic Diet for other purposes than obesity. Thus, the aims of the study were: (1) to investigate the safety of VLCKD in subjects with obesity; (2) if VLCKD-related side effects could have an impact on its efficacy. Methods In this prospective study we consecutively enrolled 106 subjects with obesity (12 males and 94 females, BMI 34.98 ± 5.43 kg/m2) that underwent to VLCKD. In all subjects we recorded side effects at the end of ketogenic phase and assessed anthropometric parameters at the baseline and at the end of ketogenic phase. In a subgroup of 25 subjects, we also assessed biochemical parameters. Results No serious side effects occurred in our population and those that did occur were clinically mild and did not lead to discontinuation of the dietary protocol as they could be easily managed by healthcare professionals or often resolved spontaneously. Nine (8.5%) subjects stopped VLCKD before the end of the protocol for the following reasons: 2 (1.9%) due to palatability and 7 (6.1%) due to excessive costs. Finally, there were no differences in terms of weight loss percentage (13.5 ± 10.9% vs 18.2 ± 8.9%; p = 0.318) in subjects that developed side effects and subjects that did not developed side effects. Conclusion Our study demonstrated that VLCKD is a promising, safe and effective therapeutic tool for people with obesity. Despite common misgivings, side effects are mild, transient and can be prevented and managed by adhering to the appropriate indications and contraindications for VLCKD, following well-organized and standardized protocols and performing adequate clinical and laboratory monitoring.

136. Impact of an OPAT Pharmacist on Guideline Adherence and Clinical Outcomes

Background Outpatient parenteral antibiotic therapy (OPAT) provides select patients a cost-effective alternative to completing intravenous (IV) antibiotic therapy outside the hospital. The Infectious Diseases Society of America (IDSA) OPAT practice guidelines and handbook recommend weekly laboratory monitoring and timely follow-up for OPAT patients. An analysis at VA Palo Alto Healthcare System (VAPAHCS) conducted prior to pharmacist involvement demonstrated that IDSA recommendations were not routinely followed, leading to a clinical cure rate of 62.7%. This led to the implementation of an OPAT pharmacist in 2019. This analysis aims to determine the impact of a pharmacist-managed OPAT program at VAPAHCS. Methods This comparative, retrospective analysis included patients who received OPAT at VAPAHCS between October 1, 2019 and September 30, 2020 and those who received OPAT in a prior analysis. Primary outcomes included rates of adherence to IDSA recommendations on follow-up visits and weekly lab monitoring during OPAT. Secondary outcomes included rates of clinical cure, 90-day readmission, and adverse events or complications. Data was analyzed using Fisher’s exact test and independent t-test. Results This analysis included 74 patients and 76 total OPAT episodes. Bacteremia was the most common diagnosis (n=35, 38.0%), and the most common organism was methicillin-susceptible Staphylococcus aureus (MSSA) (n=23, 29.9%). With respect to guideline adherence pre- and post- pharmacist-managed OPAT, 31.3% versus 93.4% of patients had follow-up within 7 to 14 days of discharge (p< 0.001). Rates of weekly lab monitoring of CBC, BMP, and LFTs pre-pharmacist were 63.2%, 63.3%, and 49.5%, respectively, compared to post-pharmacist rates of 93.0%, 92.1%, and 83.6%, respectively. Clinical cure rates were 62.7% pre-pharmacist and 89.6% post-pharmacist (p< 0.001). More adverse drug reactions were identified in the post-pharmacist period, of which 30% required pharmacist intervention. Figure 1. Weekly Laboratory Monitoring of Antimicrobials (%) Figure 2. Adherence to IDSA Guideline Follow-up Recommendation Figure 3. Rates of Clinical Cure Conclusion Pharmacist involvement in OPAT significantly increased IDSA guideline adherence to lab monitoring and follow-up visits, and clinical cure rates. Identification of adverse drug reactions prompting pharmacist intervention further highlights the importance of follow-up in OPAT patients. Disclosures All Authors: No reported disclosures

858. Impact of Using an Order Set on PrEP Prescribing and Laboratory Monitoring in Primary Care

Background CDC 2017 pre-exposure prophylaxis (PrEP) guideline recommends laboratory monitoring at baseline and follow-up and specifies that a PrEP prescription should be written for once daily dosing with a supply of 90 days or less to ensure patients repeat HIV testing every 3 months. This presents an opportunity to utilize order sets in the electronic health record to improve PrEP prescribing habits and prescriber adherence to laboratory monitoring recommendations. This study assessed the impact of using an order set on the accuracy of PrEP prescriptions and the appropriateness of laboratory monitoring in the primary care setting. Methods This was a retrospective, single-center, observational cohort study conducted at primary care clinics at a large academic health system. A total of 228 PrEP prescriptions from adults at least 18 years of age and that were written between April 1, 2018 through May 31, 2020 were assigned to the two comparator groups: 176 prescriptions ordered without an order set and 52 prescriptions ordered with an order set. The primary outcome was a composite of correct prescription details, defined as once daily dosing of PrEP for a 90-day supply or less. Secondary outcomes included the frequency of having an HIV antigen/antibody (Ag/Ab) test ordered within 3 months of the PrEP prescription, and the composite of appropriate baseline labs ordered for those newly starting PrEP. Results Baseline characteristics are shown in Table 1. The primary outcome of correct prescription details occurred in 100% of PrEP prescriptions ordered with an order set compared to 65.9% of those ordered without an order set (P< 0.001). At least 1 HIV Ag/Ab test was appropriately repeated within 3 months for 65.4% of PrEP prescriptions ordered with an order set and 42.6% ordered without an order set (P=0.004). In those initiating PrEP, a composite of correct baseline labs ordered occurred with 14 (73.7%) new start prescriptions ordered with an order set versus 47 (42.7%) ordered without an order set (P=0.023). Conclusion When ordering PrEP, order set use significantly improved the accuracy of PrEP prescriptions and appropriateness of laboratory monitoring at baseline and at follow-up compared to no order set use at primary care clinics of a large academic health system. Disclosures All Authors: No reported disclosures

About the absence of the need to prescribe antibacterial therapy to newborns from mothers with clinical chorioamnionitis

Background. The diagnosis of a woman in labor chorioamnionitis (CA) implies a high risk of infectious complications for the mother and fetus, which determines the need for additional examination of infants and the decision on the appointment of antibacterial therapy. The purpouse of this study was determine the need to administration antibiotic therapy to full-term newborns from mothers diagnosed with chorioamnionitis. Materials and methods. 113 full-term newborns were examined, of which the main group consisted of children whose mothers were diagnosed with chorioamnionitis (n = 77), the comparison group children born to healthy mothers (n = 36). All children performed clinical and laboratory monitoring, including a clinical analysis of capillary blood in the first 24 hours of life; determination of the level of C-reactive protein (CRP) in venous blood on the 3rd day of life. Bacteriological examination of newborns included sampling of material from the ear fold, buccal mucosa, umbilical cord blood, as well as the contents of the tracheobronchial tree (TBD) during respiratory therapy with mechanical ventilation. Special research methods included studies of the proinflammatory cytokines (IL-1, IL-6) in umbilical cord blood. Histological CA was diagnosed in the presence of morphological and functional signs of inflammation in the placenta. Results. Newborns of the main group more often developed respiratory disorders requiring respiratory and oxygen therapy (p = 0,045). The production of IL-1, IL-6 in umbilical cord blood in the examined newborns of the main group was higher than in the comparison group [Odds Ratio (OR) 8.4; 95% Confidence Interval (CI): 1.067.9; OR 7.4; 95% CI: 2.521.7 respectively]. The study of blood samples revealed leukocytosis (34109) 6.5% vs 0%, p 0.05) and a shift in the leukocyte count to young forms of neutrophils (45.4% vs 16.7%, p 0.05) in the peripheral blood of infants of the main group. Infants exposed to maternal clinical chorioamnionitis had increased level of CRP 10.3 times more frequent (95% CI: 2.837.1) than in newborns in the comparison group. With dynamic clinical and laboratory monitoring, 72 children of the main group (93.5%) had no data for the course of the infection, as a result of which they did not receive antibiotic therapy. Conclusion: Administration antibiotic therapy to clinically healthy full-term newborns from mothers diagnosed with chorioamnionitis is unjustified. Infants of this group require clinical laboratory, dynamic observation with laboratory control, including a clinical blood test and determination of the CRP level, which is a preferred alternative to the appointment of antibiotic therapy.

Laboratory Monitoring of Mother, Fetus, and Newborn in Hemolytic Disease of Fetus and Newborn

<b><i>Background:</i></b> Laboratory monitoring of mother, fetus, and newborn in hemolytic disease of fetus and newborn (HDFN) aims to guide clinicians and the immunized women to focus on the most serious problems of alloimmunization and thus minimize the consequences of HDFN in general and of anti-D in particular. Here, we present the current approach of laboratory screening and testing for prevention and monitoring of HDFN at the Copenhagen University Hospital in Denmark. <b><i>Summary:</i></b> All pregnant women are typed and screened in the 1st trimester. This serves to identify the RhD-negative pregnant women who at gestational age (GA) of 25 weeks are offered a second screen test and a non-invasive fetal RhD prediction. At GA 29 weeks, and again after delivery, non-immunized RhD-negative women carrying an RhD-positive fetus are offered Rh immunoglobulin. If the 1st trimester screen reveals an alloantibody, antenatal investigation is initiated. This also includes RhD-positive women with alloantibodies. Specificity and titer are determined, the fetal phenotype is predicted by non-invasive genotyping based on cell-free DNA (RhD, K, Rhc, RhC, RhE, ABO), and serial monitoring of titer commences. Based on titers and specificity, monitoring with serial peak systolic velocity measurements in the fetal middle cerebral artery to detect anemia will take place. Intrauterine transfusion is given when fetal anemia is suspected. Monitoring of the newborn by titer and survival of fetal red blood cells by flow cytometry will help predict the length of the recovery of the newborn.