[Evaluation of the efficacy and safety of intravenous infusion of ferric derisomaltose in the treatment of iron deficiency anemia: a single-center retrospective analysis].

Objective: To investigate the clinical efficacy and safety of ferric derisomaltose injection versus iron sucrose injection in the treatment of iron deficiency anemia (IDA) . Methods: A total of 120 patients with iron deficiency anemia admitted from June 2021 to March 2023 were given intravenous iron supplementation with ferric derisomaltose to assess the efficacy and safety of hemoglobin (HGB) elevation before and after treatment. Simultaneously, the clinical effects of iron supplementation with iron sucrose were compared to those of inpatient patients during the same period. Results: Baseline values were comparable in both groups. Within 12 weeks of treatment, the elevated HGB level in the ferric derisomaltose group was higher than that of the iron sucrose group, with a statistical difference at all time points, and the proportion of HGB increased over 20 g/L in the patients treated for 4 weeks was higher (98.7%, 75.9% ). During the treatment with ferric derisomaltose and iron sucrose, the proportion of mild adverse reactions in the ferric derisomaltose group was slightly lower than that of the iron sucrose group, and neither group experienced any serious adverse reactions. The patients responded well to the infusion treatment, with no reports of pain or pigmentation at the injection site. Conclusion: The treatment of IDA patients with ferric derisomaltose has a satisfactory curative effect, with the advantages of rapidity, accuracy, and safety. Therefore, it is worthy of widespread clinical use.

Physical compatibility of Xuebijing injection with 53 intravenous drugs during simulated Y-site administration.

OBJECTIVE: Xuebijing injection (XBJ) is a commonly used herbal medicine injection in China. However, the physical compatibility of XBJ with other intravenous drugs remains unclear. The purpose of this research is to evaluate physical compatibility of Xuebijing injection (XBJ) with 53 intravenous drugs (including 31 Chinese medicine injections and 22 chemicals) during simulated Y-site administration. METHODS: Y-site administration was simulated in vitro by admixing 0.33 ml/ml XBJ with an equal volume of other diluted 53 intravenous drugs, respectively. Physical compatibility including visual inspection, Tyndall beam, particle limits, turbidity, pH, chromacity value, spectroscopic absorption of 550 nm and 420 nm (A550 nm and A420 nm) were observed and assessed at 0, 1, 2, and 4 h. Physical compatibility was defined as all solutions with no color changes, no gas evolution, particulate formation and no Tyndall beam within 4 hours, turbidity changes <0.5 nephelometric turbidity unit (NTU) compared to 0 h, particle limits allowed by the Chinese Pharmacopoeia (Ch.P) 2020 edition, pH changes <10% compared to 0, chromacity value changes <200 compared to 0 h, or photometrical changes of A420 nm <0.0400 or A550 nm <0.0100 compared to 0 h. RESULTS: XBJ was physically incompatible with 27 of the 53 intravenous drugs tested, 26 were compatible with XBJ for 4 h. CONCLUSIONS: XBJ should not be simultaneously co-administered with 27 of the 53 intravenous drugs during simulated Y-site. If coadministration was inevitable, flushing tube with NS or D5W before and after infusion of XBJ was needed. Assessment included visual inspection, Tyndall beam, turbidity measurement, particle counts, pH measurement, chromacity value measurement and absorption of A550 nm were proved to be valid and robust for the quality control of infusion and compatibility of Chinese herbal injection.

Physical compatibility of sulbactam/durlobactam with select intravenous drugs during simulated Y-site administration.

PURPOSE: Sulbactam/durlobactam is a combination antibiotic designed to target Acinetobacter baumannii, including carbapenem-resistant and multidrug-resistant strains. The objective of this study was to determine the physical compatibility of sulbactam/durlobactam solution during simulated Y-site administration with 95 intravenous (IV) drugs. METHODS: Vials of sulbactam/durlobactam solution were diluted in 0.9% sodium chloride injection to a volume of 100 mL (the final concentration of both drugs was 15 mg/mL). All other IV drugs were reconstituted according to the manufacturer's recommendations and diluted with 0.9% sodium chloride injection to the upper range of concentrations used clinically or tested undiluted as intended for administration. Y-site conditions were simulated by mixing 5 mL of sulbactam/durlobactam with 5 mL of the tested drug solutions in a 1:1 ratio. Solutions were inspected for physical characteristics (clarity, color, and Tyndall effect), turbidity, and pH changes before admixture, immediately post admixture, and over 4 hours. Incompatibility was defined as any observed precipitation, significant color change, positive Tyndall test, or turbidity change of ≥0.5 nephelometric turbidity unit during the observation period. RESULTS: Sulbactam/durlobactam was physically compatible with 38 out of 42 antimicrobials tested (90.5%) and compatible overall with 86 of 95 drugs tested (90.5%). Incompatibility was observed with albumin, amiodarone hydrochloride, ceftaroline fosamil, ciprofloxacin, daptomycin, levofloxacin, phenytoin sodium, vecuronium, and propofol. CONCLUSION: The Y-site compatibility of sulbactam/durlobactam with 95 IV drugs was described. These compatibility data will assist pharmacists and nurses to safely coordinate administration of IV medications with sulbactam/durlobactam.

Pharmacokinetics and Therapeutic Target Attainment of Meropenem in Pediatric Post-Liver Transplant Patients: Extended vs Intermittent Infusion.

PURPOSE: The aim of this study is to characterize the concentration-time profile, pharmacokinetics parameters, and therapeutic target attainment of meropenem in pediatric post-liver transplant patients according to the duration of infusion. METHODS: This is a prospective cohort of pediatric transplant recipients with preserved renal function receiving meropenem 40 mg/kg every 8 hours. The patients were stratified into 2 groups based on infusion duration: G1 (15 minutes of intermittent infusion) and G1 (3 hours of extended infusion). Two blood samples per child were collected during the same interval within 48 hours of starting the antimicrobial. Meropenem concentrations were determined by high-performance liquid chromatography with tandem mass spectrometry. Pharmacokinetic parameters were assessed using a noncompartmental analysis. The therapeutic target was defined as 100% of the time above the minimum inhibitory concentration. FINDINGS: Fourteen patients with 28 measured meropenem concentrations were included. Lower values of volume of distribution and meropenem clearance compared with other critically ill pediatric populations were found. All patients achieved the therapeutic target against gram-negative pathogens with a minimum inhibitory concentration of ≤8 mg/L. Patients receiving a 15-minute infusion had higher values of peak and trough concentrations, resulting in unnecessary increased total drug exposure when compared to patients receiving a 3-hour infusion (P < .05). CONCLUSIONS: Meropenem at 120 mg/kg/d attained the therapeutic target against sensitive microorganisms in pediatric liver transplant recipients. The extended infusion should be preferred for patient safety. Because of the pharmacokinetic changes resulting from liver transplantation, individualized meropenem dosing regimens may be necessary.

Adjunctive intravenous then oral vitamin C for moderate and severe community-acquired pneumonia in hospitalized adults: feasibility of randomized controlled trial.

Patients hospitalised with community acquired pneumonia (CAP) have low peripheral blood vitamin C concentrations and limited antioxidant capacity. The feasibility of a trial of vitamin C supplementation to improve patient outcomes was assessed. Participants with moderate and severe CAP (CURB-65 ≥ 2) on intravenous antimicrobial treatment were randomised to either intravenous vitamin C (2.5 g 8 hourly) or placebo before switching to oral intervention (1 g tds) for 7 days when they were prescribed oral antimicrobial therapy. Of 344 patients screened 75 (22%) were randomised and analysed. The median age was 76 years, and 43 (57%) were male. In each group, one serious adverse event that was potentially intervention related occurred, and one subject discontinued treatment. Vitamin C concentrations were 226 µmol/L in the vitamin C group and 19 µmol/L in the placebo group (p < 0.001) after 3 intravneous doses. There were no signficant differences between the vitamin C and placebo groups for death within 28 days (0 vs. 2; p = 0.49), median length of stay (69 vs. 121 h; p = 0.07), time to clinical stability (22 vs. 49 h; p = 0.08), or readmission within 30 days (1 vs. 4; p = 0.22). The vitamin C doses given were safe, well tolerated and saturating. A randomised controlled trial to assess the efficacy of vitamin C in patients with CAP would require 932 participants (CURB-65 ≥ 2) to observe a difference in mortality and 200 participants to observe a difference with a composite endpoint such as mortality plus discharge after 7 days in hospital. These studies are feasible in a multicentre setting.

Hypothalamic Reactivity and Connectivity following Intravenous Glucose Administration.

Dysfunctional glucose sensing in homeostatic brain regions such as the hypothalamus is interlinked with the pathogenesis of obesity and type 2 diabetes mellitus. However, the physiology and pathophysiology of glucose sensing and neuronal homeostatic regulation remain insufficiently understood. To provide a better understanding of glucose signaling to the brain, we assessed the responsivity of the hypothalamus (i.e., the core region of homeostatic control) and its interaction with mesocorticolimbic brain regions in 31 normal-weight, healthy participants. We employed a single-blind, randomized, crossover design of the intravenous infusion of glucose and saline during fMRI. This approach allows to investigate glucose signaling independent of digestive processes. Hypothalamic reactivity and connectivity were assessed using a pseudo-pharmacological design and a glycemia-dependent functional connectivity analysis, respectively. In line with previous studies, we observed a hypothalamic response to glucose infusion which was negatively related to fasting insulin levels. The observed effect size was smaller than in previous studies employing oral or intragastric administration of glucose, demonstrating the important role of the digestive process in homeostatic signaling. Finally, we were able to observe hypothalamic connectivity with reward-related brain regions. Given the small amount of glucose employed, this points toward a high responsiveness of these regions to even a small energy stimulus in healthy individuals. Our study highlights the intricate relationship between homeostatic and reward-related systems and their pronounced sensitivity to subtle changes in glycemia.

Recurrent Reversible Stroke-Like Encephalopathy After 5-Fluorouracil (5-FU) Chemotherapy: A Case Report and Literature Review.

BACKGROUND Chemotherapy based on 5-fluorouracil (5-FU) is a well-established treatment for solid cancers, including metastatic or advanced colon cancer. Despite its efficacy, 5-FU can cause rare but serious adverse events such as acute neurotoxicity, which presents as symptoms similar to stroke. CASE REPORT We report the case of a patient who was diagnosed with stage IV colorectal cancer and who underwent chemotherapy with a high dose of 5-FU as part of the FOLFIRI (Folinic Acid, Fluorouracil, Irinotecan) treatment plan. During the seventh, eighth, and ninth cycles of chemotherapy, the patient suffered from severe encephalopathy, and the cause of this condition was determined to the 46-hour continuous intravenous infusion of 5-FU, which was part of the FOLFIRI regimen. CONCLUSIONS 5-FU-induced hyperammonemic encephalopathy is a rare but serious adverse event that requires immediate recognition and treatment. The first step in managing this condition is to halt the 5-FU infusion and provide the patient with high volumes of fluid. Although most cases of 5-FU-induced encephalopathy resolve spontaneously, recurrence is possible if the drug is re-administered to the same patient. Therefore, it is crucial for healthcare providers to closely monitor patients receiving 5-FU chemotherapy and be aware of the signs and symptoms of hyperammonemic encephalopathy. Early intervention can prevent further complications and ensure the best possible outcome for the patient. It is important to note that while 5-FU-induced hyperammonemic encephalopathy is rare, it highlights the importance of closely monitoring patients receiving chemotherapy to identify and treat adverse events promptly. This can help improve patient outcomes and prevent serious long-term complications.

Safety and performance of intravenous pumps and syringe drivers in hyperbaric environments.

INTRODUCTION: Critically ill patients require continuation of their care when receiving hyperbaric oxygen treatment. This care may be facilitated via portable electrically powered devices such as intravenous (IV) infusion pumps and syringe drivers, which may create risks in the absence of a comprehensive safety evaluation. We reviewed published safety data for IV infusion pumps and powered syringe drivers in hyperbaric environments and compared the evaluation processes to key requirements documented in safety standards and guidelines. METHODS: A systematic literature review was undertaken to identify English language papers published in the last 15 years, describing the safety evaluations of IV pumps and/or syringe drivers for use in hyperbaric environments. Papers were critically assessed in relation to the requirements of international standards and safety recommendations. RESULTS: Eight studies of IV infusion devices were identified. There were deficiencies in the published safety evaluations of IV pumps for hyperbaric use. Despite a simple, published process for evaluating new devices, and available guidelines for fire safety, only two devices had comprehensive safety assessments. Most studies focused only on whether the device functioned normally under pressure and did not consider implosion/explosion risk, fire safety, toxicity, oxygen compatibility or risk of pressure damage. CONCLUSIONS: Intravenous infusion (and other electrically powered) devices require comprehensive assessment before use under hyperbaric conditions. This would be enhanced by a publicly accessible database hosting the risk assessments. Facilities should conduct their own assessments specific to their environment and practices.

Compatibility of calcium chloride with milrinone, epinephrine, vasopressin, and heparin via in vitro testing and simulated Y-site administration.

PURPOSE: The purpose of this study is to evaluate calcium chloride (CaCl) compatibility with commercially available and extemporaneously compounded milrinone, vasopressin, epinephrine, and heparin. This report describes 2 clinical scenarios in which patients experienced intravenous catheter precipitation when receiving multiple continuous infusions, including CaCl, and the results of an in vitro simulation of those scenarios. The hypothesis was that one or a combination of the medications would precipitate with CaCl. METHODS: CaCl compatibility was tested in 3 stages to simulate clinical situations where line precipitation occurred. Multiple tests were conducted in each stage to determine if precipitation had occurred, including visual assessment, absorbance measurement at 650 nm, and pH measurement. First, milrinone, vasopressin, epinephrine, and heparin were mixed pairwise with CaCl in a test tube. Second, the medications were mixed in different combinations deemed likely to precipitate. Finally, 5 medications were infused via simulated Y-site administration. Incompatibility was defined as observed crystals, haziness, or turbidity upon visual inspection or absorbance of greater than 0.01 absorbance unit (AU). All solutions were tested at time 0 and at 20, 60, 240, and 1,440 minutes. RESULTS: Across all tests, only a commercially available formulation of heparin 2 units/mL in 0.9% sodium chloride injection precipitated with CaCl, alone or in combination with other medications. Upon further review, it was found that this specific formulation of heparin contained a monohydrate and dibasic sodium phosphate buffer. CONCLUSION: CaCl only precipitated with a commercially available heparin formulation that contained a phosphate buffer. CaCl was deemed to be compatible with all other medications and formulations tested.

Efficacy and safety of intravenous iron sucrose in children younger than 2 years with intestinal failure.

Iron-deficiency anemia (IDA) is highly prevalent in children with intestinal failure (IF) and oral iron supplementation is often ineffective in this patient population. Even though various intravenous (IV) iron formulations are available, there is a dearth of data on the use of newer parenteral iron products such as IV iron sucrose, especially in infants and young children (<2 years of age) with IF. To determine safety and efficacy, we performed a retrospective chart review on infants and children younger than 2 years with IF who received IV iron sucrose for IDA between October 2019 and August 2021. The review revealed that 10 events of IV iron sucrose replacement were administered to five children aged 4-22 months with IF and IDA. We observed a mean increase in hemoglobin of 1.9 ± 0.6 g/dl, and peak hemoglobin levels were seen at 4.3 ± 0.8 weeks after the IV iron sucrose dose. The infusions were well tolerated, and no short-term adverse reactions or laboratory abnormalities were observed. Based on these observations, the use of IV iron sucrose appears to be safe and effective in infants and young children with IF and could be considered in the management of IDA in this patient population.

Midwives' perspectives of intravenous fluid management and fluid balance documentation in labour: A qualitative reflexive thematic analysis study.

AIM: To describe current practice, examine the influences and explore barriers and facilitators to accurate documentation, for the administration of intravenous fluids during labour. DESIGN: A descriptive qualitative study was performed. METHODS: Qualitative semi-structured interviews were conducted with Registered Midwives working across Australia. Midwives were recruited via email and social media advertisements. A maximum variation sampling strategy was used to identify potential participants. Interview questions explored four main areas: (i) understanding of indications for IV fluids in labour; (ii) identification of current practice; (iii) barriers to documentation and (iv) benefits and complications of IV fluid administration. Reflexive thematic analysis of recorded-transcribed interviews was conducted. RESULTS: Eleven midwives were interviewed. Clinical practice variation across Australia was recognized. Midwives reported a potential risk of harm for women and babies and a current lack of evidence, education and clinical guidance contributing to uncertainty around the use of IV fluids in labour. Overall, eight major themes were identified: (i) A variable clinical practice; (ii) Triggers and habits; (iii) Workplace and professional culture; (iv) Foundational knowledge; (v) Perception of risk; (vi) Professional standards and regulations; (vii) The importance of monitoring maternal fluid balance and (viii) barriers and facilitators to fluid balance documentation. CONCLUSION: There was widespread clinical variation identified and midwives reported a potential risk of harm. The major themes identified will inform future quantitative research examining the impact of IV fluids in labour. IMPACT: The implications of this research are important and potentially far-reaching. The administration of IV fluids to women in labour is a common clinical intervention. However, there is limited evidence available to guide practice. This study highlights the need for greater education and evidence examining maternal and neonatal outcomes to provide improved clinical guidance.

A Standardized Training Program in Ultrasound-Guided Intravenous Line Placement: Improving Nurses' Confidence and Success.

BACKGROUND: Ultrasound-guided imagery to obtain peripheral intravenous (USGIV) access is a technique that can be used to increase successful peripheral intravenous catheter insertion rates. Improving rates of USGIV use will subsequently decrease central venous catheter use and thus decrease the time to treatment initiation, reduce costs, and improve patient satisfaction. PURPOSE: Current available programs teach nurses USGIV use for the adult population, mainly with a focus on the emergency department. To address this gap in knowledge, a USGIV program aimed at the specific needs of the neonatal intensive care unit (NICU) nurse was developed and implemented. METHOD: Twelve NICU nurses were trained in USGIV access during a 4-hour combination didactic and simulation-based program. Participants took a pretest survey assessing baseline knowledge and confidence levels related to USGIV access. After didactic lecture, participants worked at stations focused on USGIV access. An 80% benchmark for each participant was set for successful USGIV attempts during simulation. Participants' knowledge and confidence levels were reassessed at the end of the program. RESULTS: Posttest scores increased by an average of 25%, demonstrating increased knowledge. The pre- to posttest confidence scores increased by a minimum of 1.6 points (based on a 5-point Likert scale). All participants (n = 12) successfully demonstrated proficiency by achieving at least 80% of attempted USGIV access on a mannequin. IMPLICATIONS FOR PRACTICE AND RESEARCH: This project demonstrated that USGIV catheter can be employed in neonatal patients by training NICU nurses in USGIV techniques.

Physical compatibility of remimazolam with opioid analgesics, sedatives, and muscle relaxants during simulated Y-site administration.

PURPOSE: There is a lack of information on the compatibility of remimazolam with opioid analgesics, muscle relaxants, and other sedatives. This study aimed to evaluate the physical compatibility of remimazolam with these drug classes. METHODS: Remimazolam was combined with 1 or 2 target drugs (remifentanil, fentanyl, rocuronium, vecuronium, dexmedetomidine, and midazolam). Ten physical compatibility tests were conducted, including four 3-drug compatibility tests. Remimazolam was dissolved in 0.9% sodium chloride injection to a final concentration of 5 mg/mL. Other medications were diluted in 0.9% sodium chloride injection to obtain clinically relevant concentrations. Compatibility tests were conducted with 3 test solutions, wherein remimazolam and the target drugs were compounded at equal volume ratios (1:1 or 1:1:1). Visual appearance was assessed and testing of Tyndall effect, turbidity, and pH was performed immediately after mixing and then again 1 hour and 4 hours after mixing. Appearance and turbidity were evaluated by comparison with the control solution of each target drug diluted with 0.9% sodium chloride injection to the same concentration as the test solution. RESULTS: All drugs tested were determined to be compatible with remimazolam. The drug combination with the highest change of turbidity was remimazolam and vecuronium (a mean increase of 0.16 NTU relative to the remimazolam control solution), 4 hours after mixing. The combination with the highest pH was remimazolam, fentanyl, and vecuronium (mean [SD], 3.76 [0.01]), 4 hours after mixing. The combination of remimazolam and fentanyl showed a larger change in pH at 4 hours after mixing (a mean increase of 2.6%) than immediately after mixing. CONCLUSION: Remifentanil, fentanyl, rocuronium, vecuronium, dexmedetomidine, and midazolam are physically compatible with remimazolam during simulated Y-site administration.

Efficacy of high-dose intravenous iron in middle-aged to elderly iron-deficient patients.

Iron deficiency (ID) impacts about fifty percent of elderly patients with many symptoms present before iron deficiency anaemia . If left untreated, ID may increase morbidity and mortality. Oral iron is often not tolerated or the absorption is suboptimal. We describe our initial experiences of using high-dose intravenous ferric derisomaltose (Monofer®) infusions of 500 and 1000mg for iron deficiency and iron deficiency anaemia respectively in the outpatient setting. Rapid correction of laboratory parameters and improvement in common symptoms (such as fatigue) were observed. Intravenous iron may be an option for symptomatic iron deficient patients unsuitable for oral iron.

Simultaneous infusion of two incompatible antibiotics: Impact of the choice of infusion device and concomitant simulated fluid volume support on the particulate load and the drug mass flow rates.

Vancomycin and piperacillin/tazobactam are known to be incompatible. The objectives of the present study were to evaluate the impact of their simultaneous infusion on mass flow rates and particulate load and identify preventive strategies. We assessed both static conditions and a reproduction of an infusion line used in a hospital's critical care unit. A high-performance liquid chromatography/UV diode array system and static and dynamic laser diffraction particle counters were used. The mass flow rates were primarily influenced by the choice of the infusion device and the presence of simulated fluid volume support. Drug incompatibility also appeared to affect vancomycin's mass flow rate, and the dynamic particulate load increased during flow rate changes - especially in the infusion set with a large common volume line and no concomitant simulated fluid volume support. Only discontinuation of the piperacillin/tazobactam infusion was associated with a higher particulate load in the infusion set with a large common volume line and no concomitant simulated fluid volume support. A low common volume line and the use of simulated fluid volume support were associated with smaller fluctuations in the mass flow rate. The clinical risk associated with a higher particulate load must now be assessed.

Frequently acquired drugs in neonatal intensive care and their physical compatibility.

AIM: Incompatibility of intravenous drugs is dangerous and therefore undesirable. The aim of this study was to identify the most commonly acquired intravenous drugs in five neonatal intensive care units and test these for compatibility. METHODS: The most frequently acquired drugs in five key hospitals in the South-Eastern district of Norway for 2019 and 2020 served as a proxy for the prevalence of use. Representatives were selected from the three most prevalent groups based on the Anatomical Therapeutic Chemical classification system. Co-administration of drug pairs was simulated using clinically relevant concentrations and infusion rates representing mixing ratios in the catheter. Particle formation was assessed by particle counting and size measurement, by visual examination using Tyndall beam, by turbidity and by measuring pH of mixed samples. RESULTS: The most frequently acquired drug groups were anti-infectives, neurological agents and cardiovascular drugs. Compatibility testing revealed that both ampicillin and benzylpenicillin were incompatible with morphine. Flecainide and fluconazole showed no signs of incompatibility with morphine. No information on these combinations in a neonatal-relevant setting is available. CONCLUSION: We recommend to abstain from co-administering ampicillin and benzylpenicillin with morphine in neonatal intensive settings. Morphine co-administered with flecainide and fluconazole in neonatal patients were evaluated as safe.

Simulated Y-site compatibility of atosiban acetate with selected intravenous drugs.

OBJECTIVE: The physical compatibility of atosiban and selected drugs during simulated Y-site administration was evaluated. We also searched for any compatibility predictions regarding its physicochemical properties. STUDY DESIGN: Test admixtures were prepared by mixing 5 mL of each study drug solution with 5 mL of atosiban solution in a 1:1 ratio to simulate Y-site infusion. Assessments were made immediately after mixing (baseline), and at 0.5, 1, and 3 h. Visual incompatibility was defined as a presence of haze or any visible particulate matter, gas formation, or colour change. Turbidity and pH variation of the admixtures were also assessed using instrumental methods. RESULTS: None of the admixtures used with atosiban exhibited visual changes and no incompatibility regarding instrumental methods were observed, because no admixture had an increase of 0.5 nephelometric turbidity units, and no pH change was above one unit when compared to baseline. However, the pH of ampicillin and omeprazole admixtures fell outside of the atosiban stability range. CONCLUSIONS: Our study showed no physical incompatibility between atosiban and the test drugs in terms of visual changes or nephelometric and pH measurements. However, we recommend against atosiban and ampicillin or omeprazole coadministration until complementary compatibility studies are performed.