OBJECTIVE: Early hypoglycaemia at the time of neonatal intensive care unit (NICU) admission is common in very/extreme preterm infants. This study aimed to determine whether buccal dextrose gel in the delivery room (DR) would improve rates of early hypoglycaemia in this population. DESIGN: Randomised, blinded, placebo-controlled trial. SETTING: Four level-3 and one level-2 neonatal units. PATIENTS: Inborn infants≤32+0 weeks gestational age (GA). INTERVENTIONS: Infants were randomised to 40% dextrose or placebo gel in the DR (≤29+0 GA: 0.5 mL gel, ≥29+1 GA: 1 mL gel). MAIN OUTCOME MEASURE: Hypoglycaemia (<1.8 mmol/L) measured at the time of first intravenous access at NICU admission. RESULTS: Between November 2020 and August 2022, the recruitment rate was slow (impacted by the requirement for antenatal consent). This fact, coupled with finite research resources, led to a decision to end recruitment early. Data analysis of 169 newborns (33% of target sample size) showed no significant difference in the frequency of the primary outcome between dextrose 24/84 (29%) and placebo 25/85 (29%) groups (OR 0.95; 95% CI 0.49 to 1.86; p=0.88). A post-hoc analysis indicated that the trial had a low (47% conditional power) chance of detecting a statistically significant benefit from the intervention (had the target sample been achieved). CONCLUSIONS: This study showed no evidence of benefit of 40% dextrose gel on rates of hypoglycaemia at NICU admission. Management of these vulnerable newborns should continue to focus on vascular access and commencement of dextrose-containing intravenous fluids as early as possible. TRIAL REGISTRATION NUMBER: NCT04353713.

• MeSH
• Administration, Buccal MeSH
• Gels MeSH
• Gestational Age MeSH
• Glucose * administration & dosage   MeSH
• Hypoglycemia * drug therapy   prevention & control   MeSH
• Intensive Care Units, Neonatal MeSH
• Blood Glucose analysis   MeSH
• Humans MeSH
• Infant, Premature, Diseases * drug therapy   MeSH
• Infant, Premature MeSH
• Infant, Newborn MeSH
• Delivery Rooms MeSH
• Sweetening Agents administration & dosage   MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Infant, Newborn MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Randomized Controlled Trial MeSH

BACKGROUND: The CLASSIC trial assessed the effects of restrictive versus standard intravenous (IV) fluid therapy in adult intensive care unit (ICU) patients with septic shock. This pre-planned study provides a probabilistic interpretation and evaluates heterogeneity in treatment effects (HTE). METHODS: We analysed mortality, serious adverse events (SAEs), serious adverse reactions (SARs) and days alive without life-support within 90 days using Bayesian models with weakly informative priors. HTE on mortality was assessed according to five baseline variables: disease severity, vasopressor dose, lactate levels, creatinine values and IV fluid volumes given before randomisation. RESULTS: The absolute difference in mortality was 0.2%-points (95% credible interval: -5.0 to 5.4; 47% posterior probability of benefit [risk difference <0.0%-points]) with restrictive IV fluid. The posterior probabilities of benefits with restrictive IV fluid were 72% for SAEs, 52% for SARs and 61% for days alive without life-support. The posterior probabilities of no clinically important differences (absolute risk difference ≤2%-points) between the groups were 56% for mortality, 49% for SAEs, 90% for SARs and 38% for days alive without life-support. There was 97% probability of HTE for previous IV fluid volumes analysed continuously, that is, potentially relatively lower mortality of restrictive IV fluids with higher previous IV fluids. No substantial evidence of HTE was found in the other analyses. CONCLUSION: We could not rule out clinically important effects of restrictive IV fluid therapy on mortality, SAEs or days alive without life-support, but substantial effects on SARs were unlikely. IV fluids given before randomisation might interact with IV fluid strategy.

• MeSH
• Bayes Theorem MeSH
• Adult MeSH
• Intensive Care Units MeSH
• Humans MeSH
• Randomized Controlled Trials as Topic MeSH
• Shock, Septic * therapy   MeSH
• Fluid Therapy MeSH
• Check Tag
• Adult MeSH
• Humans MeSH
• Publication type
• Journal Article MeSH

BACKGROUND: Heterotopic pancreas is defined as pancreatic tissue located outside the pancreatic parenchyma that lacks an anatomic or vascular connection to the normal pancreas. Symptomatic gastric heterotopic pancreas is a rare condition that can manifest as acute or chronic pancreatitis. Asymptomatic heterotopic pancreas does not require treatment, while symptomatic lesions should be resected. The modality of final resection of heterotopic pancreas depends on its size and the depth of gastric wall involvement. METHODS AND RESULTS: A 36-year-old woman was admitted for recurrent epigastralgia. Abdominal computed tomography (CT) scan revealed that an abscess had formed in the gastric antrum. After multidisciplinary discussion we decided for conservative treatment with intravenous antibiotics and further detailed endoscopic diagnostic. Esophagogastroduodenoscopy revealed a submucosal mass with a central fistula and intermittent pus secretion in the prepyloric region of the gastric antrum, which was subsequently drained with a double pigtail stent under endoscopic ultrasound (EUS) and fluoroscopy. The possibility of pancreatic fluid collection in the case of heterotopic pancreas was suggested during the EUS examination, and histology subsequently confirmed heterotopic pancreatic tissue. The patient was in good condition and without any abdominal pain. According to a control CT scan after 10 weeks, the fluid collection was completely resolved. Due to the possible recurrence of pancreatitis, resection of heterotopic pancreas was proposed to the patient. Since the lesion involved the muscularis propria of the gastric wall, surgical resection of the mass was indicated. CONCLUSION: Fluid collections after acute pancreatitis in heterotopic pancreas in the gastric antrum can be successfully managed by endoscopy.

• MeSH
• Acute Disease MeSH
• Adult MeSH
• Endoscopy MeSH
• Endosonography MeSH
• Humans MeSH
• Pancreas MeSH
• Pancreatitis * surgery   MeSH
• Check Tag
• Adult MeSH
• Humans MeSH
• Female MeSH
• Publication type
• Case Reports MeSH

BACKGROUND: Idiopathic bleeding in the second trimester of pregnancy complicates <1% of all pregnancies. This pregnancy complication can be caused by alterations in local hemostasis in the decidua due to infection/inflammation in the choriodecidual niche. This condition is associated with intraamniotic inflammatory complications. Antibiotic therapy effectively reduces the intensity of intraamniotic inflammation in certain pregnancy pathologies. However, whether antibiotic administration can reduce the intensity of the intraamniotic inflammatory response or eradicate microorganisms in patients with idiopathic bleeding during the second trimester of pregnancy remains unclear. OBJECTIVE: This study primarily aimed to determine whether antimicrobial agents can reduce the magnitude of intraamniotic inflammation in patients with idiopathic bleeding in the second trimester of pregnancy by assessing the concentration of interleukin-6 in the amniotic fluid before and after 7 days of antibiotic treatment. The secondary aim was to determine whether treatment with a combination of antibiotics altered the microbial load of Ureaplasma species DNA in amniotic fluid. STUDY DESIGN: This retrospective cohort study included singleton-gestation patients with idiopathic bleeding between 15+0 and 27+6 weeks who underwent transabdominal amniocentesis at the time of admission. Follow-up amniocentesis was performed in a subset of patients unless abortion or delivery occurred earlier. Concentrations of interleukin-6 were measured in the amniotic fluid samples, and the presence of microbial invasion of the amniotic cavity was assessed using culture and molecular microbiological methods. Intraamniotic inflammation was defined as an interleukin-6 concentration ≥3000 pg/mL in the amniotic fluid samples. RESULTS: A total of 36 patients with idiopathic bleeding in the second trimester of pregnancy were included. All the patients underwent initial amniocentesis. Patients with intraamniotic inflammation (n=25) were treated using a combination of antibiotics consisting of intravenous ceftriaxone, intravenous metronidazole, and peroral clarithromycin. The patients without intraamniotic inflammation (n=11) were treated expectantly. In total, 25 patients delivered 7 days after admission. All patients with intraamniotic inflammation at the initial amniocentesis who delivered after 7 days underwent follow-up amniocentesis. Treatment with antibiotics decreased the interleukin-6 concentration in the amniotic fluid at follow-up amniocentesis compared with that at the initial amniocentesis in patients with intraamniotic inflammation (median [interquartile range]: 3457 pg/mL [2493-13,203] vs 19,812 pg/mL [11,973-34,518]; P=.0001). Amniotic fluid samples with Ureaplasma species DNA had a lower microbial load at the time of follow-up amniocentesis compared with the initial amniocentesis (median [interquartile range]: 1.5×105 copies DNA/mL [1.3×105-1.7×105] vs 8.0×107 copies DNA/mL [6.7×106-1.6×108]; P=.02). CONCLUSION: Antibiotic therapy was associated with reduced intraamniotic inflammation in patients with idiopathic bleeding in the second trimester complicated by intraamniotic inflammation. Moreover, antibiotic treatment has been associated with a reduction in the microbial load of Ureaplasma species DNA in the amniotic fluid.

• MeSH
• Amniocentesis adverse effects   MeSH
• Anti-Bacterial Agents therapeutic use   MeSH
• Chorioamnionitis * microbiology   MeSH
• Uterine Hemorrhage MeSH
• DNA MeSH
• Pregnancy Trimester, Second MeSH
• Interleukin-6 MeSH
• Humans MeSH
• Amniotic Fluid microbiology   MeSH
• Fetal Membranes, Premature Rupture * drug therapy   MeSH
• Retrospective Studies MeSH
• Pregnancy MeSH
• Ureaplasma MeSH
• Inflammation complications   MeSH
• Check Tag
• Humans MeSH
• Pregnancy MeSH
• Female MeSH
• Publication type
• Journal Article MeSH

Volume depletion is a common condition and a frequent cause of hospitalization in children. Proper assessment of the patient includes a detailed history and a thorough physical examination. Biochemical tests may be useful in selected cases. Understanding the pathophysiology of fluid balance is necessary for appropriate management. A clinical dehydration scale assessing more physical findings may help to determine dehydration severity. Most dehydrated children can be treated orally; however, intravenous therapy may be indicated in patients with severe volume depletion, in those who have failed oral therapy, or in children with altered consciousness or significant metabolic abnormalities. Proper management consists of restoring circulatory volume and electrolyte balance. In this paper, we review clinical aspects, diagnosis, and management of children with volume depletion.

• MeSH
• Dehydration * diagnosis   etiology   therapy   MeSH
• Child MeSH
• Physical Examination MeSH
• Humans MeSH
• Fluid Therapy * adverse effects   MeSH
• Water-Electrolyte Balance MeSH
• Check Tag
• Child MeSH
• Humans MeSH
• Publication type
• Journal Article MeSH
• Review MeSH

Intra-abdominal infections (IAIs) are an important cause of morbidity and mortality in hospital settings worldwide. The cornerstones of IAI management include rapid, accurate diagnostics; timely, adequate source control; appropriate, short-duration antimicrobial therapy administered according to the principles of pharmacokinetics/pharmacodynamics and antimicrobial stewardship; and hemodynamic and organ functional support with intravenous fluid and adjunctive vasopressor agents for critical illness (sepsis/organ dysfunction or septic shock after correction of hypovolemia). In patients with IAIs, a personalized approach is crucial to optimize outcomes and should be based on multiple aspects that require careful clinical assessment. The anatomic extent of infection, the presumed pathogens involved and risk factors for antimicrobial resistance, the origin and extent of the infection, the patient's clinical condition, and the host's immune status should be assessed continuously to optimize the management of patients with complicated IAIs.

• MeSH
• Anti-Bacterial Agents therapeutic use   MeSH
• Humans MeSH
• Intraabdominal Infections * drug therapy   MeSH
• Risk Factors MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Review MeSH

AIMS/HYPOTHESIS: The aim of this substudy (Eudra CT No:2019-001997-27)was to assess ATB availability in patients with infected diabetic foot ulcers(IDFUs)in the context of microcirculation and macrocirculation status. METHODS: For this substudy, we enrolled 23 patients with IDFU. Patients were treated with boluses of amoxicillin/clavulanic acid(AMC)(12patients) or ceftazidime(CTZ)(11patients). After induction of a steady ATB state, microdialysis was performed near the IDFU. Tissue fluid samples from the foot and blood samples from peripheral blood were taken within 6 hours. ATB potential efficacy was assessed by evaluating the maximum serum and tissue ATB concentrations(Cmax and Cmax-tissue)and the percentage of time the unbound drug tissue concentration exceeds the minimum inhibitory concentration (MIC)(≥100% tissue and ≥50%/60% tissue fT>MIC). Vascular status was assessed by triplex ultrasound, ankle-brachial and toe-brachial index tests, occlusive plethysmography comprising two arterial flow phases, and transcutaneous oxygen pressure(TcPO2). RESULTS: Following bolus administration, the Cmax of AMC was 91.8 ± 52.5 μgmL-1 and the Cmax-tissue of AMC was 7.25 ± 4.5 μgmL-1(P<0.001). The Cmax for CTZ was 186.8 ± 44.1 μgmL-1 and the Cmax-tissue of CTZ was 18.6 ± 7.4 μgmL-1(P<0.0001). Additionally, 67% of patients treated with AMC and 55% of those treated with CTZ achieved tissue fT>MIC levels exceeding 50% and 60%, respectively. We observed positive correlations between both Cmax-tissue and AUCtissue and arterial flow. Specifically, the correlation coefficient for the first phase was r=0.42; (P=0.045), and for the second phase, it was r=0.55(P=0.01)and r=0.5(P=0.021). CONCLUSIONS: Bactericidal activity proved satisfactory in only half to two-thirds of patients with IDFUs, an outcome that appears to correlate primarily with arterial flow.

• MeSH
• Anti-Bacterial Agents * pharmacokinetics   administration & dosage   therapeutic use   MeSH
• Diabetic Foot * drug therapy   metabolism   MeSH
• Administration, Intravenous MeSH
• Middle Aged MeSH
• Humans MeSH
• Microcirculation * drug effects   MeSH
• Aged MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH

PURPOSE: The aim of this study was to examine the effects of intravenous (IV) fluid restriction on time to resolution of hyperlactatemia in septic shock. Hyperlactatemia in sepsis is associated with worse outcome. Sepsis guidelines suggest targeting lactate clearance to guide fluid therapy despite the complexity of hyperlactatemia and the potential harm of fluid overload. METHODS: We conducted a post hoc analysis of serial plasma lactate concentrations in a sub-cohort of 777 patients from the international multicenter clinical CLASSIC trial (restriction of intravenous fluids in intensive care unit (ICU) patients with septic shock). Adult ICU patients with septic shock had been randomized to restrictive (n = 385) or standard (n = 392) intravenous fluid therapy. The primary outcome, time to resolution of hyperlactatemia, was analyzed with a competing-risks regression model. Death and discharge were competing outcomes, and administrative censoring was imposed 72 h after randomization if hyperlactatemia persisted. The regression analysis was adjusted for the same stratification variables and covariates as in the original CLASSIC trial analysis. RESULTS: The hazard ratios (HRs) for the cumulative probability of resolution of hyperlactatemia, in the restrictive vs the standard group, in the unadjusted analysis, with time split, were 0.94 (confidence interval (CI) 0.78-1.14) at day 1 and 1.21 (0.89-1.65) at day 2-3. The adjusted analyses were consistent with the unadjusted results. CONCLUSION: In this post hoc retrospective analysis of a multicenter randomized controlled trial (RCT), a restrictive intravenous fluid strategy did not seem to affect the time to resolution of hyperlactatemia in adult ICU patients with septic shock.

• MeSH
• Time Factors MeSH
• Hyperlactatemia * etiology   MeSH
• Intensive Care Units * statistics & numerical data   MeSH
• Lactic Acid blood   MeSH
• Middle Aged MeSH
• Humans MeSH
• Aged MeSH
• Shock, Septic * therapy   complications   blood   mortality   MeSH
• Fluid Therapy * methods   standards   MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Randomized Controlled Trial MeSH

BACKGROUND: Variation in usual practice in fluid trials assessing lower versus higher volumes may affect overall comparisons. To address this, we will evaluate the effects of heterogeneity in treatment intensity in the Conservative versus Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care trial. This will reflect the effects of differences in site-specific intensities of standard fluid treatment due to local practice preferences while considering participant characteristics. METHODS: We will assess the effects of heterogeneity in treatment intensity across one primary (all-cause mortality) and three secondary outcomes (serious adverse events or reactions, days alive without life support and days alive out of hospital) after 90 days. We will classify sites based on the site-specific intensity of standard fluid treatment, defined as the mean differences in observed versus predicted intravenous fluid volumes in the first 24 h in the standard-fluid group while accounting for differences in participant characteristics. Predictions will be made using a machine learning model including 22 baseline predictors using the extreme gradient boosting algorithm. Subsequently, sites will be grouped into fluid treatment intensity subgroups containing at least 100 participants each. Subgroups differences will be assessed using hierarchical Bayesian regression models with weakly informative priors. We will present the full posterior distributions of relative (risk ratios and ratios of means) and absolute differences (risk differences and mean differences) in each subgroup. DISCUSSION: This study will provide data on the effects of heterogeneity in treatment intensity while accounting for patient characteristics in critically ill adult patients with septic shock. REGISTRATIONS: The European Clinical Trials Database (EudraCT): 2018-000404-42, ClinicalTrials. gov: NCT03668236.

• MeSH
• Bayes Theorem MeSH
• Humans MeSH
• Critical Care methods   MeSH
• Shock, Septic * therapy   MeSH
• Machine Learning MeSH
• Fluid Therapy * methods   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH

Albumín je najvýznamnejším proteínom plazmy. Hypoalbuminémia u kriticky chorých novorodencov vzniká v dôsledku zníženej syntézy, zvýšených strát alebo redistribúcie albumínu. Intravenózna liečba exogénnym albumínom sa u novorodencov ordinuje v prípadoch hyperbilirubinémie, hypovolémie, hypoalbuminémie alebo v stavoch spojených so stratami bielkovín. Mnohokrát je jej podanie nevhodné a môže viesť k nežiaducim účinkom ako napríklad k objemovému preťaženiu, neurologickému alebo renálnemu poškodeniu. V súčasnosti sa podanie albumínu neodporúča v liečbe hyperbilirubinémie, objemovej resuscitácie v pôrodnej sále ani v rutinnej liečbe hypoalbuminémie u nedonosených novorodencov.

Use of albumin in newborns Albumin is the most important plasma protein. Hypoalbuminemia in critically ill newborn infants occurs due to reduced synthesis, increased losses or redistribution of albumin. Intravenous treatment with exogenous albumin is administered in newborns in cases of hyperbilirubinemia, hypovolemia, hypoalbuminemia or in protein-losing states. However, its administration is often inappropriate and can be associated with possible harms such as fluid overload, neurological injury, or renal injury. Currently, albumin administration is not recommended in the treatment of neonatal hyperbilirubinemia, volume resuscitation in the delivery room, or in the routine treatment of hypoalbuminemia in preterm infants.