Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular or Subcutaneous Route in Participants Aged 65 Years and Older in Japan

This phase I/II, randomized, modified double-blind, multi-center study assessed the safety and immunogenicity of a high-dose Quadrivalent influenza vaccine (QIV-HD) in older adults (greater than or equal to [>=] 65 years).

开始日期2017-09-15

申办/合作机构

Sanofi Pasteur

[+1]

NCT01707602 / Completed临床1/2期IIT

Impact of Immunization Routes on the Immune Response to Influenza Vaccine

The project aims to evaluate the impact of skin routes of immunization (transcutaneous and intradermal vs intramuscular) on cellular and humoral responses to seasonal influenza vaccination in adults (18-45 years old).

开始日期2012-10-01

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

[+1]

NCT01752881 / Completed临床4期

Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HAI) at three weeks post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).

开始日期2012-08-01

申办/合作机构

国光生物科技股份有限公司

100 项与 Seasonal influenza virus vaccine intradermal (sanofi pasteur) 相关的临床结果

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100 项与 Seasonal influenza virus vaccine intradermal (sanofi pasteur) 相关的转化医学

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100 项与 Seasonal influenza virus vaccine intradermal (sanofi pasteur) 相关的专利（医药）

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项与 Seasonal influenza virus vaccine intradermal (sanofi pasteur) 相关的文献（医药）

2022-12-01·Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine

Prehospital fluid therapy in patients with suspected infection: a survey of ambulance personnel’s practice

Article

作者: Væggemose, Ulla ; Jensen, Arne Sylvester ; Meilandt, Carsten ; Jessen, Marie Kristine ; Jørgensen, Kristian Winther ; Bach, Allan ; Jensen, Marie Egebjerg ; Kirkegaard, Hans

AbstractBackgroundFluid therapy in patients with suspected infection is controversial, and it is not known whether fluid treatment administered in the prehospital setting is beneficial. In the absence of evidence-based guidelines for prehospital fluid therapy for patients with suspected infection, Emergency Medical Services (EMS) personnel are challenged on when and how to initiate such therapy. This study aimed to assess EMS personnel’s decision-making in prehospital fluid therapy, including triggers for initiating fluid and fluid volumes, as well as the need for education and evidence-based guidelines on prehospital fluid therapy in patients with suspected infection. MethodsAn online survey concerning fluid administration in prehospital patients with suspected infection was distributed to all EMS personnel in the Central Denmark Region, including ambulance clinicians and prehospital critical care anaesthesiologists (PCCA). The survey consisted of sections concerning academic knowledge, statements about fluid administration, triggers to evaluate patient needs for intravenous fluid, and clinical scenarios. ResultsIn total, 468/807 (58%) ambulance clinicians and 106/151 (70%) PCCA responded to the survey. Of the respondents, 73% (n = 341) of the ambulance clinicians and 100% (n = 106) of the PCCA felt confident about administering fluids to prehospital patients with infections. However, both groups primarily based their fluid-related decisions on “clinical intuition”. Ambulance clinicians named the most frequently faced challenges in fluid therapy as “Unsure whether the patient needs fluid” and “Unsure about the volume of fluid the patient needs”. The five most frequently used triggers for evaluating fluid needs were blood pressure, history taking, skin turgor, capillary refill time, and shock index, the last of which only applied to ambulance clinicians. In the scenarios, the majority administered 500 ml to a normotensive woman with suspected sepsis and 1000 ml to a woman with suspected sepsis-related hypotension. Moreover, 97% (n = 250) of the ambulance clinicians strongly agreed or agreed that they were interested in more education about fluid therapy in patients with suspected infection.ConclusionThe majority of ambulance clinicians and PCCA based their fluid administration on “clinical intuition”. They faced challenges deciding on fluid volumes and individual fluid needs. Thus, they were eager to learn more and requested research and evidence-based guidelines.

2022-10-01·Brain Circulation

Comparison and evaluation of two different crystalloids - Normal saline and plasmalyte in patients of traumatic brain injury undergoing craniotomy

Article

作者: Kamal, Kirti ; Bala, Renu ; Bansal, Teena ; Mundra, Anshul

BACKGROUND AND AIMS:Fluid therapy is one of the most important components of the management of patients with traumatic brain injury (TBI). The present study was planned to compare plasmalyte and normal saline (NS) in patients who underwent craniotomies for TBI in terms of their effects on acid–base equilibrium, renal functions, and coagulation profile.METHODS:Fifty patients of age 18–45 years of either sex, who underwent emergency craniotomy for TBI, were included in the study. The patients were randomized into two groups. Group P (n = 25) received isotonic balanced crystalloid (plasmalyte) and Group N (n = 25) received NS intraoperatively and postoperatively till 24 h after surgery.RESULTS:The pH was lower in Group N (P < 0.05) at different time points after surgery. Similarly, more patients in Group N had pH <7.3 (P < 0.05); while the rest of the metabolic parameters were comparable in the two groups. Blood urea and serum creatinine were higher in Group N. Coagulation profile was comparable in the two groups.CONCLUSION:Acid–base, electrolyte balance, and renal profile were better in patients receiving plasmalyte as compared to NS. Hence, it can be a wiser choice for fluid management in patients of TBI undergoing craniotomy.

2021-12-01·Annals of Intensive Care2区 · 医学

The effect of the volemic and cardiac status on brain oxygenation in patients with subarachnoid hemorrhage: a bi-center cohort study

2区 · 医学

ArticleOA

作者: Rass, Verena ; Helbok, Raimund ; Beer, Ronny ; Peluso, Lorenzo ; Kofler, Mario ; Hackl, Werner O ; Pfausler, Bettina ; Ianosi, Bogdan-Andrei ; Putnina, Lauma ; Gaasch, Max ; Lindner, Anna ; Bogossian, Elisa Gouvea ; Taccone, Fabio Silvio ; Schiefecker, Alois J

AbstractBackgroundFluid management in patients after subarachnoid hemorrhage (SAH) aims at the optimization of cerebral blood flow and brain oxygenation. In this study, we investigated the effects of hemodynamic management on brain oxygenation by integrating advanced hemodynamic and invasive neuromonitoring.MethodsThis observational cohort bi-center study included data of consecutive poor-grade SAH patients who underwent pulse contour cardiac output (PiCCO) monitoring and invasive neuromonitoring. Fluid management was guided by the transpulmonary thermodilution system and aimed at euvolemia (cardiac index, CI ≥ 3.0 L/min/m2; global end-diastolic index, GEDI 680–800 mL/m2; stroke volume variation, SVV < 10%). Patients were managed using a brain tissue oxygenation (PbtO2) targeted protocol to prevent brain tissue hypoxia (BTH, PbtO2 < 20 mmHg). To assess the association between CI and PbtO2 and the effect of fluid challenges on CI and PbtO2, we used generalized estimating equations to account for repeated measurements.ResultsAmong a total of 60 included patients (median age 56 [IQRs 47–65] years), BTH occurred in 23% of the monitoring time during the first 10 days since admission. Overall, mean CI was within normal ranges (ranging from 3.1 ± 1.3 on day 0 to 4.1 ± 1.1 L/min/m2 on day 4). Higher CI levels were associated with higher PbtO2 levels (Wald = 14.2; p < 0.001). Neither daily fluid input nor fluid balance was associated with absolute PbtO2 levels (p = 0.94 and p = 0.85, respectively) or the occurrence of BTH (p = 0.68 and p = 0.71, respectively). PbtO2 levels were not significantly different in preload dependent patients compared to episodes of euvolemia. PbtO2 increased as a response to fluid boluses only if BTH was present at baseline (from 13 ± 6 to 16 ± 11 mmHg, OR = 13.3 [95% CI 2.6–67.4], p = 0.002), but not when all boluses were considered (p = 0.154).ConclusionsIn this study a moderate association between increased cardiac output and brain oxygenation was observed. Fluid challenges may improve PbtO2 only in the presence of baseline BTH. Individualized hemodynamic management requires advanced cardiac and brain monitoring in critically ill SAH patients.

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03233217 (CTgov)	临床1/2期	流感病毒感染	175	QIV-SD by SC (Cohort 2: QIV-SD by SC)	簾遞廠網蓋膚獵鹹積選(夢淵餘鹹膚顧範鑰積範) = 鏇願糧餘夢獵繭鏇齋窪網蓋醖簾窪遞壓齋築衊 (遞壓夢壓觸鏇淵積醖觸, 鹽構鏇觸鑰膚廠鏇餘簾 ~ 網鑰鏇繭糧襯艱蓋鹽醖) 更多	-	2019-12-17
				QIV-HD by IM (Cohort 2: QIV-HD by IM)	壓夢齋獵蓋獵襯艱繭築(願鹽鑰窪夢鹽獵襯築糧) = 蓋夢鬱積遞遞糧醖構夢網襯顧獵壓築顧憲選膚 (膚餘淵艱憲製鬱製鑰範, 選積糧鏇鹹觸廠夢觸積 ~ 鑰範鹽構獵廠淵選壓憲) 更多