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32 result(s) for "Gul, Fethi"
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The safety and adverse event profile of favipiravir in the treatment of COVID-19 patients, Turkey
Introduction: Favipiravir (FVP) is an antiviral and used to treat COVID-19. We aimed to document the safety and adverse events associated with FVP on the outcome of COVID-19 treatment. Methodology: The study included 225 adult patients with moderate COVID-19 infection (World Health Organization scale-5). The adverse events (AEs) were evaluated using a grading scale supported by the Food and Drug Administration. Safety was assessed by the frequency of serious AEs. Results: The AEs associated with FVP treatment were hepatotoxicity (87/225, 38.7%), weakness (32/225, 14.2%), nephrotoxicity (26/225, 11.6%), nausea (18/225, 8.0%), diarrhea (8/225, 3.6%), vomiting (5/225, 2.2%), and insomnia (4/225, 1.8%); rash was not detected. Hepatotoxicity was observed more frequently in patients who also developed nephrotoxicity (57.7% vs 36.2%, p = 0.03). The deceased patients were significantly older and had higher prevalence of hypertension, congestive heart failure (CHF), coronary artery disease, cancer, nephrotoxicity. and angiotensin- converting enzyme inhibitors/angiotensin receptor blocker use. While male gender (OR: 5.38 CI: 1.64-17.67) and CHF (OR: 6.8 CI: 1.92-24.74) were significantly associated with nephrotoxicity, age (OR: 1.06 CI: 1.02-1.10), cancer (OR: 3.9 CI: 1.10-14.22) and nephrotoxicity (OR: 5.5 CI: 1.74-17.74) were associated with mortality. Conclusions: Serious AEs were detected at very low levels that would not require discontinuation of treatment or any AE-related death. Since SARS-CoV-2 itself and drug interactions may differ, FVP-related AEs might vary in COVID-19 patients. Our study shows that FVP can be used safely with a low AE profile. More extensive evidence is required to evaluate the long-term AEs of FVP.
Reduction of nosocomial infections in the intensive care unit using an electronic hand hygiene compliance monitoring system
Introduction: Healthcare-associated infection is an important cause of mortality and morbidity worldwide. Well-regulated infection control and hand hygiene are the most effective methods for preventing healthcare-associated infections. This study evaluated and compared conventional hand hygiene observation and an electronic hand-hygiene recording and reminder system for preventing healthcare-associated infections. Methodology: This pre- and post-intervention study, employed an electronic hand-hygiene recording and reminder system for preventing healthcare-associated infections at a tertiary referral center. Healthcare-associated infection surveillance was recorded in an anesthesia and reanimation intensive care unit from April 2016 to August 2016. Hand-hygiene compliance was observed by conventional observation and an electronic recording and reminder system in two consecutive 2-month periods. healthcare-associated infections were calculated as incidence rate ratios. Results: The rate of healthcare-associated infections in the electronic hand- hygiene recording and reminder system period was significantly decreased compared with that in the conventional hand-hygiene observation period (incidence rate ratio = 0.58; 95% confident interval = 0.33-0.98). Additionally, the rate of central line-associated bloodstream infections and the rate of ventilator-associated pneumonia were lower during the electronic hand hygiene recording and reminder system period (incidence rate ratio= 0.41; 95% confident interval = 0.11-1.30 and incidence rate ratio = 0.67; 95% confident interval = 0.30-1.45, respectively). Conclusions: After implementing the electronic hand hygiene recording and reminder system, we observed a significant decrease in healthcare-associated infections and invasive device-associated infections. These results were encouraging and suggested that electronic hand hygiene reminder and recording systems may reduce some types of healthcare-associated infections in healthcare settings.
Changing Definitions of Sepsis
Sepsis is one of the main causes of morbidity and mortality in critically ill patients despite the use of modern antibiotics and resuscitation therapies. Outcomes in sepsis have improved overall, probably because of an enhanced focus on early diagnosis and other improvements in supportive care, but mortality rates still remain unacceptably high. The diagnosis and definition of sepsis is a critical problem due to the heterogeneity of this disease process. Although it is apparent that much more needs to be done to advance our understanding, sepsis and related terms remain difficult to define. A 1991 consensus conference developed initial definitions that systemic inflammatory response syndrome (SIRS) to infection would be called sepsis. Definitions of sepsis and septic shock were revised in 2001 to incorporate the threshold values for organ damage. In early 2016, the new definitions of sepsis and septic shock have changed dramatically. Sepsis is now defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. The consensus document describes organ dysfunction as an acute increase in total Sequential Organ Failure Assessment (SOFA) score two points consequently to the infection. A significant change in the new definitions is the elimination of any mention of SIRS. The Sepsis-3 Task Force also introduced a new bedside index, called the qSOFA, to identify outside of critical care units patients with suspected infection who are likely to develop sepsis. Recently updated the consensus definitions improved specificity compared with the previous descriptions.
Current Trends in Hemoadsorption Treatment for Critically Ill Patients: are We Moving Forward?
In a retrospective cohort study, high-dose hemoadsorption (6 l/kg) improved the survival rate in patients with septic shock.5 In another single-center retrospective study, patients who underwent hemoadsorption therapy had lower mortality rates and catecholamine levels than those who did not undergo hemoadsorption.6 Furthermore, hemoadsorption of ticagrelor/rivaroxaban in patients undergoing emergency open-heart operations reportedly reduces the risk of bleeding complications.7 Saller et al.8 determined that hemoadsorption therapy in patients undergoing aortic surgery with hypothermic circulatory arrest reduced the vasopressor and transfusion requirements and improved the acid-base balance. There have been case reports and series about its use in patients following a trauma, indicating its potential benefits in avoiding further renal injury.9 Randomized controlled trials (RCTs), consensuses, and meta-analyses have determined that hemoadsorption is associated with improved dialysis complications, quality of life, and survival.10,11 Because COVID-19 worsens with marked severe systemic inflammation, there is significant scope for hemoadsorption studies in patients with COVID-19. [...]hemoadsorption is not used in routine clinical practice. Authorship Contributions:Concept- F.G., C.R.; Design- F.G., C.R.; Data Collection or Processing- F.G., C.R.; Analysis or Interpretation- F.G., C.R.; Literature Search- F.G., C.R.; Writing- F.G., C.R. Conflict of Interest: No conflict of interest was declared by the authors.
Turkish validity and reliability study of the Feeling Safe During Surgery Scale
[LANGUAGE= \"English\"] BACKGROUND: This study was conducted methodologically to evaluate the Turkish validity and reliability of the Feeling Safe During Surgery Scale and to assess its suitability for the Turkish population.METHODS: This methodological validity and reliability study collected data from 148 patients who underwent elective surgery with regional anesthesia in the general surgery clinics of a university hospital in Istanbul between December 1, 2021 and June 30, 2022. Data were obtained through face-to-face interviews with patients using the Patient Information Form, developed by the researchers based on the literature, and the Turkish version of the Feeling Safe During Surgery Scale, originally created in Swedish. The Statistical Package for the Social Sciences (SPSS) Amos 26 was used for data analysis.RESULTS: The content validity index of the scale was determined to be 0.96. Confirmatory factor analysis indicated that the Turkish version of the Feeling Safe During Surgery Scale was acceptably compatible with the original scale. The adapted Turkish version was found to have a comprehensible language structure and appropriate content. Cronbach's alpha coefficient for the total score was α=0.839, indicating a high level of reliability. Consequently, the Turkish version of the Feeling Safe During Surgery Scale was determined to be valid, reliable, and stable over time.CONCLUSION: The Turkish version of the Feeling Safe During Surgery Scale is a valid and reliable instrument that can be used in the Turkish population for assessing the sense of safety in patients undergoing elective surgery with regional anesthesia in surgical units.[LANGUAGE= \"Turkish\"] AMAÇ: Bu çalışma, “Ameliyat Sırasında Kendini Güvende Hissetme Ölçeği ”nin Türkçe geçerlilik ve güvenilirliğini değerlendirmek ve Türk toplumuna uygunluğunu incelemek amacıyla metodolojik olarak gerçekleştirilmiştir.GEREÇ VE YÖNTEM: Bu metodolojik geçerlik ve güvenirlik çalışmasının verileri 01 Aralık 2021 ve 30 Haziran 2022 tarihleri arasında İstanbul'daki bir üniversite hastanesinin genel cerrahi kliniklerinde bölgesel anestezi ile elektif cerrahi geçiren 148 hastadan toplanmıştır. Verilerin toplanmasında, araştırmacılar tarafından literatür doğrultusunda hazırlanan “Hasta Bilgi Formu” ve orjinali İsveççe olan “Ameliyat Sırasında Kendini Güvende Hissetme Ölçeği” ölçeğin Türkçe versiyonu aracılığıyla hastalarla yüz yüze görüşülerek elde edildi. Verilerin analizinde SPSS Amos 26 istatistiksel analiz programı kullanıldı.BULGULAR: Ölçeğin kapsam geçerlilik indeks değeri 0.96 olarak belirlendi. Doğrulayıcı faktör analizi, Ameliyat Sırasında Güvende Hissetme Ölçeği Türkçe formunun orijinal ölçekle kabul edilebilir düzeyde uyumlu olduğunu ortaya koydu. Türkçe'ye uyarlanan ölçeğin dil yapısının anlaşılır ve içeriğinin uygun olduğu belirlendi. Toplam puan için Cronbach alfa katsayısı α=0.839 olup yüksek güvenilirlik düzeyinde olarak değerlendirildi. Sonuç olarak, Ameliyat Sırasında Kendini Güvende Hissetme Ölçeği'nin Türkçe versiyonu geçerli, güvenilir ve zaman içinde değişmez olduğu belirlendi. SONUÇ: Ameliyat Sırasında Kendini Güvende Hissetme Ölçeği'nin Türkçe versiyonu, cerrahi birimlerde rejyonel anestezi ile elektif cerrahi geçiren hastaların cerrahi süreç boyunca kendilerini güvende hissetmelerini değerlendirmek için Türk toplumunda kullanılabilir geçerli ve güvenilir bir araçtır.
A pilot study for treatment of severe COVID-19 pneumonia by aerosolized formulation of convalescent human immune plasma exosomes (ChipEXO™)
This is a single-center prospective, open-label, single arm interventional study to test the safety and efficacy of recently described ChipEXO™ for severe COVID-19 pneumonia. The ChipEXO™ is a natural product derived from convalescent human immune plasma of patients recovered from moderate COVID-19 infection. In September 2021, 13 patients with pending respiratory failure were treated with ChipEXO™ adapted for aerosolized formulation delivered via jet nebulizer. Patients received 1-5x10 10 nano vesicle/5 mL in distilled water twice daily for five days as an add-on to ongoing conventional COVID-19 treatment. The primary endpoint was patient safety and survival over a 28-day follow-up. The secondary endpoint was longitudinal assessment of clinical parameters following ChipEXO™ to evaluate treatment response and gain insights into the pharmacodynamics. ChipEXO™ was tolerated well without any allergic reaction or acute toxicity. The survival rate was 84.6% and 11 out of 13 recovered without any sequel to lungs or other organs. ChipEXO™ treatment was effective immediately as shown in arterial blood gas analyses before and two hours after exosome inhalation. During the 5 days of treatment, there was a sustainable and gradual improvement on oxygenation parameters: i.e. respiratory rate (RR) [20.8% (P < 0.05)], oxygen saturation (SpO 2 ) [6,7% (P < 0.05)] and partial pressure of oxygen to the fraction of inspired oxygen (PaO 2 /FiO 2 ) [127.9% (P < 0.05)] that correlated with steep decrease in the disease activity scores and inflammatory markers, i.e. the sequential organ failure assessment (SOFA) score (75%, p < 0.05), C-reactive protein (46% p < 0.05), ferritin (58% p = 0.53), D-dimer (28% p=0.46). In conclusion, aerosolized ChipEXO™ showed promising safety and efficacy for life-threatening COVID-19 pneumonia. Further studies on larger patient populations are required to confirm our findings and understand the pathophysiology of improvement toward a new therapeutic agent for the treatment of severe COVID-19 pneumonia.
Preclinical Studies on Convalescent Human Immune Plasma-Derived Exosome: Omics and Antiviral Properties to SARS-CoV-2
The scale of the COVID-19 pandemic forced urgent measures for the development of new therapeutics. One of these strategies is the use of convalescent plasma (CP) as a conventional source for passive immunity. Recently, there has been interest in CP-derived exosomes. In this report, we present a structural, biochemical, and biological characterization of our proprietary product, convalescent human immune plasma-derived exosome (ChipEXO), following the guidelines set forth by the Turkish Ministry of Health and the Turkish Red Crescent, the Good Manufacturing Practice, the International Society for Extracellular Vesicles, and the Gene Ontology Consortium. The data support the safety and efficacy of this product against SARS-CoV-2 infections in preclinical models.
An outbreak investigation of Burkholderia cepacia infections related with contaminated chlorhexidine mouthwash solution in a tertiary care center in Turkey
Background We report a nosocomial outbreak caused by Burkholderia cepacia that occurred among six patients admitted in the medical and surgical intensive care unit between 04 March 2019 and 02 April 2019 in Istanbul, Turkey. Methods The outbreak investigation was launched on 11 March 2019 five days after the detection of B. cepacia in four different patients. We defined potential reservoirs and started environmental screening. We sampled the liquid solutions used in patient care activities. Pulse-field gel electrophoresis (PFGE) was performed to determine the genetic relatedness of environmental and patient samples. Results Burkholderia cepacia was isolated in tracheal aspiration cultures of six patients. Three out of six patients developed healthcare-associated pneumoniae due to B. cepacia . Environmental cultures in the ICUs revealed B. cepacia growth in 2% chlorhexidine-gluconate mouthwash solution that been used in the colonized patients as well as in samples obtained from the unused products. PFGE revealed the patient and a specific batch of chlorhexidine mouthwash solution samples had a 96% similarity. Conclusion Contamination of medical solutions used in critical patient care could cause outbreaks and should be detected early by infection control teams. Graphic abstract
Turkish validity and reliability study of the Feeling Safe During Surgery Scale/Ameliyat sirasinda kendini guvende hissetme olceginin turkce gecerlilik ve guvenilirlik calismasi
BACKGROUND: This study was conducted methodologically to evaluate the Turkish validity and reliability of the Feeling Safe During Surgery Scale and to assess its suitability for the Turkish population. METHODS: This methodological validity and reliability study collected data from 148 patients who underwent elective surgery with regional anesthesia in the general surgery clinics of a university hospital in Istanbul between December 1,2021 and June 30, 2022. Data were obtained through face-to-face interviews with patients using the Patient Information Form, developed by the researchers based on the literature, and the Turkish version of the Feeling Safe During Surgery Scale, originally created in Swedish. The Statistical Package for the Social Sciences (SPSS) Amos 26 was used for data analysis. RESULTS: The content validity index of the scale was determined to be 0.96. Confirmatory factor analysis indicated that the Turkish version of the Feeling Safe During Surgery Scale was acceptably compatible with the original scale. The adapted Turkish version was found to have a comprehensible language structure and appropriate content. Cronbach's alpha coefficient for the total score was [alpha] =0.839, indicating a high level of reliability. Consequently, the Turkish version of the Feeling Safe During Surgery Scale was determined to be valid, reliable, and stable over time. CONCLUSION: The Turkish version of the Feeling Safe During Surgery Scale is a valid and reliable instrument that can be used in the Turkish population for assessing the sense of safety in patients undergoing elective surgery with regional anesthesia in surgical units. Keywords: Feeling safe; reliability; surgery; validity. AMAC: Bu calisma, \"Ameliyat Sirasinda Kendini Guvende Hissetme Olcegi \"nin Turkce gecerlilik ve guvenilirligini degerlendirmek ve Turk toplumuna uygunlugunu incelemek amaciyla metodolojik olarak gerceklestirilmistir. GEREC VE YONTEM: Bu metodolojik gecerlik ve guvenirlik calismasinin verileri 01 Aralik 2021 ve 30 Haziran 2022 tarihleri arasinda Istanbul'daki bir universite hastanesinin genel cerrahi kliniklerinde bolgesel anestezi ile elektif cerrahi geciren 148 hastadan toplanmistir. Verilerin toplanmasinda, arastirmacilar tarafindan literatur dogrultusunda hazirlanan \"Hasta Bilgi Formu\" ve orjinali isvecce olan \"Ameliyat Sirasinda Kendini Guvende Hissetme Olcegi\" olcegin Turkce versiyonu araciligiyla hastalarla yuz yuze gorusulerek elde edildi. Verilerin analizinde SPSS Amos 26 istatistiksel analiz programi kullanildi. BULGULAR: Olcegin kapsam gecerlilik indeks degeri 0.96 olarak belirlendi. Dogrulayici faktor analizi, Ameliyat Sirasinda Guvende Hissetme Olcegi Turkce formunun orijinal olcekle kabul edilebilir duzeyde uyumlu oldugunu ortaya koydu. Turkce'ye uyarlanan olcegin dil yapisinin anlasilir ve iceriginin uygun oldugu belirlendi. Toplam puan icin Cronbach alfa katsayisi [alpha]=0.839 olup yuksek guvenilirlik duzeyinde olarak degerlendirildi. Sonuc olarak, Ameliyat Sirasinda Kendini Guvende Hissetme Olcegi'nin Turkce versiyonu gecerli, guvenilir ve zaman icinde degismez oldugu belirlendi. SONUC: Ameliyat Sirasinda Kendini Guvende Hissetme Olcegi'nin Turkce versiyonu, cerrahi birimlerde rejyonel anestezi ile elektif cerrahi geciren hastalarin cerrahi surec boyunca kendilerini guvende hissetmelerini degerlendirmek icin Turk toplumunda kullanilabilir gecerli ve guvenilir bir aractir. Anahtar sozcukler: Cerrahi; guvende hissetme; gecerlilik; guvenilirlik.