scholarly journals Comparison of Generic (Rolexan) and Brand (Clexan) Forms of Enoxaparin in Critically Ill Patients: A Cross Over, Open Label, Randomized Prospective Clinical Trial

Author(s):  
Shadi Ziaie ◽  
Hanieh Malekmohammadi ◽  
Mohammad Sistanizad

Backgrounds: Several generic forms of enoxaparin were introduced to the market after expiring the patent of Clexane. But the main problem with generic forms is its bio-equivalency with brand form as a little difference in active ingredients characteristics, could led to significant clinical differences. For evaluating the efficacy of enoxaparin, it is recommended to measure its activity against Anti Xa. The aim of this study was comparison of Anti Xa Activity of Enoxan® versus Clexane ® in critically ill patients with prophylactic doses. Methods: This was a cross over, open label, randomized prospective study which was performed between September 2016 and December 2017 in intensive care unit of Labbafinezhad hospital, Tehran, Iran. Thirty adult patients, who received enoxaparin for prophylaxis of thromboembolic events, were recruited. Subjects were subsequently randomized to one of the treatment sequences (Generic–brand or brand–generic). The generic drug was enoxaparin sodium 40 mg (4,000 IU anti-FXa/0.4 mL), manufactured by Ronakpharm, Iran; the brand drug was enoxaparin sodium 40 mg (Clexane® 4,000 IU anti-FXa/0.4 mL), manufactured by Sanofi, France. Results: Anti-Xa activity was assessed with Stago kit. The anti-Xa activity between 0.2 and 0.5 U/mL was defined as prophylaxis. The average Anti-Xa activities of Clexan and Rolexan were 0.3±0.12 and 0.22±0.10, respectively which reveals statistically no significant difference (P: 0.35). Also Anti-Xa activity in 6 and 11 patients in Clexan and Rolexan groups were under 0.2 (P: 0.16). Conclusion: Our study showed comparable efficacy of prophylactic doses between Clexan and Rolexan in critically ill patients. Further studies in different patient population are recommended. J Pharm Care 2020; 8(1): 23-25.

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Shenyun Shi ◽  
Yonglong Xiao ◽  
Xiaohua Qiu ◽  
Yan Li ◽  
Yuying Qiu ◽  
...  

AbstractThe study aimed to evaluate the clinical and imaging features of critically ill patients with interstitial lung disease (ILD) treated in respiratory intensive care unit (RICU) and assess the prognostic effects of these factors. A total of 160 severe ILD patients admitted to the RICU were finally enrolled in this study. The clinical, imaging and follow-up data of them were studied retrospectively. The in-hospital mortality and total mortality were 43.1% and 63.8% respectively. By multivariate cox regression analysis, shock (OR = 2.39, P = 0.004), pulmonary fibrosis on CT (OR = 2.85, P = 0.002) and non-invasive ventilation (OR = 1.86, P = 0.037) were harmful factors to survivals of critically ill patients with ILD. In contrast, oxygenation index (OR = 0.99, P = 0.028), conventional oxygen therapy (OR = 0.59, P = 0.048) and β-lactam antibiotics use (OR = 0.51, P = 0.004) were protective factors. There is significant difference of survivals between patients with and without fibrosing ILD on CT (Log-rank, p = 0.001). The prognosis of critically ill patients with ILD was poor. Shock, respiratory failure and fibrosing signs on chest CT affected the prognosis. Chest CT was considered as a valuable tool to indicate the prognosis.


Medicina ◽  
2021 ◽  
Vol 57 (7) ◽  
pp. 674
Author(s):  
Sjaak Pouwels ◽  
Dharmanand Ramnarain ◽  
Emily Aupers ◽  
Laura Rutjes-Weurding ◽  
Jos van Oers

Background and Objectives: The aim of this study was to investigate the association between obesity and 28-day mortality, duration of invasive mechanical ventilation and length of stay at the Intensive Care Unit (ICU) and hospital in patients admitted to the ICU for SARS-CoV-2 pneumonia. Materials and Methods: This was a retrospective observational cohort study in patients admitted to the ICU for SARS-CoV-2 pneumonia, in a single Dutch center. The association between obesity (body mass index > 30 kg/m2) and 28-day mortality, duration of invasive mechanical ventilation and length of ICU and hospital stay was investigated. Results: In 121 critically ill patients, pneumonia due to SARS-CoV-2 was confirmed by RT-PCR. Forty-eight patients had obesity (33.5%). The 28-day all-cause mortality was 28.1%. Patients with obesity had no significant difference in 28-day survival in Kaplan–Meier curves (log rank p 0.545) compared with patients without obesity. Obesity made no significant contribution in a multivariate Cox regression model for prediction of 28-day mortality (p = 0.124), but age and the Sequential Organ Failure Assessment (SOFA) score were significant independent factors (p < 0.001 and 0.002, respectively). No statistically significant correlation was observed between obesity and duration of invasive mechanical ventilation and length of ICU and hospital stay. Conclusion: One-third of the patients admitted to the ICU for SARS-CoV-2 pneumonia had obesity. The present study showed no relationship between obesity and 28-day mortality, duration of invasive mechanical ventilation, ICU and hospital length of stay. Further studies are needed to substantiate these findings.


2021 ◽  
Author(s):  
Athanasios Chalkias ◽  
Ioannis Pantazopoulos ◽  
Nikolaos Papagiannakis ◽  
Anargyros Skoulakis ◽  
Eleni Laou ◽  
...  

AbstractRationaleThe progress of COVID-19 from moderate to severe may be precipitous, while the heterogenous characteristics of the disease pose challenges to the management of these patients.ObjectivesTo characterize the clinical course and outcomes of critically ill patients with COVID-19 during two successive waves.MethodsWe leveraged the multi-center SuPAR in Adult Patients With COVID-19 (SPARCOL) study and collected data from consecutive patients requiring admission to the intensive care unit from April 1st to December 31st, 2020.Measurements and Main ResultsOf 252 patients, 81 (32%) required intubation and mechanical ventilation. Of them, 17 (20.9%) were intubated during the first wave, while 64 (79%) during the second wave. The most prominent difference between the two waves was the overall survival (first wave 58.9% vs. second wave 15.6%, adjusted p-value=0.006). This difference is reflected in the prolonged hospitalization during the first wave. The mean ICU length of stay (19.1 vs. 11.7 days, p=0.022), hospital length of stay (28.5 vs. 17.1 days, p=0.012), and days on ventilator (16.7 vs. 11.5, p=0.13) were higher during the first wave. A significant difference between the two waves was the development of bradycardia. In the first wave, 2 (11.7%) patients developed sinus bradycardia only after admission to the intensive care unit, while in the second wave, 63 (98.4%) patients developed sinus bradycardia during hospitalization.ConclusionsSurvival of critically ill patients with COVID-19 was significantly lower during the second wave. The majority of these patients developed sinus bradycardia during hospitalization.


2020 ◽  
Vol 22 (6) ◽  
Author(s):  
Mehmet Suleyman Sabaz ◽  
Sinan Asar ◽  
Zafer Cukurova ◽  
Nagihan Sabaz ◽  
Halil Doğan ◽  
...  

Background: Increasing in emergency department need to critical care, the number of intensive care unit bed worldwide is inadequate to meet these applies. Objectives: The aim of this study was to investigate the effect of waiting for admission to the Intensive Care Unit (ICU) in the Emergency Department (ED) on the length of stay in the ICU and the mortality of critically ill patients. Methods: This retrospective cohort study carried out between January 2012 - 2019 patients admitted to the ICU of a training and research hospital. The data of 1297 adult patients were obtained by searching the Clinical Decision Support System. Results: The data of the patients were evaluated in two groups as those considered to be delayed and non-delayed. It was determined that the delay of two hours increased the risk of mortality 1.5 times. Hazard Ratios (HR) was 1.548 (1.077 - 2.224). Patients whose ICU admission was delayed by 5 - 6 hours were found to have the highest risk in terms of mortality (HR = 2.291 [1.503 - 3.493]). A statistically significant difference was found in the ICU mortality, 28-day and, 90-day mortality between the two groups. ICU mortality for all patients’ general was 25.2% (327/1297). This rate was 11.4% (55/481) in the non-delayed group and 33.3% (272/816) in the delayed group (P < 0.001). The 28-day mortality rate for all patients’ general was 26.9% (349/1297). This rate was found to be 13.5% (65/481) in the non-delayed group and 34.8% (284/816) in the delayed group (P < 0.001). The 90-day mortality for all patients’ general was 28.4% (368/1297). This rate was 14.1% (68/481) in the non-delayed group and 36.8% (300/816) in the delayed group (P < 0.001). Conclusions: Prolonged stay in the ED before admission to the ICU is associated with worse consequences, and increased mortality.


2020 ◽  
Author(s):  
Fahad Marmarchi ◽  
Michael Liu ◽  
Srikant Rangaraju ◽  
Sara C Auld ◽  
Maria Christina Creel-Bulos ◽  
...  

Background: Studies of COVID-19 have shown that African Americans have been affected by the virus at a higher rate compared to other races. This cohort study investigated comorbidities and clinical outcomes by race among COVID-19 patients admitted to the intensive care unit. Methods: This is a case series of critically ill patients admitted with COVID-19 to a tertiary referral teaching hospital in Atlanta, Georgia. The study included all critically ill hospitalized patients between March 6, 2020 and May 5, 2020. Clinical outcomes during hospitalization included mechanical ventilation, renal replacement therapy and mortality stratified by race. Results Of 288 patients included (mean age, 63 +/- 16 years; 45% female), 210 (73%) were African American. African Americans had significantly higher rates of comorbidities compared to other races, including hypertension (80% vs 59%, p=0.001), diabetes (49% vs 34%, p=0.026) and mean BMI (33 kg/m2vs 28 kg/m2, p<0.001). Despite African Americans requiring continuous renal replacement therapy during hospitalization at higher rates than other races (27% vs 13%, p=0.011), rates of intubation, intensive care unit length of stay, and overall mortality (30% vs 24%, p=0.307) were similar. Conclusion This racially diverse series of critically ill COVID-19 patients shows that despite higher rates of comorbidities at hospital admission in African Americans compared with other races, there was no significant difference in mortality.


1995 ◽  
Vol 4 (6) ◽  
pp. 425-428 ◽  
Author(s):  
D Cortese ◽  
L Capp ◽  
S McKinley

BACKGROUND: Patients who are comatose or semicomatose are at risk of corneal dryness and ulceration. OBJECTIVE: To compare and evaluate the effectiveness of two treatments used for the prevention of corneal epithelial breakdown in critically ill patients. METHODS: A randomized clinical trial was used. The sample consisted of critically ill patients (age, 15-84 years) with a limited or absent blink reflex in a 14-bed general intensive care unit in a large metropolitan teaching hospital. Ninety-six eligible patients were studied; of these, 36 were excluded and data from the remaining 60 patients were analyzed. Patients were randomized to receive methylcellulose lubricating drops every 2 hours (n = 30) or to have their eyes covered with a polyethylene film to create a moisture chamber (n = 30). The patients' corneas were tested daily for epithelial breakdown using fluorescein drops. Patients were studied for a minimum of 48 hours and a maximum of 1 week. RESULTS: Eight of the 30 patients in the lubricating drop group had positive fluorescein staining, compared with one in the moisture chamber group. CONCLUSION: Our results suggest that a moisture chamber is more effective than lubricating drops in preventing corneal epithelial breakdown in critically ill patients with limited or absent blink reflex.


QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
A A Abdalalim ◽  
W H Nofal ◽  
R A Abdelrazik ◽  
K M Megahed

Abstract Background Severe infections in critically ill patients and increasing antibiotic resistance are major healthcare problems affecting morbidity and mortality in the intensive care unit. Antibacterial drug discovery and development have slowed considerably in recent years. Aim of the Work Study the outcome of continuous versus intermittent application of meropenem in critically ill patients with septic shock. Patients and Methods This study was carried out on one hundred patients of both sex from those admitted to intensive care unit in Damanhour Medical National Institute.An Informed consent was taken from all patients or their next of kin. Patients were categorized into 2 groups: Group I (Infusion group) patients received a loading dose of 2g of meropenem I.V over 30 minutes followed by continuous infusion of 4g of meropenem over 24 hours. Group II (Bolus group) patients received 2g of meropenem over 30 minutes every 8 hours. Antibiotic therapy stopped at improvement of the clinical state and signs of subsidence of infection (body temperature below 38, 3 °C for more than 24 hours, white blood cells (WBC) count less than 11, 000/mm3 or decrease by 25% of maximal value)minimum time for therapy 5days and maximum time 10 days. Results In the present study there were two groups of critically ill patients with septic shock each of 50 patients. Group one was given meropenem after culture and sensitivity as one gram infusion over 360 minutes every 6 hours. The second group was given meropenem also after culture and sensitivity as two grams bolus over 30 minutes every 8 hours. There were no significant differences between the two groups regarding age and sex distribution. On admission the two groups had high APACHE-II score, but with no significant difference. Also there was no significant difference between the two groups regarding the site of infection nor the infecting organism. As regards WBCs count the mean WBC count was higher in group II than in group I on days 1 and 3 of treatment but there was no statistically significant difference. Conclusion Administration of meropenem on cultured based treatment as 1g/6hrs infusion compared to 2g/8hrs bolus was associated with significant reduction of WBCs count, CRP levels, SOFA score and ICU stay. Improved clinical outcome, reduction in bacterial growth and decreased mortality were better in the infusion group but not significant.


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