The results of a multicenter retrospective controlled clinical study of the efficacy and safety of L-lysine aescinate® in the treatment of traumatic and postoperative cerebral edema

In modern guidelines, the control of intracranial pressure is recognized as an important prerequisite for quality reco-very of brain functions after severe traumatic brain injury (TBI). Among the relatively new approaches to the control of intracranial pressure in severe TBI, a combination drug L-lysine aescinate® is considered. It has endotheliotropic, venotonic, anti-inflammatory, antiplatelet and other effects that allow it to be regarded as a mean for preventing and reducing cerebral edema after TBI. To evaluate the efficacy and effects of L-lysine aescinate®, a multicenter retrospective study was conducted that included 988 patients aged 18 to 65 years with isolated or combined severe or moderate TBI. The median injury severity index was 17 points, i.e. most people had a serious injury. Patients were randomized into two groups, one of which (n = 335) received only standard therapy, while the other (n = 653) — additionally L-lysine aescinate®. L-lysine aescinate® was prescribed on the first day of hospitalization (median — 2.75 hours) and for a course of 2 to 8 days (median — 7 days). Mortality in the intensive care unit (primary endpoint) was 10.3 and 24.2 % in the main and control groups, respectively (difference 13.9 %; 95% confidence interval (CI): 8.93–19.21 %; p < 0.001). Logistic regression method revealed that L-lysine aescinate® was the most important factor influencing patient survival (p < 0.001). Its use increased the chances of survival of a patient with TBI in the intensive care unit by 3.3 times (odds ratio (OR) = 3.311; 95% CI: 2.108–5.200). Similar results were obtained for 30-day hospital mortality. The frequency of recovery of clear consciousness during the hospital stay was 87.0 % in the group of L-lysine aescinate® and 66.0 % in the control group, with a significant difference between them (p < 0.001). Administration of L-lysine aescinate® increased the chances for restoring clear consciousness in a patient with TBI by 3.8 times (OR = 3.823; 95% CI: 2.535–5.765). The results of the study allow us to recommend the inclusion of L-lysine aescinate® in the standard therapy of patients with isolated or combined severe or moderate TBI.

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Behavioral Pain Indicators in Patients with Traumatic Brain Injury Admitted to an Intensive Care Unit

Journal of Caring Sciences ◽

10.15171/jcs.2018.030 ◽

2018 ◽

Vol 7 (4) ◽

pp. 197-203 ◽

Cited By ~ 1

Author(s):

Roghieh Nazari ◽

Saeed Pahlevan Sharif ◽

Kelly A Allen ◽

Hamid Sharif Nia ◽

Bit-Lian Yee ◽

...

Keyword(s):

Intensive Care Unit ◽

Traumatic Brain Injury ◽

Intensive Care ◽

Brain Injury ◽

Injury Severity ◽

Repeated Measure ◽

Neck Stiffness ◽

Significant Difference ◽

Eye Opening ◽

Different Levels

Introduction: A consistent approach to pain assessment for patients admitted to intensive care unit (ICU) is a major difficulty for health practitioners due to some patients’ inability, to express their pain verbally. This study aimed to assess pain behaviors (PBs) in traumatic brain injury (TBI) patients at different levels of consciousness. Methods: This study used a repeated-measure, within-subject design with 35 patients admitted to an ICU. The data were collected through observations of nociceptive and non-nociceptive procedures, which were recorded through a 47-item behavior-rating checklist. The analyses were performed by SPSS ver.13 software. Results: The most frequently observed PBs during nociceptive procedures were facial expression levator contractions (65.7%), sudden eye openings (34.3%), frowning (31.4%), lip changes (31.4%), clear movement of extremities (57.1%), neck stiffness (42.9%), sighing (31.4%), and moaning (31.4%). The number of PBs exhibited by participants during nociceptive procedures was significantly higher than those observed before and 15 minutes after the procedures. Also, the number of exhibited PBs in patients during nociceptive procedures was significantly greater than that of exhibited PBs during the non-nociceptive procedure. The results showed a significant difference between different levels of consciousness and also between the numbers of exhibited PBs in participants with different levels of traumatic brain injury severity. Conclusion: The present study showed that most of the behaviors that have been observed during painful stimulation in patients with traumatic brain injury included facial expressions, sudden eye opening, frowning, lip changes, clear movements of extremities, neck stiffness, and sighing or moaning.

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Abstract TP329: Early Initiation of Oral Antihypertensives Reduces Intensive Care Unit Stay and Hospital Cost in Patients With Hypertensive Intracerebral Hemorrhage

Stroke ◽

10.1161/str.51.suppl_1.tp329 ◽

2020 ◽

Vol 51 (Suppl_1) ◽

Author(s):

Zhu Zhu ◽

Matthew Bower ◽

Sara Stern-Nezer ◽

Steven Atallah ◽

Dana Stradling ◽

...

Keyword(s):

Intensive Care Unit ◽

Intensive Care ◽

Intracerebral Hemorrhage ◽

Resource Utilization ◽

Hospital Cost ◽

Early Initiation ◽

Control Group ◽

Study Group ◽

Significant Difference ◽

Hypertensive Intracerebral Hemorrhage

Background and Purpose: Intravenous nicardipine infusion is effective for intensive blood pressure (BP) control in patients with hypertensive intracerebral hemorrhage (ICH). However, its use requires close hemodynamic monitoring in the intensive care unit (ICU). Prompt transition from nicardipine infusion to oral antihypertensives may reduce ICU length of stay (LOS). This study aimed to examine the effect of early verse late initiation of oral antihypertensives on hospital resource utilization in patients with hypertensive ICH. Methods: This is a retrospective study of patients with hypertensive ICH and initial systolic BP ≥ 180 mmHg from January 1, 2013 to December 31, 2017. Only patients who received nicardipine infusion were included. Based on timing of receiving oral antihypertensives within or after 24 hours of emergency department arrival, patients were divided into study or control group, respectively. Baseline characteristics, duration of nicardipine infusion, ICU and hospital LOS, functional outcome at hospital discharge, and the cost were compared between the 2 groups using univariate and multivariate analysis to adjust for dependent variables. Results: A total of 166 patients (90 in study group, 76 in control group) were identified. There was no significant difference in demographic features, past medical history or initial SBP between the 2 groups. Patients in study group had lower initial NIHSS and ICH scores but higher GCS score than those in the control group. Using multivariant regression analysisto adjust for initial SBP, NIHSS, GCS and ICH scores, early initiation of oral antihypertensives was associated with significant shorter ICU LOS (median 2 vs 5, p =0.004), decreased duration of nicardipine infusion (55.5 ±60.1 vs 121.6 ±141.3, P =0.002), less pharmaceutical cost (median $14207 vs $ 29299, p =0.007) and total hospital cost (median $ 24564 vs $ 47366, p =0.007). After adjustment of confounders, there was also no significant difference in functional independence (mRS 0-2, 42.2% vs 17.1%, p =0.112) or mortality (6.7% vs 13.2%, p = 0.789) between the 2 groups. Conclusions: Early initiation of oral antihypertensive therapy is associated with reduced resource utilization and hospital cost in patients with hypertensive ICH.

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Comparing Neonatal Intensive Care Unit Nursing Support in Mothers With ‎Newborn Abstinence Syndrome (NAS) and Mothers of Healthy Neonates ‎

International Journal of Medical Toxicology and Forensic Medicine ◽

10.32598/ijmtfm.v9i4.26184 ◽

2019 ◽

Vol 9 (4) ◽

Author(s):

Seyedeh Najmeh Hosseini ◽

Arash Ghodousi ◽

Narges Sadeghi ◽

Somayeh Abbasi

Keyword(s):

Intensive Care Unit ◽

Intensive Care ◽

Neonatal Intensive Care Unit ◽

Neonatal Intensive Care ◽

Control Group ◽

Abstinence Syndrome ◽

Nursing Support ◽

Study Results ◽

Significant Difference ◽

The Impact

Background: The experience of having neonates in the Neonatal Intensive Care Unit (NICU) is a psychological crisis. It might cause many emotional problems for parents. Entire parental support is among the duties of the healthcare team. Therefore, this study aimed to compare the nursing support received by the mothers with Newborn Abstinence Syndrome (NAS) and the mothers of other neonates admitted to the NICU. Methods: The present cross-sectional descriptive-analytic study was conducted in the selected hospitals in Kerman Province, Iran. In total, 62 mothers with NAS and 61 non-addicted mothers with neonates admitted to the NICU were selected through convenience sampling method. The inclusion criteria were neonates under the care of parents, neonate admitted to the NICU for at least 24 hours, opiate dependence in the case group mothers, and no substance dependence in the control group mothers. The amount of nursing support for mothers having neonates with NAS was compared with that of the control mothers. The study groups were homogenized in terms of the study variables (neonate age, gender, and the duration of hospitalization). The required data were collected by the Nurse-Parent Support Tool (NPST) and analyzed in SPSS. Results: The study results revealed that among the neonates of 123 mothers, 75(60.97%) were boys, and 58(39.02%) were girls. The majority of neonates in both groups were breastfed. The mean±SD age of the mothers in the case and control group were 31.93±7.25 and 28.99±4.36 years, respectively. The nursing support level was desirable in both groups, and no significant difference was found in this regard (P>0.05). Furthermore, the level of nursing support in emotional, information-communication, self-esteem, and quality caregiving support dimensions was desirable in both groups. Conclusion: The obtained results revealed that nurses’ support was desirable in both groups. The prevalence of maternal addiction and the impact of this social harm on neonates who were admitted are essential. Furthermore, families having neonates with NAS need more support from the healthcare staff and nurses, in comparison with healthy parents; thus, the importance of this issue should be addressed in training and briefing courses for nurses.

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Dialyzable Leukocyte Extract (Transferon™) Administration in Sepsis: Experience from a Single Referral Pediatric Intensive Care Unit

BioMed Research International ◽

10.1155/2019/8980506 ◽

2019 ◽

Vol 2019 ◽

pp. 1-10 ◽

Cited By ~ 4

Author(s):

Maria Isabel Castrejón Vázquez ◽

Aldo Arturo Reséndiz-Albor ◽

Mario A. Ynga-Durand ◽

Ivonne Maciel Arciniega Martínez ◽

Vanessa Ivonne Orellana-Villazon ◽

...

Keyword(s):

Intensive Care Unit ◽

Intensive Care ◽

Pediatric Intensive Care Unit ◽

Laboratory Data ◽

Pediatric Intensive Care ◽

Control Group ◽

Immunomodulatory Agents ◽

Reactive Protein ◽

Significant Difference ◽

Pediatric Sepsis

Immunomodulatory agents have been proposed as therapeutic candidates to improve outcomes in sepsis. Transferon™, a dialyzable leukocyte extract (DLE), has been supported in Mexico as an immunomodulatory adjuvant in anti-infectious therapy. Here we present a retrospective study describing the experience of a referral pediatric intensive care unit (PICU) with Transferon™ in sepsis. We studied clinical and laboratory data from 123 patients with sepsis (15 in the DLE group and 108 in the control group) that were admitted to PICU during the period between January 2010 and December 2016. Transferon™ DLE use was associated with lower C reactive protein (CRP), increase in total lymphocyte counts (TLC), and decrease in total neutrophil count (TNC) 72 hours after Transferon™ DLE administration. The control group did not present any significant difference in CRP values and had lower TLC after 72 hours of admission. There was no difference in PICU length of stay between control and Transferon™ DLE group. Transferon™ DLE administration was associated with a higher survival rate at the end of PICU stay. This study shows a possible immunomodulatory effect of Transferon™ on pediatric sepsis patients.

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Critical Care Management of Cerebral Edema in Brain Tumors

Journal of Intensive Care Medicine ◽

10.1177/0885066615619618 ◽

2016 ◽

Vol 32 (1) ◽

pp. 15-24 ◽

Cited By ~ 18

Author(s):

Yoshua Esquenazi ◽

Victor P. Lo ◽

Kiwon Lee

Keyword(s):

Intensive Care Unit ◽

Critical Care ◽

Intensive Care ◽

Intracranial Pressure ◽

Brain Tumors ◽

Cerebral Edema ◽

Care Management ◽

Neurological Dysfunction ◽

Definitive Treatment ◽

Critical Care Management

Cerebral edema associated with brain tumors is extremely common and can occur in both primary and metastatic tumors. The edema surrounding brain tumors results from leakage of plasma across the vessel wall into the parenchyma secondary to disruption of the blood–brain barrier. The clinical signs of brain tumor edema depend on the location of the tumor as well as the extent of the edema, which often exceeds the mass effect induced by the tumor itself. Uncontrolled cerebral edema may result in increased intracranial pressure and acute herniation syndromes that can result in permanent neurological dysfunction and potentially fatal herniation. Treatment strategies for elevated intracranial pressure consist of general measures, medical interventions, and surgery. Alhough the definitive treatment for the edema may ultimately be surgical resection of the tumor, the impact of the critical care management cannot be underestimated and thus patients must be vigilantly monitored in the intensive care unit. In this review, we discuss the pathology, pathophysiology, and clinical features of patients presenting with cerebral edema. Imaging findings and treatment modalities used in the intensive care unit are also discussed.

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The Effects of Aromatherapy on Intensive Care Unit Patients’ Stress and Sleep Quality: A Nonrandomised Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2017/2856592 ◽

2017 ◽

Vol 2017 ◽

pp. 1-10 ◽

Cited By ~ 8

Author(s):

Eun Hee Cho ◽

Mi-Young Lee ◽

Myung-Haeng Hur

Keyword(s):

Blood Pressure ◽

Intensive Care Unit ◽

Intensive Care ◽

Sleep Quality ◽

Controlled Trial ◽

Experimental Treatment ◽

Stress Index ◽

Control Group ◽

Nursing Interventions ◽

Significant Difference

Background. Stress has both physiological and psychological effects and can negatively impact patients’ treatment and recovery. We examined whether the aromatherapy alleviated patients’ stress and improved their sleep quality and provided data that can be utilized in clinical settings. Methods. This was a nonrandomised controlled experimental study. Participants included lucid adult patients who were admitted to the intensive care unit and had spent more than two nights there. The experimental treatment required participants to engage in deep breathing with essential oils as part of the aromatherapy. The control group was instructed to go to sleep without receiving the lavender aroma oil. Results. The experimental group and control group showed a significant difference in perceived stress (F=60.11, p<.001), objective stress index (F=25.65, p<.001), systolic blood pressure (F=9.09, p<.001), diastolic blood pressure (F=2.47, p=.046), heart rate (F=5.71, p<.001), and sleep quality (F=109.46, p<.001). Conclusions. The results revealed that aromatherapy alleviated stress and improved sleep quality in intensive care unit patients after 2 days of the experimental treatment. These results demonstrate that aromatherapy affects stress and sleep quality, thus indicating its value in nursing interventions. This trial is registered with KCT0002344.

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Identification of Sarcopenia in Elderly Trauma Patients: The Value of Clinical Competency and Experience

The American Surgeon ◽

10.1177/0003134820982854 ◽

2021 ◽

pp. 000313482098285

Author(s):

Daisy M. Proksch ◽

Katherine M. Kelley ◽

Sasha White ◽

Jessica R. Burgess

Keyword(s):

Intensive Care Unit ◽

Intensive Care ◽

Functional Status ◽

Injury Severity ◽

Psoas Muscle ◽

Control Group ◽

Trauma Patients ◽

Medical Providers ◽

Phone Calls ◽

Elderly Trauma Patients

Introduction There is currently no standard definition of sarcopenia, which has often been associated with frailty. A commonly cited surrogate measure of sarcopenia is psoas muscle size. The purpose of this prospective study is to assess medical providers’ capabilities to identify frail elderly trauma patients and consequent impact on outcomes after intensive care unit admission. Methods Trauma intensive care unit patients over the age of 50 were enrolled. A preadmission functional status questionnaire was completed on admission. Attendings, residents, and nurses, blinded to their patient’s sarcopenic status, completed surveys regarding 6-month prognosis. Chart review included cross-sectional psoas area measurements on computerized tomography scan. Finally, patients received phone calls 3 and 6 months after admission to determine overall health and functional status. Results Seventy-six participants had an average age of 70 years and a corrected psoas area of 383 ± 101 mm2/m2. Injury Severity Score distribution (17.2 ± 8.9) was similar for both groups. Patients also had similar preinjury activities of daily living. Both groups had similar hospital courses. While sarcopenic patients were less likely to be predicted to survive to 6 months (60% vs. 76%, P = 0.017), their actual 6-month mortality was similar (22% vs. 21%, P = 0.915). Conclusion Despite similar objective measures of preadmission health and trauma injury severity, medical providers were able to recognize frail patients and predicted they would have worse outcomes. Interestingly, sarcopenic patients had similar outcomes to the control group. Additional studies are needed to further delineate factors influencing provider insight into functional reserves of elderly trauma patients.

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Infliximab and Intravenous Gammaglobulin in Hospitalized Severe COVID-19 Patients in Intensive Care Unit

Archives of Iranian Medicine ◽

10.34172/aim.2021.22 ◽

2021 ◽

Vol 24 (2) ◽

pp. 139-143

Author(s):

Mohsen Farrokhpour ◽

Nader Rezaie ◽

Najmeh Moradi ◽

Fatemeh Ghaffari Rad ◽

Shirin Izadi ◽

...

Keyword(s):

Intensive Care Unit ◽

Intensive Care ◽

Combination Therapy ◽

Clinical Symptoms ◽

Observational Research ◽

Control Group ◽

Therapeutic Effects ◽

Significant Difference ◽

Intravenous Gammaglobulin ◽

Underlying Diseases

Background: Severe coronavirus disease 2019 (COVID-19) may lead to the cytokine storm syndrome which may cause acute respiratory failure syndrome and death. Our aim was to investigate the therapeutic effects of infliximab, intravenous gammaglobulin (IVIg) or combination therapy in patients with severe COVID-19 disease admitted to the intensive care unit (ICU). Methods: In this observational research, we studied 104 intubated adult patients with severe COVID-19 infection (based on clinical symptoms, and radiographic or CT scan parameters) who were admitted to the ICU of a multispecialty hospital during March 2020 in Tehran, Iran. All cases received standard treatment regimens as local protocol (Oseltamivir + hydroxychloroquine + lopinavir/ritonavir or sofosbuvir or atazanavir ± ribavirin). The cases were grouped as controls (n = 43), infliximab (n = 27), IVIg (n = 23) and combination (n = 11). Results: There was no significant difference between controls and treatment groups in terms of underlying diseases or the number of underlying diseases. The mean age (SD) of cases was 72.42 (16.06) in the control group, 64.52 (12.965) in IVIg, 63.40 (17.57) in infliximab and 64.00 (11.679) in combination therapy; (P = 0.047, 0.031 and 0.11, respectively). Also, 37% in the infliximab group, 26.1% in IVIg, 45.5% in combination therapy, and 62.8% in the control group expired (all P < 0.05). Hazard ratios were 0.31 in IVIg (95% CI: 0.12-0.76, P = 0.01), 0.30 in infliximab (95% CI: 0.13-0.67, P = 0.004), 0.39 in combination therapy (95% CI: 0.12-1.09, P = 0.071). Conclusion: According to the findings of this study, it seems that infliximab and IVIg, alone or together, in patients with severe COVID-19 disease can be considered an effective treatment.

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Procalcitonin-guided antibiotic therapy for suspected and confirmed sepsis of patients in a surgical-trauma ICU: a prospective, two-period cross-over, interventional study

10.21203/rs.2.15320/v1 ◽

2019 ◽

Author(s):

Rispah Chomba ◽

Maeyane Steve Moeng ◽

Warren Lowman

Keyword(s):

Intensive Care Unit ◽

Intensive Care ◽

Hospital Mortality ◽

Antibiotic Treatment ◽

Intervention Group ◽

Control Group ◽

Surgical Trauma ◽

Trauma Patients ◽

Significant Difference ◽

Antibiotic Duration

Abstract Background: Biomarkers like procalcitonin (PCT) are an important antimicrobial stewardship tool for critically ill patients. The purpose of our study was to compare a procalcitonin guided antibiotic algorithm to standard antibiotic treatment in surgical trauma patients admitted to the intensive care unit (ICU).Methods: A prospective, two period cross-over study was conducted in a surgical trauma intensive care unit in South Africa. In the first period, 40 patients were recruited into the control group and antibiotics were discontinued as per standard of care. In the second period, 40 patients were recruited into the procalcitonin group and antibiotics were discontinued if the PCT decreased by ≥ 80% from the peak PCT level, or to an absolute value of less than 0.5 µg/L. Antibiotic duration of treatment was the primary outcome. Patients were followed up for 28 days from the first sepsis event.Results: For the first sepsis event the PCT group had a mean antibiotic duration of 9.3 days while the control group had a mean duration of 10.9 days (p=0.10). Patients in the intervention group had more antibiotic free days alive (mean 7.7±6.57 days) compared to the control group ﴾mean 3.8±5.22 days, (p=0.004﴿. The length of ICU stay and length of hospital stay for the two groups were similar. The in-hospital mortality was reduced in the intervention group (15%) compared to the control group (30%).Conclusion: There was no significant difference in duration of antibiotic treatment between the two groups. However, the PCT group had more antibiotic free days alive and lower in-hospital mortality compared to the control group.Trial registration: Pan African clinical trial registry, PACTR201909715467725, date of registration: 20.9.2019; retrospectively registered, https://pactr.samrc.ac.za/Search.aspx

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Clinical Study on the Efficacy and Safety of Arginine Administered Orally in Association with Other Active Ingredients for the Prevention and Treatment of Sarcopenia in Patients with COVID-19-Related Pneumonia, Hospitalized in a Sub-Intensive Care Unit

Healthcare ◽

10.3390/healthcare10010162 ◽

2022 ◽

Vol 10 (1) ◽

pp. 162

Author(s):

Carolina Bologna ◽

Eduardo Pone

Keyword(s):

Intensive Care Unit ◽

Intensive Care ◽

Standard Therapy ◽

Vastus Lateralis ◽

Statistical Significance ◽

Randomized Study ◽

Control Group ◽

Average Value ◽

Prevention And Treatment ◽

Handgrip Test

In order to evaluate the efficacy of oral supplementation with 3 g of arginine per day associated with creatine, L-carnitine, aspartic acid, magnesium, selenium and vitamins C and E (Argivit© Aesculapius Farmaceutici) in the prevention and treatment of sarcopenia in patients with COVID-19-related pneumonia, we conducted a parallel randomized study comparing it with standard therapy alone. Forty patients on standard therapy plus supplementation were compared with a control group of 40 patients, all hospitalized at the sub-intensive care unit of the Del Mare Hospital in Naples, with a clinical diagnosis of SARS-CoV-2 infection and COVID-19 pneumonia. Muscle strength was assessed with the handgrip test and muscle ultrasound. Arginine-supplemented patients had an average grip strength of 23.5 at the end of hospitalization compared with 22.5 in the untreated group with less reduction, showing statistical significance (p < 0.001). In the same way, the thickness of the vastus lateralis quadriceps femoris muscle measured at the end of hospitalization showed less reduction on ultrasound, with a higher average value in the group receiving treatment than in the group of patients without supplementation (p < 0.001). Upon discharge there was a 58.40% reduction in ventilation days in patients with arginine supplementation compared with the control group.

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