scholarly journals The Effect of Early Treatment with Intravenous Magnesium Sulfate on the Incidence of Cardiac Comorbidities in Hospitalized Stroke Patients

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Kameron Bechler ◽  
Kristina Shkirkova ◽  
Jeffrey L. Saver ◽  
Sidney Starkman ◽  
Scott Hamilton ◽  
...  
Keyword(s):  
Adverse Events ◽  
Acute Stroke ◽  
Magnesium Sulfate ◽  
Serum Magnesium ◽  
High Dose ◽  
Stroke Patients ◽  
Serious Adverse Events ◽  
Intravenous Magnesium ◽  
Prophylactic Measures ◽  
Cardiac Adverse Events

Background. Cardiac adverse events are common among patients presenting with acute stroke and contribute to overall morbidity and mortality. Prophylactic measures for the reduction of cardiac adverse events in hospitalized stroke patients have not been well understood. We sought to investigate the effect of early initiation of high-dose intravenous magnesium sulfate on cardiac adverse events in stroke patients. Methods. This is a secondary analysis of the prehospital Field Administration of Stroke Therapy-Magnesium (FAST-MAG) randomized phase-3 clinical trial, conducted from 2005-2013. Consecutive patients with suspected acute stroke and a serum magnesium level within 72 hours of enrollment were selected. Twenty grams of magnesium sulfate or placebo was administered in the ambulance starting with a 15-minute loading dose intravenous infusion followed by a 24-hour maintenance infusion in the hospital. Results. Among 1126 patients included in the analysis of this study, 809 (71.8%) patients had ischemic stroke, 277 (24.6%) had hemorrhagic stroke, and 39 (3.5%) with stroke mimics. The mean age was 69.5 (SD13.4) and 42% were female. 565 (50.2%) received magnesium treatment, and 561 (49.8%) received placebo. 254 (22.6%) patients achieved the target, and 872 (77.4%) did not achieve the target, regardless of their treatment group. Among 1126 patients, 159 (14.1%) had at least one CAE. Treatment with magnesium was not associated with fewer cardiac adverse events. A multivariate binary logistic regression for predictors of CAEs showed a positive association of older age and frequency of CAEs (R=1.04, 95% CI 1.03-1.06, p<0.0001). Measures of early and 90-day outcomes did not differ significantly between the magnesium and placebo groups among patients who had CAEs. Conclusion. Treatment of acute stroke patients with magnesium did not result in a reduction in the number or severity of cardiac serious adverse events.

Embedding an enriched environment in an acute stroke unit increases activity in people with stroke: a controlled before–after pilot study

2017 ◽  
Vol 31 (11) ◽  
pp. 1516-1528 ◽  
Author(s):  
Ingrid CM Rosbergen ◽  
Rohan S Grimley ◽  
Kathryn S Hayward ◽  
Katrina C Walker ◽  
Donna Rowley ◽  
...  
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Acute Stroke ◽  
Usual Care ◽  
Stroke Unit ◽  
Enriched Environment ◽  
Activity Levels ◽  
Stroke Patients ◽  
Serious Adverse Events ◽  
Acute Stroke Unit

Objectives: To determine whether an enriched environment embedded in an acute stroke unit could increase activity levels in acute stroke patients and reduce adverse events. Design: Controlled before–after pilot study. Setting: An acute stroke unit in a regional Australian hospital. Participants: Acute stroke patients admitted during (a) initial usual care control period, (b) an enriched environment period and (c) a sustainability period. Intervention: Usual care participants received usual one-on-one allied health intervention and nursing care. The enriched environment participants were provided stimulating resources, communal areas for eating and socializing and daily group activities. Change management strategies were used to implement an enriched environment within existing staffing levels. Main Measures: Behavioural mapping was used to estimate patient activity levels across groups. Participants were observed every 10 minutes between 7.30 am and 7.30 pm within the first 10 days after stroke. Adverse and serious adverse events were recorded using a clinical registry. Results: The enriched environment group ( n = 30, mean age 76.7 ± 12.1) spent a significantly higher proportion of their day engaged in ‘any’ activity (71% vs. 58%, P = 0.005) compared to the usual care group ( n = 30, mean age 76.0 ± 12.8). They were more active in physical (33% vs. 22%, P < 0.001), social (40% vs. 29%, P = 0.007) and cognitive domains (59% vs. 45%, P = 0.002) and changes were sustained six months post implementation. The enriched group experienced significantly fewer adverse events (0.4 ± 0.7 vs.1.3 ± 1.6, P = 0.001), with no differences found in serious adverse events (0.5 ± 1.6 vs.1.0 ± 2.0, P = 0.309). Conclusions: Embedding an enriched environment in an acute stroke unit increased activity in stroke patients.

Abstract TMP12: Does Prehospital Magnesium Sulfate Differentially Improve Outcome in Hyperacute Stroke Patients With Higher Pretreatment Blood Pressure?

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Phoebe H Johnson-Black ◽  
Sidney Starkman ◽  
Nerses Sanossian ◽  
David Liebeskind ◽  
Samuel Stratton ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Cerebrovascular Disease ◽  
Acute Stroke ◽  
Magnesium Sulfate ◽  
Controlled Trial ◽  
Functional Independence ◽  
Forest Plot ◽  
Stroke Patients ◽  
Improve Outcome ◽  
Acute Cerebral Ischemia

Introduction: Magnesium sulfate (Mg) has blood pressure (BP) lowering, cerebral blood flow enhancing, and neuroprotective effects in preclinical and clinical studies. In the IMAGES phase 3 trial, Mg up to 12h after onset showed no benefit in acute stroke, but was associated with improved outcome in patients with higher blood pressure at entry. Hypothesis: We tested the hypothesis that ultra-early Mg improves functional outcome in acute stroke patients with higher baseline BP. Methods: FAST-MAG is a multicenter, double-blind, randomized, placebo-controlled trial of paramedic-initiated Mg, administered to patients with suspected stroke within 2h of symptom onset. The primary analysis showed neutral effect of Mg. This secondary analysis examines rates of functional independence (mRS 0-2) at 3m for Mg and placebo for different field BP groups. Results: Among 1622 patients with acute cerebrovascular disease, age was 69.6 (±13.4), 42% female, entry deficit severity in the field was LAMS 3.8 (±1.2), and first post-enrollment NIHSS in the ED was 11.5 (±9.9). Systolic blood pressure prior to enrollment was higher among patients with intracerebral hemorrhage (ICH) than acute cerebral ischemia (ACI), 175 (±25) vs 155 (±27), p < .001. The Figure shows the Forest plot for Mg vs placebo and functional independence among blood pressure groups. Heterogeneity of treatment effect was noted in the all-cerebrovascular patients population (p < .01), with fewer independent outcomes with Mg than placebo among patients with higher entry BPs. Analysis of Functional Independence (mRS 0-2) at 90 Days in Prespecified Subgroups Conclusion: This analysis did not confirm the prior finding of magnesium sulfate benefit among acute stroke patients with elevated blood pressure (and actually provided a signal in the opposing direction). Mg was not demonstrated to improve outcome when started in the first 2h of onset among patients with acute cerebrovascular disease and higher blood pressures.

scholarly journals Open-Label Clinical Trials of Oral Pulse Dexamethasone for Adults with Idiopathic Nephrotic Syndrome

2019 ◽  
Vol 49 (5) ◽  
pp. 377-385 ◽  
Author(s):  
Monique E. Cho ◽  
Mary H. Branton ◽  
David A. Smith ◽  
Linda Bartlett ◽  
Lilian Howard ◽  
...  
Keyword(s):  
Nephrotic Syndrome ◽  
Adverse Events ◽  
Idiopathic Nephrotic Syndrome ◽  
High Dose ◽  
Open Label ◽  
Serious Adverse Events ◽  
Oral Dexamethasone ◽  
Dose Oral ◽  
Pulse Dexamethasone ◽  
Daily Prednisone

Background: In adults with primary focal segmental glomerulosclerosis (FSGS), daily prednisone may induce complete remissions (CR) and partial remissions (PR), but relapses are frequent and adverse events are common. Methods: We carried out 2 open-label, uncontrolled trials to explore the efficacy and tolerability of pulse oral dexamethasone as an alternative to daily prednisone. We enrolled adult patients with proteinuria > 3.5 g/day despite the use of renin-angiotensin-aldosterone blockade. In the first trial, we enrolled 14 subjects with FSGS and administered 4 dexamethasone doses (25 mg/m2) daily for 4 days, repeated every 28 days over 32 weeks. The second trial involved a more intensive regimen. Eight subjects received 4 dexamethasone doses of 50 mg/m2 every 4 weeks for 12 weeks, followed by 4 doses of 25 mg/m2 every 4 weeks for 36 weeks; subjects were randomized to 2 doses every 2 weeks or 4 doses every 4 weeks. Results: In the first trial, we enrolled 13 subjects with FSGS and 1 with minimal change disease and found a combined CR and PR rate of 36%. In the second trial, we enrolled 8 subjects. The combined CR and PR rate was 29%. Analysis combining both trials showed a combined CR and PR rate of 33%. Adverse events were observed in 32% of subjects, with mood symptoms being most common. There were no serious adverse events related to the study. Conclusion: We conclude that high dose oral dexamethasone is well tolerated by adults with idiopathic nephrotic syndrome and may have some efficacy.

Failure of High-Dose Intravenous Magnesium Sulfate to Control Myoclonic Status Epilepticus

1988 ◽  
Vol 11 (6) ◽  
pp. 537-544 ◽  
Author(s):  
Robert S. Fisher ◽  
Peter W. Kaplan ◽  
Allan Krumholz ◽  
Ronald P. Lesser ◽  
Steven A. Rosen ◽  
...  
Keyword(s):  
Status Epilepticus ◽  
Magnesium Sulfate ◽  
High Dose ◽  
Intravenous Magnesium

Magnesium Sulfate Does Not Reduce Postoperative Analgesic Requirements

2001 ◽  
Vol 95 (3) ◽  
pp. 640-646 ◽  
Author(s):  
Seong-Hoon Ko ◽  
Hye-Rin Lim ◽  
Dong-Chan Kim ◽  
Young-Jin Han ◽  
Huhn Choe ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Magnesium Sulfate ◽  
Serum Magnesium ◽  
Magnesium Concentration ◽  
Saline Control ◽  
Control Group ◽  
Forced Expiration ◽  
Inverse Relation ◽  
Analgesic Consumption ◽  
Intravenous Magnesium

Background Because magnesium blocks the N-methyl-D-aspartate receptor and its associated ion channels, it can prevent central sensitization caused by peripheral nociceptive stimulation. However, transport of magnesium from blood to cerebrospinal fluid (CSF) across the blood-brain barrier is limited in normal humans. The current study was designed to evaluate whether perioperative intravenous magnesium sulfate infusion affects postoperative pain. Methods Sixty patients undergoing abdominal hysterectomy received 50 mg/kg intravenous magnesium sulfate as a bolus dose followed by a continuous infusion of 15 mg x kg(-1) x h(-1) for 6 h (magnesium group) or the same volume of isotonic saline (control group). At the end of surgery, serum and CSF magnesium concentration were measured in both groups. The cumulative postoperative analgesic consumption was measured to assess the analgesic effect using a patient-controlled epidural analgesia device. Pain intensities at rest and during forced expiration were evaluated at 6, 24, 48, and 72 h postoperatively. Results At the end of surgery, patients in the magnesium group had significantly greater postoperative serum magnesium concentrations compared with both preoperative and control group values (P &lt; 0.001). Despite significantly higher serum magnesium concentrations in the magnesium group, there was no significant difference in magnesium concentration measured in postoperative CSF. Cumulative postoperative analgesic doses were similar in both groups. However, there was observed an inverse relation between cumulative postoperative analgesic consumption and the CSF magnesium concentration in both groups. Visual analog pain scores at rest and during forced expiration were similar and less than 4 in both groups. Conclusions Perioperative intravenous administration of magnesium sulfate did not increase CSF magnesium concentration and had no effects on postoperative pain. However, an inverse relation between cumulative postoperative analgesic consumption and the CSF magnesium concentration was observed. These results suggest that perioperative intravenous magnesium infusion may not be useful for preventing postoperative pain.

Phase 1 Safety and Immunogenicity Study of a Respiratory Syncytial Virus Vaccine With an Adenovirus 26 Vector Encoding Prefusion F (Ad26.RSV.preF) in Adults Aged ≥60 Years

2020 ◽  
Vol 222 (6) ◽  
pp. 979-988 ◽  
Author(s):  
Kristi Williams ◽  
Arangassery Rosemary Bastian ◽  
Robert Allen Feldman ◽  
Edmund Omoruyi ◽  
Els de Paepe ◽  
...  
Keyword(s):  
Older Adults ◽  
Respiratory Syncytial Virus ◽  
Adverse Events ◽  
Immune Responses ◽  
Phase 1 ◽  
Geometric Mean ◽  
High Dose ◽  
Serious Adverse Events ◽  
Syncytial Virus ◽  
Vector Particles

Abstract Background Despite the high disease burden of respiratory syncytial virus (RSV) in older adults, there is no approved vaccine. We evaluated the experimental RSV vaccine, Ad26.RSV.preF, a replication-incompetent adenovirus 26 vector encoding the F protein stabilized in prefusion conformation. Methods This phase 1 clinical trial was performed in healthy adults aged ≥60 years. Seventy-two participants received 1 or 2 intramuscular injections of low-dose (LD; 5 × 1010 vector particles) or high-dose (HD; 1 × 1011 vector particles) Ad26.RSV.preF vaccine or placebo, with approximately 12 months between doses and 2-year follow-up for safety and immunogenicity outcomes. Results Solicited adverse events were reported by 44% of vaccine recipients and were transient and mild or moderate in intensity. No serious adverse events were related to vaccination. After the first vaccination, geometric mean titers for RSV-A2 neutralization increased from baseline (432 for LD and 512 for HD vaccine) to day 29 (1031 for LD and 1617 for HD). Pre-F–specific antibody geometric mean titers and median frequencies of F-specific interferon γ–secreting T cells also increased substantially from baseline. These immune responses were still maintained above baseline levels 2 years after immunization and could be boosted with a second immunization at 1 year. Conclusions Ad26.RSV.preF (LD and HD) had an acceptable safety profile and elicited sustained humoral and cellular immune responses after a single immunization in older adults.

Efficacy and safety of pharmacological cachexia interventions: systematic review and network meta-analysis

2020 ◽  
pp. bmjspcare-2020-002601
Author(s):  
Manit Saeteaw ◽  
Phitjira Sanguanboonyaphong ◽  
Jukapun Yoodee ◽  
Kaitlyn Craft ◽  
Ratree Sawangjit ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Meta Analysis ◽  
Total Body Weight ◽  
Megestrol Acetate ◽  
High Dose ◽  
Efficacy And Safety ◽  
Pharmacological Interventions ◽  
Serious Adverse Events ◽  
Significant Difference

AimsRandomised controlled trials (RCTs) demonstrated benefits of pharmacological interventions for cachexia in improving weight and appetite. However, comparative efficacy and safety are not available. We conducted a systematic review and network meta-analysis (NMA) to evaluate the relative efficacy and safety of pharmacological interventions for cachexia.MethodsPubMed, EmBase, Cochrane, and ClinicalTrials.gov were searched for RCTs until October 2019. Key outcomes were total body weight (TBW) improvement, appetite (APP) score and serious adverse events. Two reviewers independently extracted data and assessed risk of bias. NMA was performed to estimate weight gain and APP score increase at 8 weeks, presented as mean difference (MD) or standardised MD with 95% CI.Results80 RCTs (10 579 patients) with 12 treatments were included. Majority is patients with cancer (7220). Compared with placebo, corticosteroids, high-dose megestrol acetate combination (Megace_H_Com) (≥400 mg/day), medroxyprogesterone, high-dose megestrol acetate (Megace_H) (≥400 mg/day), ghrelin mimetic and androgen analogues (Androgen) were significantly associated with MD of TBW of 6.45 (95% CI 2.45 to 10.45), 4.29 (95% CI 2.23 to 6.35), 3.18 (95% CI 0.94 to 5.41), 2.66 (95% CI 1.47 to 3.85), 1.73 (95% CI 0.27 to 3.20) and 1.50 (95% CI 0.56 to 2.44) kg. For appetite improvement, Megace_H_Com, Megace_H and Androgen significantly improved standardised APP score, compared with placebo. There is no significant difference in serious adverse events from all interventions compared with placebo.ConclusionsOur findings suggest that several pharmacological interventions have potential to offer benefits in treatment of cachexia especially Megace_H and short-term use corticosteroids. Nonetheless, high-quality comparative studies to compare safety and efficacy are warranted for better management of cachexia.

Management Of Immunotherapy Adverse Events In Oncological Patients: Anti-Ctla-4, Anti-Pd-1/Pd-L1

2020 ◽  
Vol 15 ◽  
Author(s):  
Mattia Brigida ◽  
Alessia Perricelli ◽  
Fausto Sposato ◽  
Maria Giovanna Spadafora ◽  
Angelo Pomillo ◽  
...  
Keyword(s):  
Adverse Events ◽  
Checkpoint Inhibitors ◽  
Standard Of Care ◽  
Corticosteroid Treatment ◽  
High Dose ◽  
Emergency Setting ◽  
Serious Adverse Events ◽  
Oncological Patients ◽  
Grade Ii ◽  
Dose Corticosteroid

Background: The widespread use of immunotherapy drugs in the oncological field has led to the spread of new toxicities compared to the more common chemotherapy treatments. This is because immunotherapy with anti-CTLA-4 (Cytotoxic T Lymphocytes-Associated Antigen 4), anti-PD-1 and anti-PD-L1 monoclonal antibodies has become the standard-of-care in a growing number of indications. Any organ or tissue can be involved, but more commonly side effects are reported regarding skin, colon, endocrine glands, liver, lung and kidney. Other less frequent, but more serious, adverse events are neurological and myocarditis. Methods: We performed an electronic search on PUBMED of the literature concerning immunotherapy-related toxicities and their management in oncological patients from 2007 to 2020, with particular attention to the most recent publications. Aim: To summarize the different types of immunotherapy-related toxicities, together with their incidence and diagnosis, and to simplify their management, especially in the emergency setting. Conclusion: Usually, for grade I toxicities it is not recommended to stop immunotherapy; for most of grade II toxicities, immunotherapy should be postponed to when toxicity will have regressed to grade I, considering the possibility of a corticosteroid treatment for most of toxicities. The majority of grade III and IV require administration of high-dose corticosteroid intravenous therapy and suspension of immunotherapy. Mortality related to immune checkpoint inhibitors’ toxicity, occurring at a rate of 0.3-1.3%, is well below fatality rates due to other oncologic interventions and should not discourage the promising results so far reached by immunotherapy.

Outpatient administration of high-dose methotrexate for osteosarcoma treatment in Brazil

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 10038-10038 ◽  
Author(s):  
C. R. Macedo ◽  
A. M. Cappellano ◽  
D. T. Noguchi ◽  
A. P. Martinho ◽  
C. G. Dias ◽  
...  
Keyword(s):  
Adverse Events ◽  
Patient Adherence ◽  
Elevated Serum ◽  
Serum Levels ◽  
High Dose ◽  
High Dose Methotrexate ◽  
Serious Adverse Events ◽  
Early Introduction ◽  
Dose Methotrexate ◽  
Metronomic Treatment

10038 Background: We describe the experience with outpatient administration of high dose methotrexate (HDMTX) and leucovorin rescue for osteosarcoma treatment at Instituto de Oncologia Pediátrica. Methods: HDMTX (12g/m2) is administered as part of the Brazilian Osteosarcoma Treatment Group Protocol in an ambulatory basis. Daily MTX serum levels and fluid controls follows until the serum level is <0,2 μ/L. Families were oriented to measure urinary pH and volume, PO intake and to adjust leucovorin dose as needed. To achieve treatment adherence, a family education program was developed. Concomitantly to HD chemotherapy, low dose oral cyclophosphamide and MTX (metronomic treatment) were provided to metastatic (M) patients. This is a retrospective analysis of the HDMTX courses administered between 2006 and 2008. Results: Out of 341 HDMTX infusions, administered to 42 patients, 42.5% had abnormal serum levels at hour 24, 8.8% at hour 48 and 33.2% at hour 72. After required interventions, 2.9% (n = 8) had serum levels >0.2 μ/L at hour 72 leading to delayed excretion. Of these, 7 had also creatinine elevation and main adverse events were mucositis, reversible transaminasis elevation and one sepsis. In the overall analysis, other toxicities included mucositis grade II (20%), nefrotoxicity (5.6%) and neutropenia grades III and IV (25.4%). Serious adverse events of seizure, allergic reaction, and Steven Johnson's Syndrome lead to suspension of future HDMTX administration in 4 patients (01 metastatic). The main differences found between M and non-M patients were 16.8% versus 8.7% of leucopenia grade IV and 12.1% versus 6.6% of anemia grades III and IV. Conclusions: Similar to other authors’ experience, outpatient administration of HDMTX lead to elevated serum levels in 42.5% of the infusions, demonstrating the importance of a well trained staff and early introduction of supportive therapies to avoid associated toxicities. To a developing country, this approach helps lowering treatment costs and infection risks and increases patient adherence to treatment, with acceptable toxicities, even with the introduction of metronomic treatment. No significant financial relationships to disclose.

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