Clonidine as an adjuvant in the management of acute poisoning by anticholinesterase pesticides

2015 ◽  
Vol 35 (4) ◽  
pp. 371-376 ◽  
Author(s):  
AA El-Ebiary ◽  
SA Gad ◽  
AA Wahdan ◽  
IH El-Mehallawi
Keyword(s):  
Clinical Outcomes ◽  
Length Of Hospital Stay ◽  
Acute Poisoning ◽  
Assisted Ventilation ◽  
Serum Cholinesterase ◽  
Pesticide Poisoning ◽  
Open Label ◽  
Routine Treatment ◽  
Group I ◽  
Open Label Phase

Introduction: Anticholinesterase pesticides are widely used in agriculture and domestic settings throughout the world, and they are responsible for great morbidity and mortality. In Egypt and other developing countries, there is a pressing need for new affordable antidotes to treat anticholinesterase pesticide poisoning. Hence, this study was conducted to evaluate the safety and effectiveness of moderate doses of clonidine in the management of adult patients with acute anticholinesterase pesticide poisoning. Methodology: This study was an open-label, phase II pilot clinical trial. Sixty patients with acute anticholinesterase pesticide poisoning gave consent to participate in the study. They were divided into 2 equal groups, with 30 patients in each group. Group I received clonidine plus the routine treatment, while group II received only the routine treatment. Patients were subjected to full history taking, and their vital and clinical data were recorded. Serum cholinesterase levels and routine laboratory investigations were measured. The different outcomes of the patients were assessed. Results: The baseline characteristics of both groups were similar. Thirteen (43.3%) patients developed significant hypotension during clonidine treatment. The clinical outcomes (including mortality, need for assisted ventilation, length of hospital stay, and total doses of atropine) showed no significant differences between the two groups. Conclusion: The use of clonidine in acute anticholinesterase pesticide poisoning may be associated with a high incidence of hypotension requiring intervention. The clinical outcomes may not significantly improve in clonidine-treated patients.

scholarly journals Clinical characteristics and treatment of mixed-pesticide poisoning in a patient: reflections on a particular case

2020 ◽  
Vol 48 (12) ◽  
pp. 030006052097739
Author(s):  
Yiming Tao ◽  
Tingting Liu ◽  
Jie Han ◽  
Xiangdong Jian ◽  
Baotian Kan
Keyword(s):  
Medical History ◽  
Intramuscular Injection ◽  
Clinical Symptoms ◽  
Delayed Diagnosis ◽  
Acute Poisoning ◽  
Assisted Ventilation ◽  
Pesticide Poisoning ◽  
Methods Of Suicide ◽  
Commit Suicide ◽  
Careful Physical Examination

Patients who commit suicide often deliberately hide their medical history. Given that taking pesticides is one of the most common methods of suicide, other forms of poisoning may be neglected in clinical practice. We report here a case of mixed-pesticide poisoning. The patient was poisoned by oral administration of a coumarin rodenticide in combination with an intramuscular injection of organophosphorus (OP) pesticide. The patient was treated with vitamin K1, cholinesterase reactivators, atropine, ventilator-assisted ventilation, and bedside debridement. Her condition gradually stabilized and she eventually recovered and was discharged. Assessment of the causes of delayed diagnosis and treatment suggests that we need to improve early detection and treatment of acute poisoning. It is especially important to ask about the patient’s medical history, conduct a careful physical examination, and track the clinical symptoms and differential diagnosis of common poisoning. In addition to the three common routes of poisoning—oral, inhalation, and cutaneous mucosal contact—intramuscular injection of OP can also lead to severe poisoning, which manifests as respiratory failure.

Association of tumor mutational burden (TMB) and clinical outcomes with pembrolizumab (pembro) versus chemotherapy (chemo) in patients with metastatic triple-negative breast cancer (mTNBC) from KEYNOTE-119.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 1013-1013 ◽  
Author(s):  
Eric P. Winer ◽  
Oleg Lipatov ◽  
Seock-Ah Im ◽  
Anthony Goncalves ◽  
Eva Muñoz-Couselo ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Cox Regression ◽  
Single Agent ◽  
Positive Association ◽  
Open Label ◽  
P Values ◽  
Systemic Treatments ◽  
Number Of Patients ◽  
Open Label Phase ◽  
Tumor Mutational Burden

1013 Background: In the randomized, open-label, phase 3 KEYNOTE-119 study (NCT02555657) , OS was not significantly different with pembro monotherapy versus chemo in second- or third-line settings for mTNBC; however, the pembro treatment effect increased with increasing PD-L1 enrichment. We evaluated the association of TMB with efficacy of pembro monotherapy versus chemo in patients with previously treated mTNBC. Methods: Patients with centrally confirmed TNBC and 1 or 2 prior systemic treatments for metastatic disease were enrolled. Patients were randomly assigned 1:1 to pembro 200 mg Q3W or single-agent chemo per investigator’s choice of capecitabine, eribulin, gemcitabine, or vinorelbine. Association of TMB, as measured by FoundationOne CDx (Foundation Medicine), with response was an exploratory objective evaluated using receiver operator characteristic (ROC) analysis, logistic regression (ORR), and Cox regression (OS; PFS) within treatment arms; estimates of efficacy based on TMB cutpoint used a prespecified cutpoint of 10 mut/Mb. Results: TMB data were available for 253/601 (42.1%) treated patients (pembro, n = 132; chemo, n = 121); baseline characteristics were similar to that of the overall study population. One-sided P values for the association of TMB and clinical outcomes in pembro-treated patients were 0.154 for ORR, 0.014 for PFS, and 0.018 for OS; the area under the ROC curve ([AUROC] 95% CI) for predicting ORR was 0.58 (0.43-0.73). Two-sided P values for the association of TMB and clinical outcomes in chemo-treated patients were 0.114 for ORR, 0.478 for PFS, and 0.906 for OS; AUROC (95% CI) was 0.43 (0.27-0.59). Twenty-six patients had TMB ≥10 mut/Mb. Thus, the prevalence of TMB ≥10 mut/Mb was ~10%. Outcomes based on TMB cutpoint are reported in the Table. Conclusions: Data from this exploratory analysis from KEYNOTE-119 suggest a potential positive association between TMB and clinical benefit with pembro but not chemo in patients with mTNBC. Although precision is limited by sample size and the number of patients with TMB ≥10 mut/Mb, ORR and HRs for OS suggested a trend towards increased benefit with pembro versus chemo in patients with TMB ≥10 mut/Mb. Clinical trial information: NCT02555657 . [Table: see text]

scholarly journals Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open label, phase III study (NUTRILEAK study)

2019 ◽  
Author(s):  
Caroline Gronnier ◽  
Cécile Chambrier ◽  
Alain Duhamel ◽  
Benoît Dervaux ◽  
Denis Collet ◽  
...  
Keyword(s):  
Hospital Stay ◽  
Length Of Hospital Stay ◽  
Phase Iii ◽  
Fistula Closure ◽  
Related Complication ◽  
Open Label ◽  
Closure Rate ◽  
Open Label Phase ◽  
Related Quality ◽  
Health Related

Abstract Background: Postoperative Upper Gastro-Intestinal Fistula (PUGIF) is a devastating complication, leading to a high mortality rate reaching up to 80%, increased length of hospital stay, reduced Health related quality of life (HRQOL) and increased health costs. Nutritional support is a key component of therapy in such cases, related to the high prevalence of malnutrition. In prophylactic setting, enteral nutrition (EN) is associated to shorter hospital stay, lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery. In curative settingafter fistula occurrence, there are very few evidences available. We hypothesise that EN increases 30-day fistula closure rate in PUGIF, allowing better HRQOL without increasing morbi-mortality. Methods/Design: The NUTRILEAK trial is a multicenter, randomized, parallel-group, open label phase III trial to assess the efficacy of EN (experimental group) compared with TPN (control group) in patients with PUGIF. The primary objective of the study is to compare EN versus TPN in the treatment of PUGIF (after oesophago-gastric resection including bariatric surgery, duodeno-jejunal resection or pancreatic resection with digestive tract violation) in terms of 30-day fistula closure rate. Secondary objectives are to evaluate the 6-month post-randomization fistula closure rate, time of first fistula closure (in days), medical and surgical treatment-related complication rate at 6 months after randomization, fistula related complication rate at 6 months after randomization, type and severity of early (30 days after randomization) and late fistula-related complications (over 30 days after randomization), 30-day and 6-month post-randomization mortality rate, nutritional status at day 30, day 60, day 90 and day 180 post randomization, mean length of hospital stay, patient’s Health related quality of life (HRQOL) (self-assessment questionnaire), oral feeding time anddirect costs of treatment. A total of 321 patients will be enrolled. Discussion: The two nutritional supports are already used in daily practice, but most surgeons are reluctant to use the enteral route in case of PUGIF. This study will be the first randomized trial testing the role of EN versus TPN in PUGIF. Trial registration: ClinicalTrials.gov, NCT03742752. Registered on 14 November 2018.

scholarly journals The efficacy of corticosteroids therapy in patients with moderate to severe SARS-CoV-2 infection: a multicenter, randomized, open-label trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mostafa Ghanei ◽  
Masoud Solaymani-Dodaran ◽  
Ali Qazvini ◽  
Amir Hosein Ghazale ◽  
Seyed Amin Setarehdan ◽  
...  
Keyword(s):  
Hospital Stay ◽  
Length Of Hospital Stay ◽  
Diabetic Patients ◽  
Open Label ◽  
Mitt Population ◽  
Treatment Regimens ◽  
Clinical Recovery ◽  
Group I ◽  
The Mean ◽  
Open Label Trial

Abstract Background We performed a multicenter, randomized open-label trial in patients with moderate to severe Covid-19 treated with a range of possible treatment regimens. Methods: Patients were randomly assigned to one of three regimen groups at a ratio of 1:1:1. The primary outcome of this study was admission to the intensive care unit. Secondary outcomes were intubation, in-hospital mortality, time to clinical recovery, and length of hospital stay (LOS). Between April 13 and August 9, 2020, a total of 336 patients were randomly assigned to receive one of the 3 treatment regimens including group I (hydroxychloroquine stat, prednisolone, azithromycin and naproxen; 120 patients), group II (hydroxychloroquine stat, azithromycin and naproxen; 116 patients), and group III (hydroxychloroquine and lopinavir/ritonavir (116 patients). The mean LOS in patients receiving prednisolone was 5.5 in the modified intention-to-treat (mITT) population and 4.4 days in the per-protocol (PP) population compared with 6.4 days (mITT population) and 5.8 days (PP population) in patients treated with Lopinavir/Ritonavir. Results The mean LOS was significantly lower in the mITT and PP populations who received prednisolone compared with populations treated with Lopinavir/Ritonavir (p = 0.028; p = 0.0007). We observed no significant differences in the number of deaths, ICU admission, and need for mechanical ventilation between the Modified ITT and per-protocol populations treated with prednisolone and Lopinavir/Ritonavir, although these outcomes were better in the arm treated with prednisolone. The time to clinical recovery was similar in the modified ITT and per-protocol populations treated with prednisolone, lopinavir/ritonavir, and azithromycin (P = 0.335; P = 0.055; p = 0.291; p = 0.098). Conclusion The results of the present study show that therapeutic regimen (regimen I) with low dose prednisolone was superior to other regimens in shortening the length of hospital stay in patients with moderate to severe COVID-19. The steroid sparing effect may be utilized to increase the effectiveness of corticosteroids in the management of diabetic patients by decreasing the dosage.

scholarly journals Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open label, phase III study (NUTRILEAK study)

2020 ◽  
Author(s):  
Caroline Gronnier ◽  
Cécile Chambrier ◽  
Alain Duhamel ◽  
Benoît Dervaux ◽  
Denis Collet ◽  
...  
Keyword(s):  
Hospital Stay ◽  
Length Of Hospital Stay ◽  
Phase Iii ◽  
Fistula Closure ◽  
Related Complication ◽  
Open Label ◽  
Closure Rate ◽  
Open Label Phase ◽  
Related Quality ◽  
Health Related

Abstract Background: Postoperative Upper Gastro-Intestinal Fistula (PUGIF) is a devastating complication, leading to a high mortality rate reaching up to 80%, increased length of hospital stay, reduced Health related quality of life (HRQOL) and increased health costs. Nutritional support is a key component of therapy in such cases, related to the high prevalence of malnutrition. In prophylactic setting, enteral nutrition (EN) is associated to shorter hospital stay, lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery. In curative settingafter fistula occurrence, there are very few evidences available. We hypothesise that EN increases 30-day fistula closure rate in PUGIF, allowing better HRQOL without increasing morbi-mortality. Methods/Design: The NUTRILEAK trial is a multicenter, randomized, parallel-group, open label phase III trial to assess the efficacy of EN (experimental group) compared with TPN (control group) in patients with PUGIF. The primary objective of the study is to compare EN versus TPN in the treatment of PUGIF (after oesophago-gastric resection including bariatric surgery, duodeno-jejunal resection or pancreatic resection with digestive tract violation) in terms of 30-day fistula closure rate. Secondary objectives are to evaluate the 6-month post-randomization fistula closure rate, time of first fistula closure (in days), medical and surgical treatment-related complication rate at 6 months after randomization, fistula related complication rate at 6 months after randomization, type and severity of early (30 days after randomization) and late fistula-related complications (over 30 days after randomization), 30-day and 6-month post-randomization mortality rate, nutritional status at day 30, day 60, day 90 and day 180 post randomization, mean length of hospital stay, patient’s Health related quality of life (HRQOL) (self-assessment questionnaire), oral feeding time anddirect costs of treatment. A total of 321 patients will be enrolled. Discussion: The two nutritional supports are already used in daily practice, but most surgeons are reluctant to use the enteral route in case of PUGIF. This study will be the first randomized trial testing the role of EN versus TPN in PUGIF. Trial registration: ClinicalTrials.gov, NCT03742752. Registered on 14 November 2018.

Abstract 4396: Clinical Response to Recombinant Acid α-Glucosidase is Predicted by Cardiac Outcome Measures in Children with Pompe Disease

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Carolyn T Spencer ◽  
Jami Levine ◽  
Deya Corzo ◽  
Steven D Colan ◽  
Dionne Graham ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Pompe Disease ◽  
Young Patients ◽  
Assisted Ventilation ◽  
Open Label ◽  
Enzyme Replacement ◽  
Lv Mass ◽  
Z Scores ◽  
Group A ◽  
Group B

Background : Pompe disease is an autosomal-recessive glycogen storage disease due to deficiency of acid α-glucosidase (GAA). Clinical findings in infantile onset disease are due to glycogen accumulation leading to hypertrophic cardiomyopathy, skeletal myopathy, respiratory failure and death. Enzyme replacement therapy (ERT) with recombinant human GAA (rhGAA; Myozyme®) has been shown to prolong survival in infants. We assessed the hypothesis that myocardial response to rhGAA predicts clinical outcome in Pompe. Methods: Echos during one year of ERT were reviewed from patients enrolled in open label trials of rhGAA (n=38). A standardized echo protocol was used at specific time points (wks 0, 4, 8, 12, 26, 38, 52). A central reader made measurements off-line, blinded to study information. Variables including LV mass, volumes, and ejection fraction (EF) were determined. Clinical outcomes at study-end were analyzed in 2 groups: Group A, alive and free of assisted ventilation (AV) or Group B, died or requiring AV. Z-scores were calculated for all echo variables and median z-scores between outcome groups at wk 0 and wk 52 were compared using median scores tests. Non-linear random effects models were used to examine changes over time. Results: Mean age at first infusion = 10.9±9.8 months (range 1.2 – 43.1). At study onset, 7/38 received AV. At study end, mean time to last infusion = 115±44 weeks with 16/38 in Group A and 22/38 in Group B. For Group A vs. Group B, median z-scores at week 0 for LV mass = 6.11 vs. 7.41, mass to volume ratio (MVR) = 4.5 vs. 8.8, and EF = 0.8 for both groups; p≥ 0.12 for each measure. Median z-scores for the same outcome groups, respectively, at week 52 for LV mass = 0.57 vs. 3.41 (p=0.06), for MVR = 0.48 vs. 3.54 (p=0.001) and EF = −0.6 in both groups. In the subgroup not requiring AV at study onset (n=31), MVR is higher at all times in Group B (p≤ 0.03). Conclusion: rhGAA therapy can prolong life in young patients with Pompe, improving outcome compared to an untreated natural history cohort. Even with ERT, there is significant morbidity and mortality. Diminished myocardial response with persistence of significant LV hypertrophy predicts progression to poor clinical outcomes. These and other predictors are required to fully understand response to ERT in Pompe disease.

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