Safety and Efficacy of Multi-chamber Bag Parenteral Nutrition

2021 ◽  
Author(s):  
Muna Islami ◽  
Mohammad Alsharhan ◽  
Areej Alfattani ◽  
Manar Alawwad ◽  
Haya Almeshari
Keyword(s):  
Parenteral Nutrition ◽  
Treatment Period ◽  
Significant Degree ◽  
Normal Weight ◽  
Target Protein ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Inclusion Criteria ◽  
King Faisal Specialist Hospital ◽  
Electrolyte Abnormalities

Abstract Background There is a significant degree of debate regarding the use of standardized parenteral solutions. Multi-chamber bag parenteral nutrition (MCB-PN) showed advantages over compounded PN in previous literature. Meanwhile, some literature has shown the limitations in use of MCB-PN. This study was conducted to evaluate the nutritional efficacy and safety of commercially available MCB-PN.Methods All adult hospitalized patients who have been on MCB-PN for at least seven consecutive days at King Faisal Specialist Hospital & Research Center in Riyadh from January 2015 until December 2019 were included. Laboratory parameters were evaluated before PN started, which was used as a baseline, and every seven days while on PN. Primary outcomes were the percentage of patients who achieved calculated target calories and protein and the percentage of patients who developed electrolyte abnormalities. The secondary outcome was a percentage of adverse drug reactions during the treatment period.Results Two hundred and thirty-one patients met the inclusion criteria. Among the included subjects, 101 (44%) achieved target calories; 29 (12.6%) were underweight; 40 (17.3%) were normal weight; 18 (7.8%) were overweight; and 14 (6.1%) were in obese subgroups, with p-value 0.145. Sixty-eight (29.6%) achieved the target protein dose; 26 (11.3%) were underweight; 33 (14.3%) were normal weight; five (2.2%) were overweight; and four (1.7%) were in obese subgroups, with p-value < 0.01. One hundred and ninety-one (83.4%) developed electrolyte imbalances; 39 (16.9%) were underweight; 87 (37.7%) were normal weight; 34 (14.7%) were overweight; and 34 (14.7%) were in obese subgroups, with p-value 0.085, during the treatment period. A small percentage of ADRs and metabolic abnormalities were reported during the treatment period.Conclusion Among patients receiving MCB-PN, only 44% achieved the caloric target, and 29.6% achieved the target protein dose with fewer percentages of ADRs.

scholarly journals The efficacy and safety of Ivermectin in patients with mild and moderate COVID-19: A structured summary of a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Fatemeh Sadat Hosseini ◽  
Alireza Malektojari ◽  
Sara Ghazizadeh ◽  
Mehdi Hassaniazad ◽  
Parivash Davoodian ◽  
...  
Keyword(s):  
Informed Consent ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
List Type ◽  
Efficacy And Safety ◽  
Inclusion Criteria ◽  
Control Groups ◽  
Open Label ◽  
Outpatient Group ◽  
Full Protocol

Abstract Objectives We will evaluate the efficacy and safety of Ivermectin in patients with mild and moderately severe COVID-19. Trial design This is a phase 3, single-center, randomized, open-label, controlled trial with a 2-arm parallel-group design (1:1 ratio). Participants The Severe Acute Respiratory Syndrome Departments of the Shahid Mohammadi Hospital, Bandar Abbas, Iran, will screen for patients age ≥ 20 years and weight ≥35 kg for the following criteria: Inclusion criteria for patients with mild COVID-19 symptoms (outpatients) Diagnosed mild pneumonia using computed tomography (CT) and/or chest X-ray (CX-R) imaging, not requiring hospitalization. Signing informed consent. Inclusion criteria for patients with moderate COVID-19 symptoms (inpatients) Confirmed infection using PCR. Diagnosed moderate pneumonia using CT and/or CXR imaging, requiring hospitalization. Hospitalized ≤ 48 hours. Signing informed consent. Exclusion criteria Severe and critical pneumonia due to COVID-19. Underlying diseases, including AIDS, asthma, loiasis, and severe liver and kidney disease. Use of anticoagulants (e.g., warfarin) and ACE inhibitors (e.g., captopril). History of drug allergy to Ivermectin. Pregnancy or breastfeeding. Intervention and comparator Intervention groups: Outpatient and inpatient groups will receive the standard treatment regimen for mild and moderate COVID-19, based on the Iranian Ministry of Health and Medical Education's protocol, along with oral Ivermectin (MSD Company, France) at a single dose of 0.2 mg/kg. Control groups: The outpatient group will receive hydroxychloroquine sulfate (Amin Pharmaceutical Company, Iran) at a dose of 400 mg twice a day for the first day and 200 mg twice a day for seven subsequent days. The inpatient group will receive 200/50 mg Lopinavir/Ritonavir (Heterd Company, India) twice a day for the seven days, plus five doses of 44 mcg Interferon beta-1a (CinnaGen, Iran) every other day. Other supportive and routine care will be the same in both outpatient and inpatient groups. Main outcome The primary outcomes are composite and include the improvement of clinical symptoms and need for hospitalization for outpatient groups, and the length of hospital stay until discharge, the need for ICU admission until discharge, and the need for mechanical ventilation for inpatient groups within seven days of randomization. The secondary outcome is the incidence of serious adverse drug reactions within seven days of randomization. Randomization Patients in both outpatient (mild) and inpatient (moderate) groups will be randomized into the treatment and control groups based on the following method. A simple randomization method and table of random numbers will be used. If the selected number is even, the patient is allocated to the treatment group, and if it is odd, the patient is allocated to the control group in a 1:1 ratio. Blinding (masking) This is an open-label study, and there is not blinding. Numbers to be randomized (sample size) A total number of 120 patients (60 outpatients and 60 patients) will be randomized into two groups (30 patients in each of the intervention groups and 30 patients in each of the control groups). Trial Status The protocol is Version 1.0, November 17, 2020. Recruitment began November 25, 2020, and is anticipated to be completed by February 25, 2021. Trial registration This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is “IRCT20200506047323N6”. The registration date is November 17, 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.

Efficacy of ethanol ablation for treatment of benign cystic thyroid nodules: the first hospital-based study in Vietnam

MedPharmRes ◽  
2020 ◽  
Vol 4 (1) ◽  
pp. 18-22
Author(s):  
Van Bang Nguyen ◽  
Van Vy Hau Nguyen ◽  
Binh Thang Tran ◽  
Chi Van Le
Keyword(s):  
Thyroid Nodules ◽  
Multiple Logistic Regression Analysis ◽  
Volume Reduction ◽  
Efficacy And Safety ◽  
Inclusion Criteria ◽  
Ethanol Ablation ◽  
Institutional Review ◽  
Thyroid Cyst ◽  
Secondary Endpoints ◽  
Written Informed Consent

Background: In Vietnam, surgery or aspiration is preferred to treat thyroid cysts however each of them still have limitations. Purposes of this study were to evaluate the efficacy and safety of ethanol ablation in treating thyroid cysts and determine factors that predict the outcome of treatment. Methods: This prospective study was approved by the Ethics Committee of the Institutional Review Board of Family hospital and written informed consent for procedures was obtained. From May 2018 to March 2019, 23 patients who underwent treatment for thyroid cysts by EA were enrolled in this study and were followed up for 1 month at Family hospital. The primary endpoint was efficient after one month as the volume reduction ratio was ≥ 50%. Secondary endpoints were improvements in symptoms, cosmetic scores, and safety. Multiple logistic regression analysis was used. Results: In the finding, from May 2018 to March 2019, only 17 patients who matched inclusion criteria were included in the analyst, including 7 purely thyroid cysts, and 10 predominantly cystic nodules. Mean volume decreased significantly from 5.21 ± 3.37 ml to 2.35 ± 2.52 ml in corresponding to 52.87% of volume reduction with p < 0.05. Ethanol ablation (EA) success rate was 52.90% after 1 month. Symptoms and cosmetic scores were improved significantly. The thyroid function was constant. No adverse events occurred. Purely thyroid cyst was a predictive factor contributing to the success of EA. Conclusion: EA seems likely to be a safe and an efficient therapy for patients who had purely or predominantly cystic thyroid nodules.

scholarly journals Comparison of clinical efficacy and safety between dexmedetomidine and propofol among patients undergoing gastrointestinal endoscopy: a meta-analysis

2021 ◽  
Vol 49 (7) ◽  
pp. 030006052110327
Author(s):  
Weihua Liu ◽  
Wenli Yu ◽  
Hongli Yu ◽  
Mingwei Sheng
Keyword(s):  
Clinical Efficacy ◽  
Lower Risk ◽  
Gastrointestinal Endoscopy ◽  
Weighted Mean Difference ◽  
Meta Analysis ◽  
Similar Efficacy ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Inclusion Criteria ◽  
Weighted Mean

Objective To compare the clinical efficacy and safety of dexmedetomidine and propofol in patients who underwent gastrointestinal endoscopy. Methods Relevant studies comparing dexmedetomidine and propofol among patients who underwent gastrointestinal endoscopy were retrieved from databases such as PubMed, Embase, and Cochrane Library. Results Seven relevant studies (dexmedetomidine group, n = 238; propofol group, n = 239) met the inclusion criteria. There were no significant differences in the induction time (weighted mean difference [WMD] = 3.46, 95% confidence interval [CI] = −0.95–7.88, I2 = 99%) and recovery time (WMD = 2.74, 95% CI = −2.72–8.19, I2 = 98%). Subgroup analysis revealed no significant differences in the risks of hypotension (risk ratio [RR] = 0.56, 95% CI = 0.25–1.22) and nausea and vomiting (RR = 1.00, 95% CI = 0.46–2.22) between the drugs, whereas dexmedetomidine carried a lower risk of hypoxia (RR = 0.26, 95% CI = 0.11–0.63) and higher risk of bradycardia (RR = 3.01, 95% CI = 1.38–6.54). Conclusions Dexmedetomidine had similar efficacy and safety profiles as propofol in patients undergoing gastrointestinal endoscopy.

scholarly journals Efficacy and safety of anti-epidermal growth factor receptor agents for the treatment of oesophageal cancer: a systematic review and meta-analysis

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e046352
Author(s):  
Lijuan Zhang ◽  
Yanli Song ◽  
Nan Jiang ◽  
Yaqi Huang ◽  
Bo Dong ◽  
...  
Keyword(s):  
Systematic Review ◽  
Growth Factor ◽  
Outcome Measures ◽  
Oesophageal Cancer ◽  
Meta Analysis ◽  
Growth Factor Receptor ◽  
Cochrane Library ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Positive Effects

ObjectivesDespite remarkable advances in the treatment of oesophageal cancer (OC), the role of antiepidermal growth factor receptor (anti-EGFR) agents in treating OC remains controversial. Herein, a systematic review and meta-analysis were conducted to elucidate the efficacy and safety of anti-EGFR agents in patients with OC.DesignMeta-analysis of randomised controlled trials (RCTs) identified by searching the PubMed, Embase, Web of Science, ClinicalTrials.gov, Cochrane Library, Chinese Biology Medicine, China National Knowledge Infrastructure and Wanfang Data Knowledge Service Platform databases from inception to December 2019. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.SettingRCTs from any country and healthcare setting.ParticipantsPatients with OC.InterventionsCombination therapy with anti-EGFR agents and conventional treatments versus conventional treatments alone in patients with OC.Primary and secondary outcome measuresOverall survival (OS) and progression-free survival (PFS) were primary outcome measures, and objective response rate (ORR), disease control rate (DCR) and treatment toxicities were secondary outcome measures.ResultsIn total, 25 RCTs comprising 3406 patients with OC were included. Overall, anti-EGFR treatment significantly improved the OS (HR: 0.81, 95% CI 0.74 to 0.89, p<0.00001), ORR (relative risk (RR): 1.33, 95% CI 1.16 to 1.52, p<0.0001) and DCR (RR: 1.22, 95% CI 1.11 to 1.34, p<0.0001) but not PFS (HR: 0.91, 95% CI 0.76 to 1.08, p=0.26). Anti-EGFR treatment was significantly associated with higher incidences of myelosuppression, diarrhoea, acne-like rash and hypomagnesaemia.ConclusionsOverall, anti-EGFR agents have positive effects on OS, the ORR and DCR in OC. However, considering the high incidence of adverse effects, such as myelosuppression, diarrhoea, acne-like rashes and hypomagnesaemia, careful monitoring of patients with OC is recommended during anti-EGFR treatment.Trial registration numberCRD42020169230.

scholarly journals Randomized comparison between dexmedetomidine–remifentanil and midazolam–fentanyl for deep sedation during catheter ablation of atrial fibrillation

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Young Choi ◽  
Sung-Hwan Kim ◽  
Ju Youn Kim ◽  
Youmi Hwang ◽  
Tae-Seok Kim ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Positive Pressure ◽  
Efficacy And Safety ◽  
Af Ablation ◽  
Hemodynamic Compromise ◽  
3D Mapping System ◽  
Sedative Agents

Abstract Background and objectives The efficacy of dexmedetomidine for radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF) has not been well established. We evaluated the efficacy and safety of sedation using dexmedetomidine with remifentanil compared to conventional sedative agents during RFCA for AF. Subjects and methods A total of 240 patients undergoing RFCA for AF were randomized to either the dexmedetomidine (DEX) group (continuous infusion of dexmedetomidine and remifentanil) or the midazolam (MID) group (intermittent injections of midazolam and fentanyl) according to sedative agents. Non-invasive positive pressure ventilation was applied to all patients during the procedure. The primary outcome was patient movement during the procedure resulting in a 3D mapping system discordance, and the secondary outcome was adverse events including respiratory or hemodynamic compromise. Results During AF ablation, the incidence of the primary outcome was significantly reduced for the DEX group (18.2% vs. 39.5% in the DEX and the MID groups, respectively, p < 0.001). The frequency of a desaturation event (oxygen saturation < 90%) did not significantly differ between the two groups (6.6% vs. 1.7%, p = 0.056). However, the incidences of hypotension not owing to cardiac tamponade (systolic blood pressure < 80 mmHg, 19.8% vs. 8.4%, p = 0.011) and bradycardia (HR < 50 beats/min: 39.7% vs. 21.8%, p = 0.003) were higher in the DEX group. All efficacy and safety results were consistent within the predefined subgroups. Conclusion The combined use of dexmedetomidine and remifentanil provides higher stability sedation during AF ablation, but can lead to more frequent hemodynamic compromise compared to midazolam and fentanyl.

scholarly journals Children’s moderate-to-vigorous physical activity on weekdays versus weekend days: a multi-country analysis

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Keith Brazendale ◽  
◽  
Michael W. Beets ◽  
Bridget Armstrong ◽  
R. Glenn Weaver ◽  
...  
Keyword(s):  
Physical Activity ◽  
Weight Status ◽  
Vigorous Physical Activity ◽  
Normal Weight ◽  
Analytical Models ◽  
Accelerometer Data ◽  
Inclusion Criteria ◽  
Total Wear ◽  
Valid Data ◽  
Country Analysis

Abstract Purpose The Structured Days Hypothesis (SDH) posits that children’s behaviors associated with obesity – such as physical activity – are more favorable on days that contain more ‘structure’ (i.e., a pre-planned, segmented, and adult-supervised environment) such as school weekdays, compared to days with less structure, such as weekend days. The purpose of this study was to compare children’s moderate-to-vigorous physical activity (MVPA) levels on weekdays versus weekend days using a large, multi-country, accelerometer-measured physical activity dataset. Methods Data were received from the International Children’s Accelerometer Database (ICAD) July 2019. The ICAD inclusion criteria for a valid day of wear, only non-intervention data (e.g., baseline intervention data), children with at least 1 weekday and 1 weekend day, and ICAD studies with data collected exclusively during school months, were included for analyses. Mixed effects models accounting for the nested nature of the data (i.e., days within children) assessed MVPA minutes per day (min/day MVPA) differences between weekdays and weekend days by region/country, adjusted for age, sex, and total wear time. Separate meta-analytical models explored differences by age and country/region for sex and child weight-status. Results/findings Valid data from 15 studies representing 5794 children (61% female, 10.7 ± 2.1 yrs., 24% with overweight/obesity) and 35,263 days of valid accelerometer data from 5 distinct countries/regions were used. Boys and girls accumulated 12.6 min/day (95% CI: 9.0, 16.2) and 9.4 min/day (95% CI: 7.2, 11.6) more MVPA on weekdays versus weekend days, respectively. Children from mainland Europe had the largest differences (17.1 min/day more MVPA on weekdays versus weekend days, 95% CI: 15.3, 19.0) compared to the other countries/regions. Children who were classified as overweight/obese or normal weight/underweight accumulated 9.5 min/day (95% CI: 6.9, 12.2) and 10.9 min/day (95% CI: 8.3, 13.5) of additional MVPA on weekdays versus weekend days, respectively. Conclusions Children from multiple countries/regions accumulated significantly more MVPA on weekdays versus weekend days during school months. This finding aligns with the SDH and warrants future intervention studies to prioritize less-structured days, such as weekend days, and to consider providing opportunities for all children to access additional opportunities to be active.

scholarly journals Flap fixation in preventing seroma formation after mastectomy: an updated meta-analysis

2021 ◽  
Author(s):  
Nunzio Velotti ◽  
Gennaro Limite ◽  
Antonio Vitiello ◽  
Giovanna Berardi ◽  
Mario Musella
Keyword(s):  
Meta Analysis ◽  
Seroma Formation ◽  
Secondary Outcome ◽  
Axillary Lymph ◽  
Breast Cancer Patients ◽  
Inclusion Criteria ◽  
Effective Technique ◽  
Strong Evaluation ◽  
Flap Fixation

AbstractSeroma formation following mastectomy is one of the most experienced complications, with a very variable incidence ranging from 3 to 90%. In recent years, many publications have been realized to define an effective technique to prevent its formation and several approaches have been proposed. Given the potential of flap fixation in reducing seroma formation, we performed a meta-analysis of the literature to investigate the role of this approach as definitive gold standard in mastectomy surgery. Inclusion criteria regarded all studies reporting on breast cancer patients undergoing mastectomy with or without axillary lymph node dissection; studies that compared mastectomy with flap fixation to mastectomy without flap fixation were selected. Papers were eligible for inclusion if outcome was described in terms of seroma formation. As secondary outcome, also surgical site infection (SSI) was evaluated. The included studies were 12, involving 1887 female patients: 221/986 (22.41%) patients experienced seroma formation after flap fixation and 393/901 (43.61%) patients had this complication not receiving flap fixation, with a significant statistical difference between the two groups (OR = 0.267, p = 0.001, 95% CI 0.153, 0.464). About, SSI 59/686 (8.6%) in flap fixation group and 67/686 (9.7%) in patients without flap fixation, with no statistical differences between groups (OR = 0.59, p = 0.056, 95% CI 0.344, 1.013).The heterogeneity between included studies does not allow us to reach definitive conclusions but only to suggest the strong evaluation of this approach after mastectomy in seroma preventing and SSI reduction.

scholarly journals COST-EFFECTIVENESS ANALYSIS ON THE USE OF PARENTERAL NUTRITION WITH D10-CA GLUCONATE AND D5 1/4NS IN NORMAL-WEIGHT NEONATES WITH RESPIRATORY DISTRESS SYNDROME

2017 ◽  
Vol 9 ◽  
pp. 63
Author(s):  
Fitria Ningsih ◽  
Rani Sauriasari ◽  
Agusdini Banun Saptaningsih
Keyword(s):  
Cost Effectiveness ◽  
Parenteral Nutrition ◽  
Respiratory Distress Syndrome ◽  
Respiratory Distress ◽  
Distress Syndrome ◽  
Medical Costs ◽  
Pulse Frequency ◽  
Normal Weight ◽  
Average Weight ◽  
Direct Medical Costs

Objectives: This retrospective cohort study aimed to compare the cost-effectiveness of using D10-CaGluconate and D5 1/4NS preparations in normalweightneonatal patients with Respiratory Distress Syndrome (RDS) in Kambang General Hospital, Jambi, Indonesia.Methods: The research was conducted from September 2014 to June 2015. The study participants were divided into two groups; D10-CaGluconatewas administered to 40 patients and D5 1/4NS to 43 patients. Effectiveness was assessed based on the changes in the physical examination results,average weight gain (28.48 and 23.49 g/day), blood glucose levels (26.73 and 26.42 mg/dL), respiratory rate (−12.35 breaths/minute and −7.77breaths/minute), pulse frequency (−10.98 and −8.07 ±), and body temperature (0.013°C and 0.012°C) of the patients in the D10-CaGluconate andD5 1/4NS groups, respectively.Results: The average direct medical costs of using D10-CaGluconate and D5 1/4NS were 458,290 IDR and 408,347 IDR, respectively. The average costeffectivenessratio value of total direct medical costs for D10-CaGluconate preparation was 35,207,467 IDR while that for D5 1/4NS was 33,958,602IDR. The direct medical cost of the incremental cost-effectiveness ratio mean value of the D5 1/4NS preparation that compared to the D10-CaGluconatepreparation was 10,017,210 IDR.Conclusions: The parenteral nutrition preparation of D10-CaGluconate is more cost-effective than that of D5 1/4NS.

scholarly journals Comparison of efficacy and safety between electroacupuncture at ‘four sacral points’ and conventional electroacupuncture for the treatment of urinary incontinence after stroke: study protocol for a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (11) ◽  
pp. e021783 ◽  
Author(s):  
Shan Chen ◽  
Siyou Wang ◽  
Lihua Xuan ◽  
Hanti Lu ◽  
Zhikai Hu ◽  
...  
Keyword(s):  
Urinary Incontinence ◽  
Randomised Controlled Trial ◽  
Medical Care ◽  
Outcome Measures ◽  
Pudendal Nerve ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Routine Medical Care ◽  
Randomised Controlled

IntroductionElectroacupuncture at ‘four sacral points’, also known as electrical pudendal nerve stimulation therapy, combines the advantages of pudendal nerve neuromodulation and the technique of deep insertion of long acupuncture needles. It has been used to treat stress urinary incontinence, female urgency-frequency syndrome, idiopathic urgency urinary incontinence and neurological bladders in previous studies. Here, we describe the protocol for a randomised controlled trial for evaluation of the efficacy and safety of electroacupuncture at ‘four sacral points’ for the management of urinary incontinence after stroke.Methods and analysisThis is an open-label randomised controlled trial with blinded assessments and analyses. A total of 140 eligible patients will be randomly allocated to two groups. The treatment group (n=70) will receive electroacupuncture at ‘four sacral points’ along with routine medical care, while the control group will receive conventional electroacupuncture along with routine medical care. Twenty treatment sessions will occur over a period of 4 weeks. The primary outcome measures will be the self-recorded findings in an incontinent episode diary at baseline and at 4 weeks after baseline. The secondary outcome measures will be the International Consultation on Incontinence Questionnaire Urinary Incontinence—Short Form (ICIQ-UI SF) score and the Barthel Activities of Daily Living Index (Barthel ADL Index) score at baseline and at 4 and 28 weeks after baseline.Ethics and disseminationThis protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (approval No. 2018-K-059–01). Written informed consent will be obtained from each participant. The results of the study will be published in peer-reviewed journals.Trial registration numberChiCTR-IOR-17012847; Pre-result.

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