Efficacy and Safety of Plastic Cannulae Compared with Metal Needles in the Initial Use of an Arteriovenous Fistulae in Incident Hemodialysis Patients: A Randomized Controlled Study

2021 ◽  
pp. 1-8
Author(s):  
Yong Seon Choi ◽  
Hyung Seok Lee ◽  
Narae Joo ◽  
Pyoungju Park ◽  
Seung Nam Cho ◽  
...  
Keyword(s):  
Controlled Study ◽  
Open Label ◽  
Open Label Study ◽  
Vessel Injury ◽  
Secondary Endpoints ◽  
Metal Group ◽  
A New Technique ◽  
Difficulty Score ◽  
Metal Needle

<b><i>Introduction:</i></b> Successful cannulation of an arteriovenous fistula (AVF) is important in patients starting hemodialysis (HD). Metal needles have been used for decades, but the usefulness of plastic cannulae has recently been demonstrated as a new technique. <b><i>Methods:</i></b> This was a prospective, randomized, open-label study of incident HD patients. Eligible patients were randomized into 2 groups in a 1:1 ratio (<i>n</i> = 45/group). Maturation of the AVF was confirmed using Doppler ultrasound prior to first needling, and 2 well-trained nurses implemented the AVF cannulation. The primary endpoint was the initial cannulation failure rate, defined as the failure of successful completion of 3 consecutive dialysis sessions. The secondary endpoints were time for hemostasis at the end of HD, degree of patients’ pain, degree of cannulation difficulty felt by the nursing staffs, and achieving optimal HD adequacy. <b><i>Results:</i></b> The mean elapsed time from AVF creation to the first cannulation was 48.1 ± 16.7 days. A total of 17 cases of cannulation failure occurred, and the failure risk tended to be higher in the metal needle group than the plastic cannula group (hazard ratio 2.6, 95% confidence interval 0.95–7.41) after adjusting for age, gender, comorbidities, and AVF location. The overall incidence of vessel injury was higher and time for hemostasis was significantly longer in the metal group than the plastic group. The use of plastic cannula was associated with a better HD adequacy compared to a metal needle. However, the patients’ pain score (<i>p</i> = 0.004) and nursing staff’s cannulation difficulty score (<i>p</i> = 0.084) were higher in the plastic group, emphasizing the great importance of practice using plastic cannulae. <b><i>Conclusion:</i></b> The vascular outcomes of plastic cannulae were much favorable compared to metal needles in incident HD patients. The use of plastic cannulae could be a new and innovative way to improve the quality of dialysis.

A Phase II Study Of Aprepitant As Anti-Emetic Prophylaxis In Patients Receiving Induction Chemotherapy For AML

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 5035-5035
Author(s):  
Joseph Brandwein ◽  
Karen W.L. WL Yee ◽  
Andre C Schuh ◽  
Vikas Gupta ◽  
Jack T Seki
Keyword(s):  
Induction Chemotherapy ◽  
Phase Ii ◽  
Cumulative Incidence ◽  
Retrospective Cohort ◽  
Phase Iii ◽  
Controlled Study ◽  
Open Label ◽  
Open Label Study ◽  
Secondary Endpoints ◽  
Additional Therapy

Abstract Background Standard AML induction chemotherapy includes an anthracycline plus cytarabine (3+7); the former is considered moderately emetogenic. Such patients typically received anti-emetic prophylaxis using a 5-HT3 antagonist; however, many patients continue to experience chemotherapy-induced nausea and vomiting (CINV) requiring additional therapy. Aprepitant is a neurokinin inhibitor with documented efficacy against CINV, but has not been evaluated to date in the setting of AML induction therapy. Patients and Methods Patients with previously untreated AML, receiving induction chemotherapy with daunorubicin 60 mg/m2 IV daily on Days 1-3 plus cytarabine 200 mg/m2 IV daily (100 mg/m2 for patients age 60 and over) as a continuous IV infusion x 7 days, were enrolled in a Phase II single arm open label study. All patients received 5-HT3 antagonist prophylaxis using either granisetron 1 mg IV daily or ondansetron 8 mg IV q12h on the 3 daunorubicin dosing days. In addition, patients received aprepitant 125 mg PO on Day 1 followed by 80 mg PO daily on Days 2-5. No corticosteroids were used. Additional anti-emetic therapy was given as needed, at the discretion of the medical staff, for any nausea or vomiting. The primary endpoint was any vomiting or retching, while secondary endpoints included nausea requiring supplemental anti-emetics. Results were compared to a retrospective cohort of 40 patients who had received the same AML induction chemotherapy and 5-HT3 antagonist prophylaxis, but without aprepitant. Results At a pre-planned interim analysis, 27 patients receiving aprepitant on study were evaluated. By the end of Day 5, 3/27 patients (11%) had experienced at least one episode of vomiting or retching, while by the end of Day 8 four additional patients had experienced vomiting/retching, for a cumulative incidence of 26%. In comparison, the cumulative incidence of vomiting or retching by the end of Day 5 in the retrospective cohort was 50% (20/40), and 53% by Day 8. The proportion of patients experiencing vomiting was below 8% per day on aprepitant dosing days, but increased to11% on Day 6.  The cumulative incidence of nausea and/or vomiting in the aprepitant group was 52% by the end of Day 5 and 60% at the end of Day 8, as compared to 78% at both time points in the retrospective cohort. There were no toxicities attributable to aprepitant. Conclusion The results indicate that aprepitant is highly effective, when combined with a 5-HT3 antagonist, in preventing vomiting in patients receiving AML induction chemotherapy with 3+7. The combination appears less effective in controlling nausea. The results warrant further evaluation in a Phase III randomized placebo controlled study. Disclosures: Brandwein: Merck: Honoraria, Research Funding. Off Label Use: Aprepitant as anti-emetic prophylaxis for AML induction. Seki:Merck: Honoraria.

scholarly journals Effectiveness and Impact of Capsaicin 8% Patch on Quality of Life in Patients with Lumbosacral Pain: An Open-label Study

2016 ◽  
Vol 7;19 (7;9) ◽  
pp. E1049-E1053 ◽  
Author(s):  
Panagiotis Zis
Keyword(s):  
Quality Of Life ◽  
Neuropathic Pain ◽  
Care Center ◽  
Controlled Study ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Vas Score ◽  
The Impact

Background: Capsaicin 8% patch (Qutenza™) is mainly used to treat postherpetic neuralgia and HIV-associated neuropathy. Evidence of the efficacy of Qutenza in other forms of neuropathic pain is lacking. Objective: To evaluate the analgesic effect and the impact on quality of life after a single application of the capsaicin 8% cutaneous patch in patients with lumbosacral pain. Study Design: Prospective open-label study of capsaicin 8% patch in patients with lumbosacral pain. Setting: Outpatient Pain and Palliative Care Center. Methods: All recruited patients were evaluated prior to capsaicin 8% patch administration and were followed-up at 2 weeks, at 8 weeks, and at 12 weeks post administration. Visual analog scale (VAS) was used to record pain intensity and EQ-5D was used to assess the quality of life of the participants. Results: Ninety patients met our inclusion criteria (54.4% men, mean age 59.1 ± 9.2 years). At baseline the mean VAS score of the participants was 7.6 ± 0.7. A statistically significant reduction of the VAS score between baseline and week 2 (mean VAS score 5.6 ± 1.1, P < 0.001) was observed. The therapeutic effect further continued between week 2 and week 8 (mean VAS score 3.2 ± 1.2, P < 0.001) and between week 8 and at endpoint at week 12 (mean VAS score 2.6 ± 1.1, P < 0.001). Between baseline and weeks 2, 8, and 12 (end-point) a significant improvement in all 5 dimensions of EQ-5D (mobility, self-care, usual activities, pain/discomfort, and anxiety/ depression) was observed (P < 0.001) Limitations: As it is an open-label study, a prospective randomized placebo-controlled study should be designed to confirm the effectiveness of capsaicin 8% patch in patients with lumbosacral pain. Conclusions: Administration of the capsaicin 8% patch resulted in a significant relief of neuropathic pain and a significant improvement of the quality of life of patients with lumbosacral neuropathic pain. Key words: Lumbosacral pain, peripheral pain, Qutenza, neuropathic pain, capsaicin, patch, quality of life, effectiveness

485 Efficacy and Safety of Once- and Twice-Nightly Dosing of Lower-Sodium Oxybate in Adults With Idiopathic Hypersomnia

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A191-A192
Author(s):  
Isabelle Arnulf ◽  
Anne Marie Morse ◽  
Patricia Chandler ◽  
Rupa Parvataneni ◽  
Dan Chen ◽  
...  
Keyword(s):  
Sodium Oxybate ◽  
Mean Difference ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Patient Global Impression ◽  
Idiopathic Hypersomnia ◽  
Secondary Endpoints ◽  
Global Impression Of Change

Abstract Introduction Idiopathic hypersomnia (IH) is a rare central hypersomnolence disorder. In a randomized, controlled study of lower-sodium oxybate (LXB; Xywav™) in adults with IH (NCT03533114), significant differences for LXB compared with placebo were observed in Epworth Sleepiness Scale (ESS; primary efficacy endpoint), self-reported Patient Global Impression of Change (PGIc), and IH Severity Scale (IHSS; key secondary endpoints). In this clinical study, investigators were permitted to initiate LXB dosing on a once-nightly or twice-nightly regimen. Methods Eligible participants aged 18–75 years began LXB treatment, administered once or twice nightly during an open-label treatment/titration and optimization period (OLTTOP; 10–14 weeks); dose amount/regimen could be adjusted during this period. Participants next entered a 2-week, open-label, stable-dose period (SDP), then were randomized to placebo or to continue LXB treatment during a 2-week, double-blind, randomized withdrawal period (DBRWP). P values are nominal for this exploratory analysis. Results Of 154 enrolled participants, 40 (26%) initiated LXB treatment on a once-nightly regimen. In the efficacy population (n=115), 27 participants were on a once-nightly regimen during SDP (48.1% of whom initiated treatment once nightly during OLTTOP) and 88 participants were on a twice-nightly regimen during SDP (86.4% of whom initiated treatment twice nightly during OLTTOP). During SDP, median (min, max) LXB total dose was 4.5 (2.5, 6) g/night (once-nightly group) and 7.5 (4.5, 9) g/night (twice-nightly group). ESS scores worsened in participants randomized to placebo vs those continuing LXB in the once-nightly group (n=11 and n=15, respectively; LS mean difference [95% CI]: −4.93 [−7.41, −2.46]; P=0.0004) and twice-nightly group (n=47 and n=41, respectively; LS mean difference [95% CI]: −7.44 [−9.15, −5.72]; P&lt;0.0001). Worsening was also observed in PGIc (once-nightly: 81.8% [placebo] vs 26.7% [LXB]; P=0.0077; twice-nightly: 89.4% [placebo] vs 19.5% [LXB]; P&lt;0.0001) and IHSS score (estimated median difference [95% CI], once-nightly: −9.00 [−16.0, −3.0]; P=0.0028; twice-nightly: −12.00 [−15.0, −8.0]; P&lt;0.0001). Common adverse events included nausea (21.4%), headache (16.2%), anxiety (14.9%), dizziness (11.7%), insomnia (11.7%), and vomiting (10.4%). Conclusion The efficacy and safety of LXB in IH were demonstrated for both once-nightly and twice-nightly regimens. The majority of participants initiated and remained on a twice-nightly regimen. Support (if any) Jazz Pharmaceuticals

The effect of bosentan in patients with a failing Fontan circulation

2009 ◽  
Vol 19 (4) ◽  
pp. 331-339 ◽  
Author(s):  
Caroline Ovaert ◽  
Daisy Thijs ◽  
Daniel Dewolf ◽  
Jaap Ottenkamp ◽  
Hugues Dessy ◽  
...  
Keyword(s):  
Statistical Significance ◽  
Fontan Operation ◽  
Tertiary Care ◽  
Blood Chemistry ◽  
Hepatic Function ◽  
Fontan Circulation ◽  
Controlled Study ◽  
Open Label ◽  
Failing Fontan

AbstractObjectivesTo investigate the effect of bosentan in patients with a failing Fontan circulation.DesignA multicentric open label, non-controlled study.Setting5 tertiary care centres for congenital cardiology.PatientsWe included 10 patients with a failing Fontan circulation. Their median age at inclusion was 12.12 years, with a range from 4.41 to 33,41 years. The median interval between the Fontan operation and inclusion was 7.84 years, with a range from 1.96 to 12,18 years. Participants received half the usual dose of bosentan for 4 weeks, and then the full dose for a further 12 weeks.Main measures of outcomesWe assessed saturations of oxygen at rest and during exercise, using a 6 minutes walk test, at baseline, and during and after 16 weeks of treatment. At each visit, we assessed blood chemistry and hepatic function, and asked the patients to complete a questionnaire concerning quality of life. All medical events and possible side effects were recorded.ResultsOf the cohort, 1 patient withdrew. The changes in saturations of oxygen, exercise performance, and scores for the questionnaire did not reach statistical significance for the whole group. We noted, nonetheless, that saturations of oxygen and/or exercise capacity improved in 5 of the patients. This was further confirmed when those patients deteriorated again when the drug was discontinued.ConclusionsOur study failed to show significant improvement after 3 months of treatment with bosentan in a small group of patients with failing Fontan circulations. Some individuals, nonetheless, did improve. When planning larger trials, it would be better to identify those patients who might potentially benefit from the treatment prior to commencing the trial.

The premonitory phase of migraine and migraine management

Cephalalgia ◽  
2012 ◽  
Vol 33 (13) ◽  
pp. 1117-1121 ◽  
Author(s):  
Werner J Becker
Keyword(s):  
Literature Review ◽  
Migraine Attack ◽  
Management Strategy ◽  
Controlled Study ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Medication Treatment ◽  
Premonitory Symptoms

Objective: The objective was to determine, through a literature review, whether treatment during the premonitory phase of migraine is a potentially useful migraine management strategy. Methods: A general literature review was done with regard to the nature of migraine premonitory symptoms, their frequency, their reliability in predicting migraine attacks, and the effectiveness of medication treatment when given during the premonitory phase. Results: Many different symptoms have been reported as premonitory symptoms that occur before migraine attacks. Up to 87% of patients with migraine may experience premonitory symptoms, although some studies have provided estimates as low as 33%. In selected patients, premonitory symptoms may be relatively reliable predictors of a migraine attack to follow. Both naratriptan (open-label study) and domperidone (double-blind, randomized, placebo-controlled study) have been reported to be effective when given during the premonitory phase. Conclusions: More research is needed, but there is some evidence that medication treatment during the premonitory phase has the potential to be helpful in selected patients with migraine.

scholarly journals Pilot trial on the efficacy and safety of pantethine in children with pantothenate kinase-associated neurodegeneration: A single-arm, open-label study.

2020 ◽  
Author(s):  
Xuting Chang ◽  
Jie Zhang ◽  
Yuwu Jiang ◽  
Bufan Yao ◽  
Jingmin Wang ◽  
...  
Keyword(s):  
Rating Scale ◽  
Pilot Trial ◽  
Motor Dysfunction ◽  
Efficacy And Safety ◽  
Open Label ◽  
Pantothenate Kinase ◽  
Open Label Study ◽  
Label Study ◽  
Video Assessment

Abstract Objective This study aimed to explore the efficacy and safety of pantethine in children with pantothenate kinase-associated neurodegeneration (PKAN).Methods A single-arm, open-label study was conducted. All subjects received pantethine during the 24-week period of treatment. The primary endpoints were change of the Unified Parkinson’s Disease Rating Scale (UPDRS) I–III and Fahn–Marsden (FM) score from baseline to week 24 after treatment.Results Fifteen children with PKAN were enrolled, and all patients completed the study. After 24 weeks of treatment with pantethine at 60 mg/kg per day, there was no difference in either UPDRS I–III (t = 0.516, P = 0.614) or FM score (t = 0.353, P = 0.729) between the baseline and W24. Whereas the rates of increase in UPDRS I-III (Z = 2.614, p = 0.009) and FM scores (Z = 2.643, p = 0.008) were slowed. Four patients (26.7%) were evaluated as “slightly improved” by doctors through blinded video assessment. Patients with lower baseline UPDRS I–III or FM scores were more likely to be improved. The living quality of family members improved after pantethine treatment, evaluated by PedsQL TM 2.0 FIM scores, whereas the living quality of the patients was unchanged at W24, evaluated by PedsQL TM 4.0 and PedsQL TM 3.0 NMM. Serum level of CoA was comparable between baseline and W24. There was no drug related adverse event during the study.Conclusions Pantethine could not significantly improve motor function in children with PKAN after 24 weeks treatment, but it could probably delay the progression of motor dysfunction in our study. 26.7% of patients showed slightly improved. Pantethine was well-tolerated at 60 mg/kg per day.

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