Isonatric Dialysis Biofeedback in Hemodiafiltration with Online Regeneration of Ultrafiltrate in Hypertensive Hemodialysis Patients: A Randomized Controlled Study

2015 ◽  
Vol 41 (1-3) ◽  
pp. 87-93 ◽  
Author(s):  
Louise Chevalier ◽  
Christian Tielemans ◽  
Frederic Debelle ◽  
Dominique Vandervelde ◽  
Christine Fumeron ◽  
...  
Keyword(s):  
Arterial Hypertension ◽  
Randomized Study ◽  
Dry Weight ◽  
Hemodialysis Patients ◽  
Controlled Study ◽  
Hypertension Control ◽  
Open Label ◽  
Randomized Controlled ◽  
Short Summary ◽  
The Impact

Dialysis biofeedback in hemodiafiltration with online regeneration of ultrafiltrate (HFR) could help to improve arterial hypertension. We evaluated the impact of isonatric HFR (HFR-iso) on hypertension control compared to conventional HFR. Forty-seven hemodialysis patients were included and randomized (ratio 2/1) HFR-iso versus HFR during 24 dialysis sessions. In the HFR-iso group (32 patients, 768 dialysis sessions), the predialytic systolic blood pressure (BP) decreased from S1 to S24 of 9 ± 20 mm Hg and increased of 5 ± 24 mm Hg in the HFR group (15 patients, 360 dialysis sessions), variation that differed between the 2 groups (ΔS1-S24, p = 0.035; interaction group*time, p = 0.012). The diastolic BP (HFR-iso -3 ± 14 mm Hg vs. HFR 5 ± 13 mm Hg; p = 0.088), the DDD of antihypertensive treatment and the dry weight did not vary significantly during the study. Number of sessions complicated by symptomatic hypotension was similar in the 2 groups. HFR-iso improved BP control without increasing dialysis hypotension episodes. Short Summary: In this multicenter, open-label, controlled, randomized study, we evaluated the impact of dialysis biofeedback in HFR on arterial hypertension compared to conventional HFR. We observed that HFR-iso improved arterial BP control without increasing dialysis hypotension episodes.

scholarly journals A new fat-dissociation method to detect lymph nodes in colorectal cancer: a prospective randomized study

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Shiki Fujino ◽  
Norikatsu Miyoshi ◽  
Masayuki Ohue ◽  
Aya Ito ◽  
Masayoshi Yasui ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Lymph Nodes ◽  
Randomized Study ◽  
Survival Rates ◽  
Controlled Study ◽  
Open Label ◽  
Cancer Specific Survival ◽  
Free Survival ◽  
Randomized Controlled ◽  
Time Required

AbstractHistological examination of the lymph nodes (LNs) is crucial to determine the colorectal cancer (CRC) stage. We previously reported a new fat-dissociation method (FM) to detect LNs from surgically resected mesentery. This study aimed to examine the effectiveness of FM compared with that of conventional palpation method (PM) in CRC. This single-center, open-label, randomized controlled study was performed at Osaka International Cancer Institute in Japan in 2014. Randomization was performed using a computer-generated permuted-block sequence. Patients were stratified by surgical procedures and the LN dissection area. The primary endpoint was the time required for LN identification. The secondary endpoint was the number of LNs and 5-year cancer-specific survival. The 130 enrolled patients were randomly assigned in a 1:1 ratio to the FM and the PM groups. LN identification times were 45 (range 15–80) and 15 (range 7–30) minutes in the PM and the FM groups, respectively (P < 0.001). In the PM group, body mass index and identification time were correlated (P = 0.047). The number of LN which could be examined pathologically was 16 (range 2–48) and 18 (range 4–95) in the PM and FM groups, respectively (P = 0.546). In right-sided CRC, the number of LNs was higher in the FM group than in the PM group (P = 0.031). Relapse-free survival rates and cancer-specific survival rates did not differ between the groups. In conclusion, FM reduced the time required for LN detection without reducing the number of detected LNs, making it is a useful method to detect LNs in surgical specimens.

Longterm Survival Among Patients with Scleroderma-associated Pulmonary Arterial Hypertension Treated with Intravenous Epoprostenol

2009 ◽  
Vol 36 (10) ◽  
pp. 2244-2249 ◽  
Author(s):  
DAVID B. BADESCH ◽  
MICHAEL D. McGOON ◽  
ROBIN J. BARST ◽  
VICTOR F. TAPSON ◽  
LEWIS J. RUBIN ◽  
...  
Keyword(s):  
Pulmonary Arterial Hypertension ◽  
Arterial Hypertension ◽  
Survival Rates ◽  
Randomized Controlled Study ◽  
Extension Study ◽  
Controlled Study ◽  
Open Label ◽  
Randomized Controlled ◽  
Pulmonary Arterial ◽  
Longterm Survival

Objective.Pulmonary arterial hypertension (PAH) remains challenging to treat, especially in association with scleroderma. We examined survival rates among patients with PAH in association with scleroderma who received epoprostenol (Flolan®) through continuous intravenous (IV) infusion in an uncontrolled open-label 3-year extension study following an initial randomized, controlled 12-week study.Methods.One hundred two patients diagnosed with PAH in association with scleroderma who received epoprostenol were included in the analyses. This included 51 PAH patients from a subject population of 56 who received epoprostenol in the randomized controlled study, and 46 patients from an initial population of 55 subjects on conventional therapy in the randomized controlled study, who received epoprostenol in the extension study. All patients in this extension study received open-label epoprostenol. Adverse events, survival, and dosing information were collected throughout the study.Results.The probabilities of survival during the first and second years for all subjects who received epoprostenol during the initial randomized controlled study or during the extension study were 0.71 and 0.52, respectively. This measure remained constant at 0.48 during the third and fourth years.Conclusion.This study reports longterm survival rates for patients with scleroderma-associated PAH treated with IV epoprostenol. Although comparisons to historical data should be made with caution, this study reports a better survival outcome than natural history data on patients with scleroderma-associated PAH.

Lung Ultrasound–Guided Dry Weight Assessment and Echocardiographic Measures in Hypertensive Hemodialysis Patients: A Randomized Controlled Study

2020 ◽  
Vol 75 (1) ◽  
pp. 11-20 ◽  
Author(s):  
Charalampos Loutradis ◽  
Christodoulos E. Papadopoulos ◽  
Vassilios Sachpekidis ◽  
Robert Ekart ◽  
Barbara Krunic ◽  
...  
Keyword(s):  
Lung Ultrasound ◽  
Dry Weight ◽  
Hemodialysis Patients ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Ultrasound Guided ◽  
Randomized Controlled

scholarly journals Auxora Versus Standard of Care For The Treatment of Severe or Critical COVID-19 Pneumonia: Results From A Randomized Controlled Trial

2020 ◽  
Author(s):  
Joseph Miller ◽  
Charles Bruen ◽  
Michael Schnaus ◽  
Jeffrey Zhang ◽  
Sadia Ali ◽  
...  
Keyword(s):  
Standard Of Care ◽  
Ordinal Scale ◽  
Controlled Study ◽  
Respiratory Complications ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Randomized Controlled ◽  
Crac Channel ◽  
The Impact

Abstract BACKGROUND: Calcium release-activated calcium (CRAC) channel inhibitors stabilize the pulmonary endothelium and block proinflammatory cytokine release, potentially mitigating respiratory complications observed in patients with COVID-19. This study aimed to investigate the safety and efficacy of Auxora, a novel, intravenously administered CRAC channel inhibitor, in adults with severe or critical COVID-19 pneumonia METHODS: A randomized, controlled, open-label study of Auxora was conducted in adults with severe or critical COVID-19 pneumonia. Patients were randomized 2:1 to receive three doses of once-daily Auxora versus standard of care (SOC) alone. The primary objective was to assess safety and tolerability of Auxora. Following FDA guidance, study enrollment was halted early to allow for transition to a randomized, blinded, placebo-controlled study. RESULTS: In total, 17 patients with severe and three with critical COVID-19 pneumonia were randomized to Auxora and nine with severe and one with critical COVID-19 pneumonia to SOC. Similar proportions of patients receiving Auxora and SOC experienced ≥1 adverse event (75% versus 80%, respectively). Fewer patients receiving Auxora experienced serious adverse events versus SOC (30% versus 50%, respectively). Two patients (10%) receiving Auxora and two (20%) receiving SOC died in the 30 days after randomization. Among patients with severe COVID-19 pneumonia, median time to recovery with Auxora was five days versus 12 days with SOC; recovery rate ratio was 1.87 (95%CI, 0.72, 4.89). Invasive mechanical ventilation was needed in 18% of patients with severe COVID-19 pneumonia receiving Auxora versus 50% receiving SOC (absolute risk reduction=32%; 95%CI, -0.07, 0.71). Outcomes measured by an 8-point ordinal scale were significantly improved for patients receiving Auxora, especially for patients with a baseline PaO2/FiO2=101-200. CONCLUSIONS: Auxora demonstrated a favorable safety profile in patients with severe or critical COVID-19 pneumonia and improved outcomes in patients with severe COVID-19 pneumonia. These results, however, are limited by the open-label study design and small patient population resulting from early cessation of enrollment in response to regulatory guidance. The impact of Auxora on respiratory complications in patients with severe COVID-19 pneumonia will be further assessed in a planned randomized, blinded, placebo-controlled study. Trial registration: ClinicalTrials.gov, NCT04345614. Submitted 7April2020 - https://clinicaltrials.gov/ct2/show/NCT04345614

scholarly journals Auxora Versus Standard of Care For The Treatment of Severe or Critical COVID-19 Pneumonia: Results From A Randomized Controlled Trial

2020 ◽  
Author(s):  
Joseph Miller ◽  
Charles Bruen ◽  
Michael Schnaus ◽  
Jeffrey Zhang ◽  
Sadia Ali ◽  
...  
Keyword(s):  
Standard Of Care ◽  
Ordinal Scale ◽  
Controlled Study ◽  
Respiratory Complications ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Randomized Controlled ◽  
Crac Channel ◽  
The Impact

Abstract BACKGROUND: Calcium release-activated calcium (CRAC) channel inhibitors stabilize the pulmonary endothelium and block proinflammatory cytokine release, potentially mitigating respiratory complications observed in patients with COVID-19. This study aimed to investigate the safety and efficacy of Auxora, a novel, intravenously administered CRAC channel inhibitor, in adults with severe or critical COVID-19 pneumonia METHODS: A randomized, controlled, open-label study of Auxora was conducted in adults with severe or critical COVID-19 pneumonia. Patients were randomized 2:1 to receive three doses of once-daily Auxora versus standard of care (SOC) alone. The primary objective was to assess safety and tolerability of Auxora. Following FDA guidance, study enrollment was halted early to allow for transition to a randomized, blinded, placebo-controlled study. RESULTS: In total, 17 patients with severe and three with critical COVID-19 pneumonia were randomized to Auxora and nine with severe and one with critical COVID-19 pneumonia to SOC. Similar proportions of patients receiving Auxora and SOC experienced ≥1 adverse event (75% versus 80%, respectively). Fewer patients receiving Auxora experienced serious adverse events versus SOC (30% versus 50%, respectively). Two patients (10%) receiving Auxora and two (20%) receiving SOC died in the 30 days after randomization. Among patients with severe COVID-19 pneumonia, median time to recovery with Auxora was five days versus 12 days with SOC; recovery rate ratio was 1.87 (95%CI, 0.72, 4.89). Invasive mechanical ventilation was needed in 18% of patients with severe COVID-19 pneumonia receiving Auxora versus 50% receiving SOC (absolute risk reduction=32%; 95%CI, -0.07, 0.71). Outcomes measured by an 8-point ordinal scale were significantly improved for patients receiving Auxora, especially for patients with a baseline PaO2/FiO2=101-200. CONCLUSIONS: Auxora demonstrated a favorable safety profile in patients with severe or critical COVID-19 pneumonia and improved outcomes in patients with severe COVID-19 pneumonia. These results, however, are limited by the open-label study design and small patient population resulting from early cessation of enrollment in response to regulatory guidance. The impact of Auxora on respiratory complications in patients with severe COVID-19 pneumonia will be further assessed in a planned randomized, blinded, placebo-controlled study. Trial registration: ClinicalTrials.gov, NCT04345614. Submitted 7April2020 - https://clinicaltrials.gov/ct2/show/NCT04345614

scholarly journals Auxora Versus Standard of Care For The Treatment of Severe or Critical COVID-19 Pneumonia: Results From A Randomized Controlled Trial

2020 ◽  
Author(s):  
Joseph Miller ◽  
Charles Bruen ◽  
Michael Schnaus ◽  
Jeffrey Zhang ◽  
Sadia Ali ◽  
...  
Keyword(s):  
Standard Of Care ◽  
Ordinal Scale ◽  
Controlled Study ◽  
Respiratory Complications ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Randomized Controlled ◽  
Crac Channel ◽  
The Impact

Abstract BACKGROUND: Calcium release-activated calcium (CRAC) channel inhibitors stabilize the pulmonary endothelium and block proinflammatory cytokine release, potentially mitigating respiratory complications observed in patients with COVID-19. This study aimed to investigate the safety and efficacy of Auxora, a novel, intravenously administered CRAC channel inhibitor, in adults with severe or critical COVID-19 pneumonia METHODS: A randomized, controlled, open-label study of Auxora was conducted in adults with severe or critical COVID-19 pneumonia. Patients were randomized 2:1 to receive three doses of once-daily Auxora versus standard of care (SOC) alone. The primary objective was to assess safety and tolerability of Auxora. Following FDA guidance, study enrollment was halted early to allow for transition to a randomized, blinded, placebo-controlled study. RESULTS: In total, 17 patients with severe and three with critical COVID-19 pneumonia were randomized to Auxora and nine with severe and one with critical COVID-19 pneumonia to SOC. Similar proportions of patients receiving Auxora and SOC experienced ≥1 adverse event (75% versus 80%, respectively). Fewer patients receiving Auxora experienced serious adverse events versus SOC (30% versus 50%, respectively). Two patients (10%) receiving Auxora and two (20%) receiving SOC died in the 30 days after randomization. Among patients with severe COVID-19 pneumonia, median time to recovery with Auxora was five days versus 12 days with SOC; recovery rate ratio was 1.87 (95%CI, 0.72, 4.89). Invasive mechanical ventilation was needed in 18% of patients with severe COVID-19 pneumonia receiving Auxora versus 50% receiving SOC (absolute risk reduction=32%; 95%CI, -0.07, 0.71). Outcomes measured by an 8-point ordinal scale were significantly improved for patients receiving Auxora, especially for patients with a baseline PaO2/FiO2=101-200. CONCLUSIONS: Auxora demonstrated a favorable safety profile in patients with severe or critical COVID-19 pneumonia and improved outcomes in patients with severe COVID-19 pneumonia. These results, however, are limited by the open-label study design and small patient population resulting from early cessation of enrollment in response to regulatory guidance. The impact of Auxora on respiratory complications in patients with severe COVID-19 pneumonia will be further assessed in a planned randomized, blinded, placebo-controlled study. Trial registration: ClinicalTrials.gov, NCT04345614. Submitted 7April2020 - https://clinicaltrials.gov/ct2/show/NCT04345614

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

Effect of dietary sodium restriction on body water, blood pressure, and inflammation in hemodialysis patients: a prospective randomized controlled study

2013 ◽  
Vol 46 (1) ◽  
pp. 91-97 ◽  
Author(s):  
Lidiane Silva Rodrigues Telini ◽  
Gabriela de Carvalho Beduschi ◽  
Jacqueline Costa Teixeira Caramori ◽  
João Henrique Castro ◽  
Luis Cuadrado Martin ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Hemodialysis Patients ◽  
Body Water ◽  
Dietary Sodium ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Sodium Restriction ◽  
Randomized Controlled ◽  
Dietary Sodium Restriction
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