scholarly journals Effect of Chahuang ointment on prevention of phlebitis from peripherally inserted central catheter: randomized clinical trial

2021 ◽  
Vol 55 ◽  
Author(s):  
Xian Wang ◽  
Xiang Lv ◽  
Jie Zhang ◽  
Yan Wang
Keyword(s):  
Controlled Trial ◽  
Color Doppler ◽  
Catheter Insertion ◽  
Control Group ◽  
Peripherally Inserted Central Catheter ◽  
Central Catheter ◽  
Color Doppler Flow Imaging ◽  
Effective Prevention ◽  
Tissue Edema ◽  
Multicenter Randomized Controlled Trial

ABSTRACT Objective: To assess the effect of Chahuang ointment, a Chinese herbal ointment, on the prevention of phlebitis in patients with peripherally inserted central catheters. Method: This was a multicenter randomized controlled trial, with 171 eligible patients randomly assigned into one of three groups: the Chahuang ointment group, the Mucopolysaccharide Polysulfate cream group, and the control group. The degrees of vein injuries at 72 hours after peripherally inserted central catheter insertion were the primary outcome. Secondary outcomes were the vascular wall thickness, tissue edema and microthrombus evaluated by Color Doppler Flow Imaging, the vascular endothelial growth factor, and endothelin-1 (ET-1) expression in vivo. Results: Compared with the control group, the Chahuang ointment group showed significantly lower incidence of postoperative phlebitis, tissue edema, and microthrombus at 72 hours after peripherally inserted central catheter insertion (all P<0.01). The VEGF and ET-1 expression were significantly inhibited in the Chahuang ointment group after 3 days of treatment (both P<0.01). There were no statistical differences in the degree of vein injuries, microthrombus, or tissue edema between the Chahuang ointment and mucopolysaccharide polysulfate groups (all P>0.05). Conclusion: Chahuang ointment was shown to provide effective prevention and protection against phlebitis after peripherally inserted central catheter insertion.

scholarly journals A comparison of hydrophobic polyurethane and polyurethane peripherally inserted central catheter: results from a feasibility randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Nicole C. Gavin ◽  
Tricia M. Kleidon ◽  
Emily Larsen ◽  
Catherine O’Brien ◽  
Amanda Ullman ◽  
...  
Keyword(s):  
Standard Care ◽  
Dwell Time ◽  
Controlled Trial ◽  
Intervention Group ◽  
Trial Registration ◽  
Care Group ◽  
Control Group ◽  
Peripherally Inserted Central Catheter ◽  
Central Catheter ◽  
Efficacy Trial

Abstract Background To evaluate the feasibility of an efficacy trial comparing a hydrophobic polyurethane peripherally inserted central catheter (PICC) with a standard polyurethane PICC. Methods This pilot randomised controlled trial (RCT) was conducted between May 2017 and February 2018. Adult participants (n = 111) were assigned to hydrophobic polyurethane PICC with proximal valve (intervention) or a polyurethane PICC with external clamp (standard care). Primary outcome was trial feasibility including PICC failure. Secondary outcomes were central line-associated bloodstream infection, local infection, occlusion, thrombosis, fracture and dislodgement, phlebitis, local or systemic allergic reaction, and PICC dwell time. Results All feasibility outcomes were achieved, apart from eligibility criteria. In total, 338 patients were screened, 138 were eligible (41%), and of these 111 were randomised (80%). Patients received the allocated PICC in 106 (95%) insertions. No patients withdrew from the study and there was no missing data. PICC failure was 24% (13/55) in the intervention group and 22% (12/55) in the standard care group (p = 0.820). PICC failure per 1000 PICC days was 16.3 in the intervention group and 18.4 in the control group (p = 0.755). The average dwell time was 12 days in the intervention and 8 days in the control group. Conclusions This study demonstrates the feasibility of an efficacy trial of PICC materials in an adult population, once adjustments were made to include not only in-patients, but also patients being discharged to the Hospital in the Home service. Trial registration Australia and New Zealand Clinical Trials Registry ACTRN12616001578493. Prospectively registered on 16 November 2016. The trial protocol was published a priori (Kleidon et al., Vasc Access 3:15–21, 2017).

Effect of tunneled and nontunneled peripherally inserted central catheter placement: A randomized controlled trial

2019 ◽  
Vol 21 (4) ◽  
pp. 511-519
Author(s):  
Can Dai ◽  
Jia Li ◽  
Qiu-mei Li ◽  
Xiuquan Guo ◽  
Yu-ying Fan ◽  
...  
Keyword(s):  
Lower Incidence ◽  
Controlled Trial ◽  
Prospective Trial ◽  
Catheter Placement ◽  
Control Group ◽  
Peripherally Inserted Central Catheter ◽  
Central Catheter ◽  
Randomized Controlled ◽  
Catheter Dislodgement ◽  
Experimental Group

Purpose: To compare the effect of tunneled and nontunneled peripherally inserted central catheter placement under B-mode ultrasound. Methods: A single center, randomized, controlled, nonblinded, prospective trial was conducted in Guangzhou, China, between July 2018 and May 2019. A total of 174 participants were randomized to the experimental group (tunneled peripherally inserted central catheter) or the control group (nontunneled peripherally inserted central catheter) and were followed until extubation. Basic characteristics, peripherally inserted central catheter characteristics, the incidence of complications, and the costs of peripherally inserted central catheter placement and maintenance were collected. Data were analyzed by intention-to-treat. Results: A total of 168 of the participants had successful peripherally inserted central catheter placements (85/87, 97.7% in the experimental group and 83/87, 95.4% in the control group, P = 0.682). Compared to the control group, the experimental group had a lower incidence of complications during the placement (18.4% vs 32.2%, P = 0.036), a lower incidence of wound oozing (27.6% vs 57.5%, P < 0.001), a lower incidence of medical adhesive–related skin injury (9.2% vs 25.3%, P = 0.005), a lower incidence of venous thrombosis (1.1% vs 9.2%, P = 0.034), a lower incidence of catheter dislodgement (1.1% vs 9.2%, P = 0.034), and lower costs of peripherally inserted central catheter maintenance at 1, 2, and 3 months ( P < 0.05). Conclusion: Tunneled peripherally inserted central catheter may be recommended for good effectiveness.

scholarly journals The impact of vildagliptin on the daily glucose profile and coronary plaque stability in impaired glucose tolerance patients with coronary artery disease: VOGUE—A multicenter randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hiroyuki Yamamoto ◽  
Akihide Konishi ◽  
Toshiro Shinke ◽  
Hiromasa Otake ◽  
Masaru Kuroda ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Fibrous Cap ◽  
Multicenter Randomized Controlled Trial ◽  
The Mean ◽  
Artery Disease ◽  
Fibrous Cap Thickness ◽  
The Impact

Abstract Background The impact of reduction in glycemic excursion on coronary plaques remains unknown. This study aimed to elucidate whether a dipeptidyl peptidase 4 inhibitor could reduce the glycemic excursion and stabilize the coronary plaques compared with conventional management in coronary artery disease (CAD) patients with impaired glucose tolerance (IGT). Methods This was a multicenter, randomized controlled trial including CAD patients with IGT under lipid-lowering therapy receiving either vildagliptin (50 mg once a day) or no medication (control group) regarding glycemic treatment. The primary endpoint was changes in the minimum fibrous cap thickness and lipid arc in non-significant native coronary plaques detected by optical coherence tomography at 6 months after intervention. Glycemic variability expressed as the mean amplitude of glycemic excursion (MAGE) measured with a continuous glucose monitoring system was evaluated before and 6 months after intervention. Results A total of 20 participants with 47 lesions were allocated to either the vildagliptin group (10 participants, 22 lesions) or the control group (10 participants, 25 lesions). The adjusted difference of mean changes between the groups was − 18.8 mg/dl (95% confidence interval, − 30.8 to − 6.8) (p = 0.0064) for the MAGE (vildagliptin, − 20.1 ± 18.0 mg/dl vs. control, 2.6 ± 12.7 mg/dl), − 22.8° (− 40.6° to − 5.1°) (p = 0.0012) for the mean lipid arc (vildagliptin, − 9.0° ± 25.5° vs. control, 15.8° ± 16.8°), and 42.7 μm (15.3 to 70.1 μm) (p = 0.0022) for the minimum fibrous cap thickness (vildagliptin, 35.7 ± 50.8 μm vs. control, − 15.1 ± 25.2 μm). Conclusions Vildagliptin could reduce the MAGE at 6 months and may be associated with the decreased lipid arc and increased minimum FCT of the coronary plaques in CAD patients with IGT as compared with the control group. These findings may represent its potential stabilization effect on coronary plaques, which are characteristic in this patient subset. Trial registration Registered in the UMIN clinical trial registry (UMIN000008620), Name of the registry: VOGUE trial, Date of registration: Aug 6, 2012, URL: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000010058

scholarly journals Guided meditation for vision acuity training on adolescent myopia: study protocol for an open-label, prospective, multicenter, randomized controlled trial

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Yibo Li ◽  
Lili Zhu ◽  
Raoying Wang ◽  
Xingyue Yang ◽  
Xinqi Jiang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Visual Acuity ◽  
Controlled Trial ◽  
Control Group ◽  
Health Maintenance ◽  
Ocular Symptoms ◽  
Thought Disorders ◽  
Multicenter Randomized Controlled Trial ◽  
Distant Visual Acuity

Abstract Background Currently, the population with myopia climbs steadily, and is developing toward younger age, posing a great concern to the health of adolescents. Myopia in severe cases can cause irreversible consequences such as glaucoma, blindness, and other complications. At present, the solutions for myopia are glasses, medication, and surgery. This study aims to investigate the role of a physiotherapy category based on guided meditation for vision acuity training on adolescent myopia. Methods This is a prospective, randomized, multicenter clinical trial. One thousand one hundred forty primary and secondary school students aged 8–18 years old from 27 schools will be recruited and randomly divided into an experimental and a control group at a ratio of 2:1 in two phases, with a training period of 30 days in each phase and a follow-up period of 3 months. No interventions will be conducted during the follow-up period, nor will other interventions employed. Inclusion criteria will meet the diagnostic criteria for simple myopia and −6.00D ≤ spherical lenses ≤ −0.50D and cylindrical lenses ≤1.50D. The primary observation index will be to compare the statistical differences in distant visual acuity between the two groups; the secondary observation indexes will be ocular symptoms (mainly including eye fatigue, dryness, pain, double vision, neck pain, thought disorders, and lags in response), diopter, and astigmatism. Discussion The purpose of this two-phase trial is to compare the clinical effectiveness of focused vision-guided meditation with Chinese eye exercises that are also non-pharmacological, non-invasive interventions for myopia, and to maximize the benefit to the subjects. The results will indicate whether the training based on focused vision-guided meditation has the ability to improve distant visual acuity, relieve ocular symptoms, and ameliorate diopter. In addition, this trial will provide clinical efficacy of the training, which is expected to provide meaningful data for vision rehabilitation. At the same time, the vision acuity training method, which is permeated with the concept of Traditional Chinese Medicine (TCM) rehabilitation and health maintenance, will be applied to achieve the goal of preventing or alleviating myopic development and reducing myopia rate. Trial registration Chinese Clinical Trial Registry ChiCTR2000038642. Registered on 26 September 2020

scholarly journals Guided Meditation For Vision Acuity Training On Adolescent Myopia: Study Protocol For A Prospective, Multicenter, Randomized Controlled Trial

2021 ◽  
Author(s):  
Yibo Li ◽  
Lili Zhu ◽  
Raoying Wang ◽  
Xinqi Jiang ◽  
Tao Lu
Keyword(s):  
Clinical Trial ◽  
Visual Acuity ◽  
Controlled Trial ◽  
Control Group ◽  
Health Maintenance ◽  
Ocular Symptoms ◽  
Thought Disorders ◽  
Multicenter Randomized Controlled Trial ◽  
Distant Visual Acuity

Abstract Background: Currently, the population with myopia climbs steadily, and developing toward younger age, posing a great concern to the health of adolescents. Myopia in severe cases can cause irreversible consequences such as glaucoma, blindness and other complications. At present, the solutions for myopia are glasses, medication and surgery. This study aims to investigate the role of a physiotherapy category based on guided meditation for vision acuity training on adolescent myopia. Methods: This is a prospective, randomized, multicenter clinical trial. 1140 primary and secondary school students aged 8-18 years old from 27 schools will be recruited and randomly divided into an experimental group and a control group at a ratio of 2:1 in two phases, with a training period of 30 days in each phase and a follow-up period of 3 months. No interventions will be conducted during the follow-up period, nor will other interventions employed. Inclusion criteria will meet the diagnostic criteria for simple myopia and -6.00D ≤ spherical lenses ≤ -0.50D, cylindrical lenses ≤ 1.50D. The primary observation index will be to compare the statistical differences in distant visual acuity between the two groups; the secondary observation indexes will be ocular symptoms (mainly including eye fatigue, dryness, pain, double vision, neck pain, thought disorders, and lags in response), diopter and astigmatism. Discussion: The purpose of this two-phase trial is to compare the clinical effectiveness of focused vision-guided meditation with Chinese eye exercises that are also non-pharmacological, non-invasive interventions for myopia, and to maximize the benefit to the subjects. The results will indicate whether the training based on focused vision-guided meditation has the ability to improve distant visual acuity, relieve ocular symptoms and ameliorate diopter. In addition, this trial will provide clinical efficacy of the training, which is expected to provide meaningful data for vision rehabilitation. At the same time, the vision acuity training method, which is permeated with the concept of Traditional Chinese Medicine (TCM) rehabilitation and health maintenance, will be applied to achieve the goal of preventing or alleviating myopic development and reducing myopia rate. Trial registration: Chinese Clinical Trial Registry (identifier: ChiCTR2000038642; Registered 26 September 2020, http://www.chictr.org.cn/showproj.aspx?proj=61729).

Abstract TP416: Effects Of Pioglitazone In Patients With Abnormal Glucose Metabolism After Stroke The J-SPIRIT Study

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Ryota Tanaka ◽  
Kazuo Yamashiro ◽  
Yasutaka Tanaka ◽  
Nobukazu Miyamoto ◽  
Yuji Ueno ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Ischemic Stroke ◽  
Glucose Metabolism ◽  
Recurrent Stroke ◽  
Controlled Trial ◽  
Control Group ◽  
Placebo Control ◽  
Newly Diagnosed ◽  
Abnormal Glucose Metabolism ◽  
Multicenter Randomized Controlled Trial

Background and aims: The stroke patients with abnormal glucose metabolism are increasing in Japan. The J-SPIRIT study (Juntendo the Stroke Prevention study in Insulin Resistance and Impaired glucose Tolerance) was planned to investigate the effect of pioglitazone on the reduction of recurrent stroke in the patients with abnormal glucose metabolism and insulin resistance after ischemic stroke. Methods: The study is a multicenter, randomized controlled trial performed in the four hospitals in Tokyo or neighboring cities in Japan. We enrolled the patients who ; (1) were 35 to 85 years old ; (2) had symptomatic ischemic stroke; (3) had no history of diabetes and no evidence of diabetes by initial blood test. Among those patients, a standard OGTT with 75g of glucose was performed at least 2 weeks after admission. We enrolled the patients of newly diagnosed diabetes and IGT by OGTT, and randomized these patients to receive either pioglitazone or matching placebo. Results: Total 134 patients were enrolled. 58 patients were received pioglitazone, 61 were placebo control. Mean HbA1c were not different among both groups (5.6±0.38 pioglitazone vs 5.5±0.38 control) and mean observation period were 25±19.9 months in piolgitazone group and 30±16 months in control group. The data showed a trend of benefit with pioglitazone for the primary end point of recurrence of ischemic stroke compared to placebo control. (event rate=3.4% pioglitazone vs 11.6% control) Conclusions: Our data indicated pioglitazone might be able reduce the risk of recurrent stroke in the patients of ischemic stroke with newly diagnosed abnormal glucose metabolism and insulin resistance.

Doxycycline Combined With Bortezomib-Cyclophosphamide-Dexamethasone Chemotherapy for Newly Diagnosed Cardiac Light-Chain Amyloidosis: A Multicenter Randomized Controlled Trial

Circulation ◽  
2021 ◽  
Author(s):  
Kai-ni Shen ◽  
Wei-jun Fu ◽  
Yu Wu ◽  
Yu-jun Dong ◽  
Zhong-xia Huang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Light Chain ◽  
Controlled Trial ◽  
Hazard Ratio ◽  
Stage Ii ◽  
Control Group ◽  
Al Amyloidosis ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Background: Doxycycline was demonstrated in a retrospective study to be associated with greater survival in patients with light chain (AL) amyloidosis. Therefore, we prospectively compared the efficacy of bortezomib-cyclophosphamide-dexamethasone (CyBorD) and CyBorD combined with doxycycline for cardiac AL amyloidosis. Methods: This was a multicenter, open-label randomized controlled trial. Patients with Mayo 2004 stage II-III AL amyloidosis were included. Patients were randomized to doxycycline 100 mg twice daily along with 9 cycles of CyBorD (doxycycline group) or to 9 cycles of CyBorD alone (control group). The primary outcome was 2-year progression-free survival (PFS). PFS was defined as the time from randomization to death, hematologic progression or organ progression (heart, kidney or liver). Hematologic progression was defined based on substantial increase in free light chain. Increase in either N-terminal pro B-type natriuretic peptide or cardiac troponin was the main criterion for defining cardiac progression. Cardiac PFS, defined as the time from randomization to cardiac progression or death, was compared between groups in an exploratory analysis. The corresponding treatment hazard ratio was estimated using a Cox regression model. Results: 140 patients underwent randomization, with 70 in each group. The median age was 61 (range, 33-78) years with a male: female ratio of 1.75:1. Stage II disease was present in 34 (48.6%) and 33 (47.1%) patients in the doxycycline and control groups, respectively. After a median follow-up duration of 24.4 months, 32/70 (45.7%) of patients in the doxycycline group and 30/70 (42.9%) of patients in the control group experienced progression. PFS was not significantly different between groups (hazard ratio 0.97, 95% CI, 0.59-1.60, p =0.91). Cardiac progression occurred in 29/70 (41.4%) of patients in the doxycycline group and 26/70 (37.1%) of patients in the control group. The death rates for both groups by the end of follow-up was the same, 25/70 (35.7%). There were no significant differences observed for either cardiac PFS (hazard ratio 0.91, 95% CI, 0.54-1.55, p =0.74) or overall survival (hazard ratio 1.04, 95% CI, 0.60-1.81, p =0.89). Conclusions: Our trial demonstrated that doxycycline combined with CyBorD failed to prolong PFS or cardiac PFS compared with CyBorD alone in cardiac AL amyloidosis. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT03401372.

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