In Vitro and in Vivo Efficacy of a New Connector Device for Continuous Ambulatory Peritoneal Dialysis

1993 ◽  
Vol 13 (2_suppl) ◽  
pp. 148-151 ◽  
Author(s):  
Giusto Viglino ◽  
Adolfo Colombo ◽  
Paolo Cantu ◽  
Corrado Camerini ◽  
Luigi Catizone ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Controlled Trial ◽  
Test Group ◽  
Control Group ◽  
In Vivo Efficacy ◽  
Short Branch

The purpose of this study was to evaluate the In vltro and in vivo efficacy of a new connection system for continuous ambulatory peritoneal dialysis (CAPO), called the T-set. With this system the patient wears a 27–cm extension line filled with Amuchina during the dwell time; the bag is made of a fill container linked to a drainage tube with a Y-shaped set. For bag exchange, only one connection is needed and this is subsequently flushed with the entire drainage volume. The in vitro efficacy of the system was tested with 20 sets filled with 10 mL of Amuchina and inoculated in the distallumen with 2.1x103 colony-forming units (cfu) of S. aureus. After an Incubation of 4–6 hours at 35–37°C, three dialysate samples per set were collected, respectively, at the beginning of drainage and filling. Al1120 samples were negative, whereas two control sets, filled with a phosphate-buffered saline, had positive drainage samples, and at least one positive Infusion sample, Indicating the efficacy of Amuchina in sterilizing the system under conditions simulating touch contamination. To evaluate the in vivo efficacy, safety, and acceptability of the T-system, a prospective randomized controlled trial was performed In seven centers: a control group (CG) of 56 patients (follow-up: 952.3 months, mean±SO: 17.0±7.8) was treated with a long branch (21 patients) or short branch (35 patients) Y-set and a test group (TG) of 66 patients (follow-up: 898.1 months, mean±SO: 13.6±7.8) with the T-set. The two groups were comparable for patient and dialysis characteristics. The incidence of peritonitis was 1143.3 months in the CG and 1129.0 months In the TG (p=NS). The percentage of patients without peritonitis was 67.8% In the CG and 68.2% In the TG (p=NS); the probability of remaining free from peritonitis was, respectively, 76% and 75% In the CG and in the TG at 1 year, and 66% and 60% at 2 years (p=NS). In the CG 26 patients and In the TG 21 patients were already on CAPO before the trial; among these 21 patients, 10 of 10 with the long Y-set and 4 of 11 with the short Y-set who transferred to the T-set preferred the latter for better handling (52.4%) or for less encumbrance (14.3%).

Prospected Randomized Study of Two Y Devices in Continuous Ambulatory Peritoneal Dialysis (CAPD)

1989 ◽  
Vol 9 (3) ◽  
pp. 165-168 ◽  
Author(s):  
Giusto Viglino ◽  
Adolfo Colombo ◽  
Antonio Scalamogna ◽  
Pier L. Cavalli ◽  
Luisella Guerra ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Dwell Time ◽  
Randomized Study ◽  
Test Group ◽  
Control Group ◽  
Safety And Efficacy

To evaluate acceptability, safety, and efficacy of a y set with two short branches (TAs) filled with electrolytic chloroxidizer solution during the dwell time, 60 patients were randomly allocated to be treated with the traditional y set (TCs) or with the T AS. Twenty-three were new patients whereas the remaining 37 were patients already on continuous ambulatory peritoneal dialysis (CAPD) with the TCs. The follow-up was 416.5 months in the control group and 387.4 months in the test group. During the study period there were 6 peritonitis episodes in each group with an incidence of 1 episode every 69.4 patient-months in the control group and 1 episode every 64.6 patient-months in the test group. Twenty-four patients (80%) in the control group and 27 (90%) in the test group were free from peritonitis. The probability to remain free from peritonitis was respectively 87% and 83% in the test group and in control group after 12 months, 70% and 78% after 21 months. seventy -nine percent of the patients who used both systems preferred the T AS for better handling, lower encumbrance, and major safety. One patient preferred the TCs, three patients did not find any differences between the two devices.

Failure of Demonstrated Clinical Efficacy of Antibiotic-Bonded Continuous Ambulatory Peritoneal Dialysis (CAPD) Catheters

1990 ◽  
Vol 10 (1) ◽  
pp. 57-59 ◽  
Author(s):  
Stanley Z. Trooskin ◽  
Richard A. Harvey ◽  
T. w. J. Lennard ◽  
Ralph S. Greco
Keyword(s):  
Clinical Trial ◽  
Peritoneal Dialysis ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Infectious Complications ◽  
Clinical Report ◽  
Age And Gender ◽  
And Gender ◽  
To Receive

Previous in vitro, in vivo, and a preliminary clinical report have demonstrated efficacy of noncovalently bonding antibiotics to the surface of continuous ambulatory peritoneal dialysis (CAPO) catheters in decreasing infectious complications. A larger prospective randomized clinical trial was completed. Eighty-six patients with chronic renal failure were enrolled in the study and randomized to receive either a surfactant treated or untreated control catheter. All catheters were soaked in cefoxitin at the time of insertion. Groups were comparable in terms of pre-existing illnesses, age, and gender. No differences were shown in the incidence of cathetertract infections, peritonitis or mechanical complications. There was also no differences in microbiologic culture results. Therefore, it is concluded that this clinical trial did not demonstrate a reduction in catheter-related infectious complications by antibiotic bonding.

scholarly journals Protocol for a randomised, open-label, parallel group, multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dialysis

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e024589
Author(s):  
Wen Yao Mak ◽  
Loke Meng Ong ◽  
Bak Leong Goh ◽  
Sunita Bavanandan ◽  
Lily Mushahar ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Randomised Controlled Trial ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Open Label ◽  
Randomised Controlled ◽  
End Stage

IntroductionPeritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making.Methods and analysisThe study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.Ethics and disseminationThe study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.Trial registration numberNCT03177031; Pre-results.

scholarly journals Effectiveness of a smartphone-based, augmented reality exposure app to reduce fear of spiders in real-life: a randomized controlled trial

2021 ◽  
Author(s):  
Anja Zimmer ◽  
Nan Wang ◽  
Merle Ibach ◽  
Bernhard Fehlmann ◽  
Nathalie Schicktanz ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Augmented Reality ◽  
Controlled Trial ◽  
Intervention Group ◽  
Real Life ◽  
Control Group ◽  
Randomized Controlled ◽  
Distress Scale

Although in vivo exposure therapy is highly effective in the treatment of specific phobias, only a minority of patients seeks therapy. Exposure to virtual objects has been shown to be better tolerated, equally efficacious, but the technology has not been made widely accessible yet. We developed an augmented reality (AR) application (app) to reduce fear of spiders and performed a randomized controlled trial comparing the effects of our app (six 30-min sessions at home over a two-week period) with no intervention. Primary outcome was subjective fear, measured by a Subjective Units of Distress Scale (SUDS) in a Behavioural Approach Test (BAT) in a real-life spider situation at six weeks follow-up. Between Oct 7, 2019, and Dec 6, 2019, 66 individuals were enrolled and randomized. The intervention led to significantly lower subjective fear in the BAT compared to the control group (intervention group, baseline: 7·12 [SD 2·03] follow-up: 5·03 [SD 2·19] vs. control group, baseline: 7·06 [SD 2·34], follow-up 6·24 [SD 2.21]; adjusted group difference -1·24, 95% CI -2·17 to -0·31; Cohen’s d=0·57, p=0·01). The repeated use of the AR app reduces subjective fear in a real-life spider situation, providing a low-threshold and low-cost treatment for fear of spiders.

scholarly journals Efficacy of nano-carbonate apatite dentifrice in relief from dentin hypersensitivity following non-surgical periodontal therapy: A randomized controlled trial

2019 ◽  
Author(s):  
Pei-Hui Ding ◽  
Anna Dai ◽  
Hua-Jiao Hu ◽  
Jia-Ping Huang ◽  
Jia-Mei Liu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Test Group ◽  
Periodontal Therapy ◽  
Control Group ◽  
Carbonate Apatite ◽  
Dentine Hypersensitivity ◽  
Randomized Controlled ◽  
At Home

Abstract Background: Dentine hypersensitivity (DH) could occur or intensify after non-surgical periodontal therapy because of the exposure of dentine tubules. It has been demonstrated that nano-sized particles could seal these the dentine tubules. This randomized controlled trial aimed to investigate the efficacy of dentifrice containing nano-carbonate apatite (n-CAP) in reducing dentine hypersensitivity (DH) after non-surgical periodontal therapy. Methods: 48 periodontitis patients with DH were included in this clinical trial. After non-surgical periodontal therapy, patients included were randomized to test and control group and the respective dentifrices were applied at chairside, after which they were instructed to brush teeth with the allocated dentifrices twice a day at home. Periodontal parameters were recorded at baseline and the last follow-up. DH was measured by air-blast test and recorded by visual analogue scale (VAS) and Schiff sensitivity scale at baseline, after polishing (0 week) and 2/4/6 weeks. Results: 45 participants completed the follow-up. Periodontal parameters were improved and comparable between groups. Significant reduction in DH was observed in both groups at all time-points compared to baseline in terms of VAS and Schiff score. The test group achieved significantly greater relief from hypersensitivity compared with the control group after 4-week at-home use (for VAS, test group: 0.66 ± 0.68 versus control group: 0.84 ± 0.78, p = 0.005; for Schiff score, test group: 0.69 ± 0.71 versus control group: 0.97 ± 0.77, p < 0.001). Conclusions: Home-use of n-CAP based dentifrice provided a significantly better alleviation of DH following non-surgical periodontal therapy after 4 weeks compared to the control product. Trail registration: Chinese Clinical Trials Registry (No. ChiCTR-IPR-17011678, http://www.chictr.org.cn/, registered 16 June, 2017)

scholarly journals Biotherapic of Trypanosoma cruzi 17d increases apoptosis in experimentally infected mice

2021 ◽  
Vol 10 (36) ◽  
pp. 119-124
Author(s):  
Patrícia Flora Sandri ◽  
Gislaine Janaina Sanchez Falkowski ◽  
Luzmarina Hernandes ◽  
Márcia Machado de Oliveira Dalálio ◽  
Denise Lessa Aleixo ◽  
...  
Keyword(s):  
Trypanosoma Cruzi ◽  
Controlled Trial ◽  
Basic Research ◽  
Treated Group ◽  
Oral Route ◽  
Control Group ◽  
Phagocytic Cells ◽  
Number Of Cells

Introduction: the mechanism of action of ultradiluted medicines has not yet been established[1,3]. Many basic research studies have focused on isopathic models using in vitro or in vivo designs [4,5]. Recent studies indicate that an ultradiluted (isopathic) antigen can transfer signals to the immune system and modulate its response when an organism is challenged against this same antigen [6]. Some studies on experimental infection of mice by T. cruzi identified apoptotic cells and showed that the increase of their number is associated with an increase also in the number of parasites in the blood of the infected animals, while blockage of apoptosis can be the target of therapeutic intervention [7,8]. Aim: to evaluate the development of apoptosis in mice treated with biotherapic of Trypanosoma cruzi in dilution 17d through in situ detection of fragmented DNA. Method: in a blind randomized controlled trial, 36 male Swiss mice age 4 or 8 weeks were distributed in groups control - treated with 7% hydroalcoholic solution(CI-4=9 animals or CI-8=9 animals); and treated with biotherapic 17d (BIOT-4=9 animals or BIOT-8=9 animals). Infection was performed with 1,400 trypomastigotes T. cruzi-strain Y via intraperitoneal. Biotherapic 17d was prepared through the addition of 0.9ml of concentrated T. cruzi (10E+7 trypomastigotes/ml) to 9.1 ml of distilled water. The following dilutions were prepared in 86% hydroalcoholic solution until dilution 16d. Dilution 17d was prepared with 7% hydroalcoholic solution. It was performed microbiological control and biological risk in vivo. Treatment: 0.2 ml in 3 consecutive days, oral route, from the moment infection was verified. Animals were sacrificed on the 3rd day of treatment in a chamber saturated with ether. The liver and spleen were removed and fixated in 4% paraformaldehyde for 24 hours and then included in paraffin. Apoptosis was evaluated through DNA fragmentation – TUNEL technique (TdT dUTP-biotin Nick End Labeling (ApopTag® Peroxidade-Chemicon). For statistical analysis software Statistica 8.0 was used. This study was approved by the Ethics Committee for Animal Experimentation of UEM. Results and Discussion: in the samples of liver of animals age 4 and 8 weeks either treated or not with biotherapic 17d it was found cells parasitized by amastigotes of T. cruzi with apoptotic bodies, or phagocytic cells with phagocytic vacuole with apoptotic marked material inside them. The number of cells in apoptosis in animals age 4 weeks was not significantly (p=0.03) larger in treated group BIOT-C4 than in control group CI-4 (Figure 1). In animals age 8 weeks, the number of cells in apoptosis was significantly (p

scholarly journals Microbiological and SEM-EDS Evaluation of Titanium Surfaces Exposed to Periodontal Gel: In Vitro Study

Materials ◽  
2019 ◽  
Vol 12 (9) ◽  
pp. 1448 ◽  
Author(s):  
Sara Bernardi ◽  
Serena Bianchi ◽  
Anna Rita Tomei ◽  
Maria Adelaide Continenza ◽  
Guido Macchiarelli
Keyword(s):  
Inflammatory Diseases ◽  
Test Group ◽  
In Vitro Study ◽  
Positive Control ◽  
Control Group ◽  
Anaerobic Conditions ◽  
Titanium Surfaces ◽  
Implant Dentistry

Inflammatory diseases affecting the soft and hard tissues surrounding an implant represent a new challenge in contemporary implant dentistry. Among several methods proposed for the decontamination of titanium surfaces, the administration of topical 14% doxycycline gel seems to be a reliable option. In the present study, we evaluated the microbial effect of 14% doxycycline gel applied on titanium surfaces and exposed to human salivary microbes in anaerobic conditions. We also examined the composition of the exposed surfaces to assess the safe use of periodontal gel on titanium surfaces. Six anatase and six type 5 alloy titanium surfaces were used and divided into two groups: The test group and the positive control group. Both were cultured with human salivary samples in anaerobic conditions. On the test groups, 240 mg of periodontal gel was applied. The microbial assessment was performed with a colony-forming unit (CFU) count and matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) to identify the species. The surface integrity was assessed using scanning electron microscopy-energy dispersive X-ray spectrometry (SEM-EDS). The results demonstrated the microbial efficacy of the 14% doxycycline periodontal gel and its safe use on titanium surfaces. However, the SEM observations revealed the permanence of the gel on the titanium surfaces due to the physical composition of the gel. This permanence needs to be further investigated in vivo and a final polishing protocol on the titanium surface is recommended.

scholarly journals Tapered, Double-Lead Threads Single Implants Placed in Fresh Extraction Sockets and Healed Sites of the Posterior Jaws: A Multicenter Randomized Controlled Trial with 1 to 3 Years of Follow-Up

2017 ◽  
Vol 2017 ◽  
pp. 1-16 ◽  
Author(s):  
Alessandro Cucchi ◽  
Elisabetta Vignudelli ◽  
Simonetta Franco ◽  
Luca Levrini ◽  
Dario Castellani ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Survival Rates ◽  
Test Group ◽  
Primary Stability ◽  
Control Group ◽  
Complication Rates ◽  
Significant Difference ◽  
Multicenter Randomized Controlled Trial ◽  
Implant Crown

Purpose. To evaluate the survival, success, and complication rates of tapered double-lead threads single implants, placed in fresh extraction sockets and healed sites of the posterior jaws. Methods. The enrolled patients were randomly divided into 2 groups: in the test group (TG), all implants were inserted at the time of tooth extraction; in the control group (CG), all implants were placed 3 months after extraction. The implants were followed for a period of 1 to 3 years after loading. The main outcomes were implant survival, complications, and implant-crown success. Results. Ninety-two patients had 97 installed implants (49 in the TG, 48 in the CG). Only two implants failed, in the TG; the survival rates were therefore 95.9% (47/49) and 100% (48/48) for TG and CG, respectively. In the surviving implants, no complications were reported, for an implant-crown success of 100%. Conclusions. Although a significant difference was found in the levels of primary stability between TG and CG, single implants placed in fresh extraction sockets and healed sites of the posterior jaws had similar survival and complication rates. Crestal bone levels and peri-implant bone resorption showed similar values. A longer follow-up period is however required, to confirm these positive outcomes.

Nutritional Status of Capd Patients at Three Years

1996 ◽  
Vol 16 (1_suppl) ◽  
pp. 195-204 ◽  
Author(s):  
Leocadia Palop ◽  
Nicanor Vega ◽  
Teresa Rodriguez ◽  
Ana Fernandez ◽  
Jose C. Rodriguez ◽  
...  
Keyword(s):  
Renal Function ◽  
Peritoneal Dialysis ◽  
Steady State ◽  
Nutritional Status ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Nutritional Assessment ◽  
Residual Renal Function ◽  
Control Group ◽  
Protein Calorie Malnutrition

A nutritional assessment was carried out in 63 patients starting treatment from April 1990 up to December 1993. Anthropometric measurements were performed showing a prevalence of protein-calorie malnutrition (PCM) of 21 % in a total of 142 clinical surveys carried out in the above-mentioned sample. A steady state of albumin levels in plasma was verified during a three-year follow-up period at a lower level than that of the control group. The patients’ lymphocytic profile throughout the study was characterized by lymphopenia and decreased B and T 8 lymphocytes. During the first two years of continuous ambulatory peritoneal dialysis (CAPD), a high percentage of patients met the “adequacy” dialysis criteria as residual renal function plays an important role as regards treatment.

scholarly journals Efficacy of nano-carbonate apatite dentifrice in relief from dentin hypersensitivity following non-surgical periodontal therapy: A randomized controlled trial

2020 ◽  
Author(s):  
Pei-Hui Ding ◽  
Anna Dai ◽  
Hua-Jiao Hu ◽  
Jia-Ping Huang ◽  
Jia-Mei Liu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Test Group ◽  
Periodontal Therapy ◽  
Control Group ◽  
Dentin Hypersensitivity ◽  
Carbonate Apatite ◽  
Dentine Hypersensitivity ◽  
Randomized Controlled

Abstract Background: Dentine hypersensitivity (DH) could occur or intensify after non-surgical periodontal therapy because of the exposure of dentine tubules, but currently no gold standard exists to treat DH. It has been demonstrated that nano-sized particles presented potential for dentine tubules blocking and remineralization. This randomized controlled trial aimed to investigate the efficacy of dentifrice containing nano-carbonate apatite (n-CAP) in reducing dentine hypersensitivity (DH) after non-surgical periodontal therapy. Methods: 48 periodontitis patients with DH were included in this clinical trial. After non-surgical periodontal therapy, patients included were randomized to test and control group and the respective dentifrices were applied at chairside, after which they were instructed to brush teeth with the allocated dentifrices twice a day at home. Periodontal parameters were recorded at baseline and the last follow-up. DH was measured by air-blast test and recorded by visual analogue scale (VAS) and Schiff sensitivity scale at baseline, after polishing (0 week) and 2/4/6 weeks. Results: 45 participants completed the follow-up. Periodontal parameters were improved and comparable between groups. Significant reduction in DH was observed in both groups at all time-points compared to baseline in terms of VAS and Schiff score. The test group achieved significantly greater relief from hypersensitivity compared with the control group after 4-week at-home use (for change of VAS, test group: 2.27 ± 2.47 versus control group: 1.68 ± 2.24, p = 0.036; for change of Schiff, test group: 0.94 ± 0.92 versus control group: 0.61 ± 0.83, p < 0.001). The 6-week results showed borderline significance between groups in terms of change of Schiff (p = 0.027) and no significance in terms of change of VAS (p = 0.256). Conclusions: Home-use of n-CAP based dentifrice had some benefit on alleviation of DH following non-surgical periodontal therapy after 4 weeks compared to the control product. Trial registration: Chinese Clinical Trials Registry (No. ChiCTR-IPR-17011678, http://www.chictr.org.cn/, registered 16 June, 2017) Keywords: dentin hypersensitivity; dentifrices; randomized controlled trial; periodontitis

Sign in / Sign up

Export Citation Format

Share Document