RESUMEN
A prospective, randomized, controlled, multi-centre clinical trial was performed to test the effectiveness of an antimicrobial central venous catheter (CVC) made of polyurethane integrated with silver, platinum and carbon black (Vantex). Adults expected to require a CVC for more than 60 h were eligible, and were randomized to receive the test or control catheter. All CVCs were inserted with new venipunctures using full aseptic technique. Following catheter removal, the distal tip and an intracutaneous segment were removed and cultured using semiquantitative and quantitative methods. Peripheral blood samples were obtained and cultured to confirm cases of catheter-related bloodstream infection (CRBSI). Bacterial and fungal organisms were identified by standard microbiological methods. Catheter placement was performed primarily in the intensive care unit (50%) or operating theatre (42%). Complete data could be evaluated for 539 patients (77%). The mean duration of CVC placement was 149.3h (six days). There were no significant differences in colonization or bacteraemia rates between the test and control catheters. The overall colonization rate was not particularly low (24.5%), and yet CVC-related bacteraemia occurred in only 1.4% of patients, and CRBSI occurred in only one patient from the control group (0.2%). Insertion site and dressing change frequency were significantly associated with the colonization rate. Although CVCs with antimicrobial features have been associated with a decrease in catheter-related colonization and bacteraemia, this study demonstrated that infection rates may depend more on non-catheter-related factors, such as adherence to infection control standards, selection of insertion site, duration of CVC placement, and dressing change frequency. As microbial resistance increases, clinicians should make maximal use of these processes to reduce catheter-related infections.
Asunto(s)
Bacteriemia/prevención & control , Infecciones Bacterianas/prevención & control , Cateterismo Venoso Central/instrumentación , Catéteres de Permanencia/clasificación , Poliuretanos , Adulto , Bacteriemia/microbiología , Bacterias/crecimiento & desarrollo , Infecciones Bacterianas/microbiología , Cateterismo Venoso Central/efectos adversos , Catéteres de Permanencia/efectos adversos , Catéteres de Permanencia/microbiología , Contaminación de Equipos , Femenino , Humanos , MasculinoRESUMEN
RATIONALE AND OBJECTIVES: The objective of the two pivotal phase 3 studies was to evaluate the safety and efficacy of OptiMARK (Gd-DTPA-bis(methoxyethylamide) [Gd-DTPA-BMEA]) compared with Magnevist (Gd-DTPA) in magnetic resonance imaging of the central nervous system. METHODS: Two multicenter, randomized, double-blind, parallel group studies were conducted in 395 patients with known or suspected central nervous system pathology. Subjects were randomized to receive a single 0.1 mmol/kg intravenous injection of either Gd-DTPA-BMEA or Gd-DTPA. The safety of Gd-DTPA-BMEA and Gd-DTPA was monitored for up to 72 hours after study drug administration. Precontrast and postcontrast administration magnetic resonance scans were acquired using identical imaging planes and techniques. RESULTS: No deaths or unexpected adverse events were reported in either group. A comparison of adverse events by intensity and relation demonstrated no statistically significant differences between the two groups. Gd-DTPA-BMEA and Gd-DTPA were equivalent with respect to confidence in diagnosis, conspicuity, and border delineation. CONCLUSIONS: Gd-DTPA-BMEA and Gd-DTPA demonstrated comparable efficacy profiles, and the safety profiles were considered similar.
Asunto(s)
Enfermedades del Sistema Nervioso Central/patología , Medios de Contraste , Gadolinio DTPA , Compuestos Organometálicos , Adulto , Anciano , Encéfalo/patología , Medios de Contraste/efectos adversos , Método Doble Ciego , Femenino , Gadolinio , Gadolinio DTPA/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Compuestos Organometálicos/efectos adversos , Médula Espinal/patologíaRESUMEN
The purpose of this study was to evaluate the safety and efficacy of OptiMARK (gadoversetamide injection) compared with Magnevist (gadopentetate dimeglumine) in hepatic MRI of patients with suspected liver pathology. A Phase III, multicenter, randomized, double-blind, parallel group study was performed in adults with suspected liver pathology. All patients underwent contrast-enhanced computed tomography within 3 weeks prior to magnetic resonance scanning. Ninety-nine patients received OptiMARK, and 94 patients received Magnevist at a dose of 0.1 mmol/kg. Precontrast T1- and T2-weighted spin-echo imaging and T1-weighted gradient-echo imaging were performed, followed by T1-weighted gradient-echo imaging at 15-20 seconds, 1 minute, and 5 minutes after intravenous contrast injection. Three primary efficacy endpoints (confidence in lesion diagnosis, level of conspicuity, and lesion border delineation) were evaluated on the precontrast image set and compared with the pre plus postcontrast image set. Vital signs, physical examination, electrocardiograms (ECGs), and laboratory parameters (chemistry, hematology, and urinalysis) were measured at various time points. Adverse events were recorded. The study design and statistical analyses were chosen to demonstrate presumed equivalence of OptiMARK and Magnevist. There were no statistically significant differences in efficacy between OptiMARK and Magnevist as assessed by either blinded readers or the on-site principal investigators. No serious or unexpected adverse events were noted. Of the 193 patients receiving contrast media, 82 experienced a total of 154 adverse events. Thirty-three (21.4%) of these 154 adverse events were felt by the on-site investigators to be probably related to either study agent: 15 events in 9 patients in the OptiMARK group, and 18 events in 13 patients in the Magnevist group. Headache was the most common adverse event, occurring in 10.1% of the OptiMARK patients and 12.8% of the Magnevist patients. No clinically relevant trends were observed in any laboratory parameter or ECG findings in either treatment group. The results demonstrate the safety, efficacy, and equivalence of OptiMARK and Magnevist at a dose of 0.1 mmol/kg in hepatic magnetic resonance imaging of patients with suspected liver pathology.