Browsing by Author "Ruiz Balart, Carolina"

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    A randomized placebo-controlled phase II study of a Pseudomonas vaccine in ventilated ICU patients
    (2017) Rello, Jordi; Krenn, Claus-Georg; Locker, Gottfried; Pilger, Ernst; Madl, Christian; Balica, Laura; Dugernier, Thierry; Laterre, Pierre-Francois; Andresen Hernández, Max; Ruiz Balart, Carolina
    Abstract Background Currently, no vaccine against Pseudomonas is available. IC43 is a new, recombinant, protein (OprF/I)-based vaccine against the opportunistic pathogen, Pseudomonas aeruginosa, a major cause of serious hospital-acquired infections. IC43 has proven immunogenicity and tolerability in healthy volunteers, patients with burns, and patients with chronic lung diseases. In order to assess the immunogenicity and safety of IC43 in patients who are most at risk of acquiring Pseudomonas infections, it was evaluated in mechanically ventilated ICU patients. Methods We conducted a randomized, placebo-controlled, partially blinded study in mechanically ventilated ICU patients. The immunogenicity of IC43 at day 14 was determined as the primary endpoint, and safety, efficacy against P. aeruginosa infections, and all-cause mortality were evaluated as secondary endpoints. Vaccinations (100 μg or 200 μg IC43 with adjuvant, or 100 μg IC43 without adjuvant, or placebo) were given twice in a 7-day interval and patients were followed up for 90 days. Results Higher OprF/I IgG antibody titers were seen at day 14 for all IC43 groups versus placebo (P < 0.0001). Seroconversion (≥4-fold increase in OprF/I IgG titer from days 0 to 14) was highest with 100 μg IC43 without adjuvant (80.6%). There were no significant differences in P. aeruginosa infection rates, with a low rate of invasive infections (pneumonia or bacteremia) in the IC43 groups (11.2-14.0%). Serious adverse events (SAEs) considered possibly related to therapy were reported by 2 patients (1.9%) in the group of 100 µg IC43 with adjuvant. Both SAEs resolved and no deaths were related to study treatment. Local tolerability symptoms were mild and rare (<5% of patients), a low rate of treatment-related treatment-emergent adverse events (3.1–10.6%) was observed in the IC43 groups. Conclusion This phase II study has shown that IC43 vaccination of ventilated ICU patients produced a significant immunogenic effect. P. aeruginosa infection rates did not differ significantly between groups. In the absence of any difference in immune response following administration of 100 μg IC43 without adjuvant compared with 200 μg IC43 with adjuvant, the 100 μg dose without adjuvant was considered for further testing of its possible benefit of improved outcomes. There were no safety or mortality concerns. Trial registration ClinicalTrials.gov, NCT00876252 . Registered on 3 April 2009.Abstract Background Currently, no vaccine against Pseudomonas is available. IC43 is a new, recombinant, protein (OprF/I)-based vaccine against the opportunistic pathogen, Pseudomonas aeruginosa, a major cause of serious hospital-acquired infections. IC43 has proven immunogenicity and tolerability in healthy volunteers, patients with burns, and patients with chronic lung diseases. In order to assess the immunogenicity and safety of IC43 in patients who are most at risk of acquiring Pseudomonas infections, it was evaluated in mechanically ventilated ICU patients. Methods We conducted a randomized, placebo-controlled, partially blinded study in mechanically ventilated ICU patients. The immunogenicity of IC43 at day 14 was determined as the primary endpoint, and safety, efficacy against P. aeruginosa infections, and all-cause mortality were evaluated as secondary endpoints. Vaccinations (100 μg or 200 μg IC43 with adjuvant, or 100 μg IC43 without adjuvant, or placebo) were given twice in a 7-day interval and patients were followed up for 90 days. Results Higher OprF/I IgG antibody titers were seen at day 14 for all IC43 groups versus placebo (P < 0.0001). Seroconversion (≥4-fold increase in OprF/I IgG titer from days 0 to 14) was highest with 100 μg IC43 without adjuvant (80.6%). There were no significant differences in P. aeruginosa infection rates, with a low rate of invasive infections (pneumonia or bacteremia) in the IC43 groups (11.2-14.0%). Serious adverse events (SAEs) considered possibly related to therapy were reported by 2 patients (1.9%) in the group of 100 µg IC43 with adjuvant. Both SAEs resolved and no deaths were related to study treatment. Local tolerability symptoms were mild and rare (<5% of patients), a low rate of treatment-related treatment-emergent adverse events (3.1–10.6%) was observed in the IC43 groups. Conclusion This phase II study has shown that IC43 vaccination of ventilated ICU patients produced a significant immunogenic effect. P. aeruginosa infection rates did not differ significantly between groups. In the absence of any difference in immune response following administration of 100 μg IC43 without adjuvant compared with 200 μg IC43 with adjuvant, the 100 μg dose without adjuvant was considered for further testing of its possible benefit of improved outcomes. There were no safety or mortality concerns. Trial registration ClinicalTrials.gov, NCT00876252 . Registered on 3 April 2009.Abstract Background Currently, no vaccine against Pseudomonas is available. IC43 is a new, recombinant, protein (OprF/I)-based vaccine against the opportunistic pathogen, Pseudomonas aeruginosa, a major cause of serious hospital-acquired infections. IC43 has proven immunogenicity and tolerability in healthy volunteers, patients with burns, and patients with chronic lung diseases. In order to assess the immunogenicity and safety of IC43 in patients who are most at risk of acquiring Pseudomonas infections, it was evaluated in mechanically ventilated ICU patients. Methods We conducted a randomized, placebo-controlled, partially blinded study in mechanically ventilated ICU patients. The immunogenicity of IC43 at day 14 was determined as the primary endpoint, and safety, efficacy against P. aeruginosa infections, and all-cause mortality were evaluated as secondary endpoints. Vaccinations (100 μg or 200 μg IC43 with adjuvant, or 100 μg IC43 without adjuvant, or placebo) were given twice in a 7-day interval and patients were followed up for 90 days. Results Higher OprF/I IgG antibody titers were seen at day 14 for all IC43 groups versus placebo (P < 0.0001). Seroconversion (≥4-fold increase in OprF/I IgG titer from days 0 to 14) was highest with 100 μg IC43 without adjuvant (80.6%). There were no significant differences in P. aeruginosa infection rates, with a low rate of invasive infections (pneumonia or bacteremia) in the IC43 groups (11.2-14.0%). Serious adverse events (SAEs) considered possibly related to therapy were reported by 2 patients (1.9%) in the group of 100 µg IC43 with adjuvant. Both SAEs resolved and no deaths were related to study treatment. Local tolerability symptoms were mild and rare (<5% of patients), a low rate of treatment-related treatment-emergent adverse events (3.1–10.6%) was observed in the IC43 groups. Conclusion This phase II study has shown that IC43 vaccination of ventilated ICU patients produced a significant immunogenic effect. P. aeruginosa infection rates did not differ significantly between groups. In the absence of any difference in immune response following administration of 100 μg IC43 without adjuvant compared with 200 μg IC43 with adjuvant, the 100 μg dose without adjuvant was considered for further testing of its possible benefit of improved outcomes. There were no safety or mortality concerns. Trial registration ClinicalTrials.gov, NCT00876252 . Registered on 3 April 2009.Abstract Background Currently, no vaccine against Pseudomonas is available. IC43 is a new, recombinant, protein (OprF/I)-based vaccine against the opportunistic pathogen, Pseudomonas aeruginosa, a major cause of serious hospital-acquired infections. IC43 has proven immunogenicity and tolerability in healthy volunteers, patients with burns, and patients with chronic lung diseases. In order to assess the immunogenicity and safety of IC43 in patients who are most at risk of acquiring Pseudomonas infections, it was evaluated in mechanically ventilated ICU patients. Methods We conducted a randomized, placebo-controlled, partially blinded study in mechanically ventilated ICU patients. The immunogenicity of IC43 at day 14 was determined as the primary endpoint, and safety, efficacy against P. aeruginosa infections, and all-cause mortality were evaluated as secondary endpoints. Vaccinations (100 μg or 200 μg IC43 with adjuvant, or 100 μg IC43 without adjuvant, or placebo) were given twice in a 7-day interval and patients were followed up for 90 days. Results Higher OprF/I IgG antibody titers were seen at day 14 for all IC43 groups versus placebo (P < 0.0001). Seroconversion (≥4-fold increase in OprF/I IgG titer from days 0 to 14) was highest with 100 μg IC43 without adjuvant (80.6%). There were no significant differences in P. aeruginosa infection rates, with a low rate of invasive infections (pneumonia or bacteremia) in the IC43 groups (11.2-14.0%). Serious adverse events (SAEs) considered possibly related to therapy were reported by 2 patients (1.9%) in the group of 100 µg IC43 with adjuvant. Both SAEs resolved and no deaths were related to study treatment. Local tolerability symptoms were mild and rare (<5% of patients), a low rate of treatment-related treatment-emergent adverse events (3.1–10.6%) was observed in the IC43 groups. Conclusion This phase II study has shown that IC43 vaccination of ventilated ICU patients produced a significant immunogenic effect. P. aeruginosa infection rates did not differ significantly between groups. In the absence of any difference in immune response following administration of 100 μg IC43 without adjuvant compared with 200 μg IC43 with adjuvant, the 100 μg dose without adjuvant was considered for further testing of its possible benefit of improved outcomes. There were no safety or mortality concerns. Trial registration ClinicalTrials.gov, NCT00876252 . Registered on 3 April 2009.Abstract Background Currently, no vaccine against Pseudomonas is available. IC43 is a new, recombinant, protein (OprF/I)-based vaccine against the opportunistic pathogen, Pseudomonas aeruginosa, a major cause of serious hospital-acquired infections. IC43 has proven immunogenicity and tolerability in healthy volunteers, patients with burns, and patients with chronic lung diseases. In order to assess the immunogenicity and safety of IC43 in patients who are most at risk of acquiring Pseudomonas infections, it was evaluated in mechanically ventilated ICU patients. Methods We conducted a randomized, placebo-controlled, partially blinded study in mechanically ventilated ICU patients. The immunogenicity of IC43 at day 14 was determined as the primary endpoint, and safety, efficacy against P. aeruginosa infections, and all-cause mortality were evaluated as secondary endpoints. Vaccinations (100 μg or 200 μg IC43 with adjuvant, or 100 μg IC43 without adjuvant, or placebo) were given twice in a 7-day interval and patients were followed up for 90 days. Results Higher OprF/I IgG antibody titers were seen at day 14 for all IC43 groups versus placebo (P < 0.0001). Seroconversion (≥4-fold increase in OprF/I IgG titer from days 0 to 14) was highest with 100 μg IC43 without adjuvant (80.6%). There were no significant differences in P. aeruginosa infection rates, with a low rate of invasive infections (pneumonia or bacteremia) in the IC43 groups (11.2-14.0%). Serious adverse events (SAEs) considered possibly related to therapy were reported by 2 patients (1.9%) in the group of 100 µg IC43 with adjuvant. Both SAEs resolved and no deaths were related to study treatment. Local tolerability symptoms were mild and rare (<5% of patients), a low rate of treatment-related treatment-emergent adverse events (3.1–10.6%) was observed in the IC43 groups. Conclusion This phase II study has shown that IC43 vaccination of ventilated ICU patients produced a significant immunogenic effect. P. aeruginosa infection rates did not differ significantly between groups. In the absence of any difference in immune response following administration of 100 μg IC43 without adjuvant compared with 200 μg IC43 with adjuvant, the 100 μg dose without adjuvant was considered for further testing of its possible benefit of improved outcomes. There were no safety or mortality concerns. Trial registration ClinicalTrials.gov, NCT00876252 . Registered on 3 April 2009.Abstract Background Currently, no vaccine against Pseudomonas is available. IC43 is a new, recombinant, protein (OprF/I)-based vaccine against the opportunistic pathogen, Pseudomonas aeruginosa, a major cause of serious hospital-acquired infections. IC43 has proven immunogenicity and tolerability in healthy volunteers, patients with burns, and patients with chronic lung diseases. In order to assess the immunogenicity and safety of IC43 in patients who are most at risk of acquiring Pseudomonas infections, it was evaluated in mechanically ventilated ICU patients. Methods We conducted a randomized, placebo-controlled, partially blinded study in mechanically ventilated ICU patients. The immunogenicity of IC43 at day 14 was determined as the primary endpoint, and safety, efficacy against P. aeruginosa infections, and all-cause mortality were evaluated as secondary endpoints. Vaccinations (100 μg or 200 μg IC43 with adjuvant, or 100 μg IC43 without adjuvant, or placebo) were given twice in a 7-day interval and patients were followed up for 90 days. Results Higher OprF/I IgG antibody titers were seen at day 14 for all IC43 groups versus placebo (P < 0.0001). Seroconversion (≥4-fold increase in OprF/I IgG titer from days 0 to 14) was highest with 100 μg IC43 without adjuvant (80.6%). There were no significant differences in P. aeruginosa infection rates, with a low rate of invasive infections (pneumonia or bacteremia) in the IC43 groups (11.2-14.0%). Serious adverse events (SAEs) considered possibly related to therapy were reported by 2 patients (1.9%) in the group of 100 µg IC43 with adjuvant. Both SAEs resolved and no deaths were related to study treatment. Local tolerability symptoms were mild and rare (<5% of patients), a low rate of treatment-related treatment-emergent adverse events (3.1–10.6%) was observed in the IC43 groups. Conclusion This phase II study has shown that IC43 vaccination of ventilated ICU patients produced a significant immunogenic effect. P. aeruginosa infection rates did not differ significantly between groups. In the absence of any difference in immune response following administration of 100 μg IC43 without adjuvant compared with 200 μg IC43 with adjuvant, the 100 μg dose without adjuvant was considered for further testing of its possible benefit of improved outcomes. There were no safety or mortality concerns. Trial registration ClinicalTrials.gov, NCT00876252 . Registered on 3 April 2009.
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    Características de los pacientes traumatizados que ingresan a la UCI de un hospital general en Chile
    (2013) Ruiz Balart, Carolina; Mimica, Ximena; Lisbona, María Luisa; Donoso, Javiera; Arriagada, Paula; Roa, Macarena; Bravo Grau, Sebastián; Godoy, Jorge
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    Continuous prolonged prone positioning in COVID-19-related ARDS: a multicenter cohort study from Chile
    (2022) Cornejo, Rodrigo A.; Montoya, Jorge; Gajardo, Abraham I. J.; Graf, Jerónimo; Alegría Vargas, Leyla; Baghetti, Romyna; Irarrázaval, Anita; Santis, César; Pavez, Nicolás; Leighton, Sofía; Tomicic, Vinko; Morales, Daniel; Ruiz Balart, Carolina; Navarrete, Pablo; Vargas, Patricio; Gálvez, Roberto; Espinosa, Victoria; Lazo, Marioli; Pérez-Araos, Rodrigo A.; Garay, Osvaldo; Sepúlveda, Patrick; Martinez, Edgardo; Bruhn, Alejandro; The SOCHIMI Prone-COVID-19 Group; Pontificia Universidad Católica de Chile. Escuela de Medicina
    Background Prone positioning is currently applied in time-limited daily sessions up to 24 h which determines that most patients require several sessions. Although longer prone sessions have been reported, there is scarce evidence about the feasibility and safety of such approach. We analyzed feasibility and safety of a continuous prolonged prone positioning strategy implemented nationwide, in a large cohort of COVID-19 patients in Chile. Methods: Retrospective cohort study of mechanically ventilated COVID-19 patients with moderate-to-severe acute respiratory distress syndrome (ARDS), conducted in 15 Intensive Care Units, which adhered to a national protocol of continuous prone sessions  ≥ 48 h and until PaO2:FiO2 increased above 200 mm Hg. The number and extension of prone sessions were registered, along with relevant physiologic data and adverse events related to prone positioning. The cohort was stratified according to the first prone session duration: Group A, 2–3 days; Group B, 4–5 days; and Group C, > 5 days. Multivariable regression analyses were performed to assess whether the duration of prone sessions could impact safety. Results: We included 417 patients who required a first prone session of 4 (3–5) days of whom 318 (76.3%) received only one session. During the first prone session the main adverse event was grade 1–2 pressure sores in 97 (23.9%) patients; severe adverse events were infrequent with 17 non-scheduled extubations (4.2%). 90-day mortality was 36.2%. Ninety-eight patients (24%) were classified as group C; they exhibited a more severe ARDS at baseline, as reflected by lower PaO2:FiO2 ratio and higher ventilatory ratio, and had a higher rate of pressure sores (44%) and higher 90-day mortality (48%). However, after adjustment for severity and several relevant confounders, prone session duration was not associated with mortality or pressure sores. Conclusions: Nationwide implementation of a continuous prolonged prone positioning strategy for COVID-19 ARDS patients was feasible. Minor pressure sores were frequent but within the ranges previously described, while severe adverse events were infrequent. The duration of prone session did not have an adverse effect on safety.
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    Diseño de un dispositivo de aprendizaje en seguridad asistencial de pacientes críticos para el Programa de Residencia de Medicina Intensiva del Adulto de la Escuela de Medicina de la Pontificia Universidad Católica de Chile.
    (2019) Ruiz Balart, Carolina; Zúñiga Parada, Denisse Alejandra; Pontificia Universidad Católica de Chile. Escuela de Medicina
    Actualmente el desarrollo de la cultura de seguridad (SA) es uno de los desafíos más importantes para la atención sanitaria en el mundo, incluída la medicina intensiva (MI). La SA es una competencia que se puede aprender y entrenar, sin embargo, ha sido insuficientemente abordada en la formación de los médicos, tanto a nivel de pregrado como de postgrado. Ante esto, es fundamental que los educadores médicos se involucren activamente con esta necesidad educacional y problema asistencial. Pese a la relevancia de la SA es los pacientes críticos, esta no está considerada en el Programa de Residencia de MI de la Pontificia Universidad Católica de Chile (UC). La creación de una instancia formal de enseñanza-aprendizaje sobre SA dentro de este programa es una necesidad y busca responder a un problema de calidad y efectividad en salud. Ante esto, se desarrolló como actividad de graduación del Magister en Educación Médica de la UC una propuesta educativa de formación en SA para esta subespecialidad. El diseño de este dispositivo de aprendizaje se hizo de acuerdo a las seis etapas del modelo de Kern, teniendo en cuenta los principios de la andragogía y del aprendizaje experiencial. Se consideró el desarrollo gradual de los objetivos de aprendizaje, según el principio de formación progresiva desde novato a experto propuesto por CanMEDS. Es por esto, que el dispositivo se estructuró en dos partes. La primera parte corresponde a un taller de seguridad asistencial para residentes de medicina intensiva, que se implementará durante el primer año de residencia. Los objetivos de este taller están orientados a la adquisión y aplicación de conocimientos mediante metodologías activas de aprendizaje en pequeño grupo. La segunda parte, denominada aprendizaje de la seguridad asistencial en el ambiente clínico de la UCI (unidad de cuidados intensivos), se desarrollará en el segundo año de residencia durante una rotación clínica. Los objetivos de esta segunda parte hacen énfasis en los dominios actitudinales, dado lo relevante de una actitud positiva de los médicos para favorecer la cultura de la seguridad, así como, en la transferencia de los conocimientos adquiridos durante el taller al “hacer en el ambiente clínico”. Las metodologías a utilizar serán el aprendizaje en el lugar de trabajo, la práctica delibera, la práctica reflexiva y el modelaje.
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    La criticidad de las Unidades de Intensivo : ampliando las Unidades en tiempos de pandemia
    (2020) Andresen Hernández, Max; Born, P.; Kattan Tala, Eduardo José; Vera Alarcón, María Magdalena; Cataldo Cornejo, Alejandro; Ruiz Balart, Carolina; Bravo, S.
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    Medicina de urgencia y unidades de cuidados intensivos. Una alianza necesaria en busca de la mejoría de la atención de pacientes críticos
    (2016) Lara, Bárbara; Cataldo Cornejo, Alejandro; Castro López, Ricardo; Aguilera Fuenzalida, Pablo René; Ruiz Balart, Carolina; Andresen Hernández, Max
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    Mini-report : Microcirculatory flow abnormalities in a patient with severe hyperviscosity syndrome
    (2013) Ruiz Balart, Carolina; Hernández P., Glenn; Andresen Hernández, Max; Ince, C.; Bruhn, Alejandro
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    Reanimación con fluidos y hemoderivados en trauma
    (2014) Ruiz Balart, Carolina; Andresen Hernández, Max
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    Severe abnormalities in microvascular perfused vessel density are associated to organ dysfunctions and mortality and can be predicted by hyperlactatemia and norepinephrine requirements in septic shock patients
    (2013) Hernández P., Glenn; Boerma, C.; Dubin, A.; Bruhn, Alejandro; Koopmans, M.; Kanoore, V.; Ruiz Balart, Carolina; Castro López, Ricardo; Pozo M., Omar; Pedreros, C.; Veas, E.; Fuentealba, A.; Kattan Tala, Eduardo José; Rovegno Echavarria, Maxiliano