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You searched for:"Renato Hideo Nakagawa Santos"
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, , , Abstract
Critical Care Science. 2024;36:e20240053en
DOI 10.62675/2965-2774.20240053-en
, , , , , , , , , , , , , Critically ill patients are at increased risk of health care-associated infections due to various devices (central line-associated bloodstream infection, catheter-associated urinary tract infection, and ventilator-associated pneumonia), which pose a significant threat to this population. Among several strategies, daily bathing with chlorhexidine digluconate, a water-soluble antiseptic, has been studied as an intervention to decrease the incidence of health care-associated infections in the intensive care unit; however, its ability to reduce all health care-associated infections due to various devices is unclear. We designed the Daily Chlorhexidine Bath for Health Care Associated Infection Prevention (CLEAN-IT) trial to assess whether daily chlorhexidine digluconate bathing reduces the incidence of health care-associated infections in critically ill patients compared with soap and water bathing.
The CLEAN-IT trial is a multicenter, open-label, cluster randomized crossover clinical trial. All adult patients admitted to the participating intensive care units will be included in the trial. Each cluster (intensive care unit) will be randomized to perform either initial chlorhexidine digluconate bathing or soap and water bathing with crossover for a period of 3 to 6 months, depending on the time of each center’s entrance to the study, with a 1-month washout period between chlorhexidine digluconate bathing and soap and water bathing transitions. The primary outcome is the incidence of health care-associated infections due to devices. The secondary outcomes are the incidence of each specific health care-associated infection, rates of microbiological cultures positive for multidrug-resistant pathogens, antibiotic use, intensive care unit and hospital length of stay, and intensive care unit and hospital mortality.
The CLEAN-IT trial will be used to study feasible and affordable interventions that might reduce the health care-associated infection burden in critically ill patients.
Abstract
Critical Care Science. 2024;36:e20240053en
DOI 10.62675/2965-2774.20240053-en
, , , , , , , , , , , , , Critically ill patients are at increased risk of health care-associated infections due to various devices (central line-associated bloodstream infection, catheter-associated urinary tract infection, and ventilator-associated pneumonia), which pose a significant threat to this population. Among several strategies, daily bathing with chlorhexidine digluconate, a water-soluble antiseptic, has been studied as an intervention to decrease the incidence of health care-associated infections in the intensive care unit; however, its ability to reduce all health care-associated infections due to various devices is unclear. We designed the Daily Chlorhexidine Bath for Health Care Associated Infection Prevention (CLEAN-IT) trial to assess whether daily chlorhexidine digluconate bathing reduces the incidence of health care-associated infections in critically ill patients compared with soap and water bathing.
The CLEAN-IT trial is a multicenter, open-label, cluster randomized crossover clinical trial. All adult patients admitted to the participating intensive care units will be included in the trial. Each cluster (intensive care unit) will be randomized to perform either initial chlorhexidine digluconate bathing or soap and water bathing with crossover for a period of 3 to 6 months, depending on the time of each center’s entrance to the study, with a 1-month washout period between chlorhexidine digluconate bathing and soap and water bathing transitions. The primary outcome is the incidence of health care-associated infections due to devices. The secondary outcomes are the incidence of each specific health care-associated infection, rates of microbiological cultures positive for multidrug-resistant pathogens, antibiotic use, intensive care unit and hospital length of stay, and intensive care unit and hospital mortality.
The CLEAN-IT trial will be used to study feasible and affordable interventions that might reduce the health care-associated infection burden in critically ill patients.
, , , , , Abstract
Revista Brasileira de Terapia Intensiva. 2022;34(1):44-55
DOI 10.5935/0103-507X.20220002-en
, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , Repurposed drugs are important in resource-limited settings because the interventions are more rapidly available, have already been tested safely in other populations and are inexpensive. Repurposed drugs are an effective solution, especially for emerging diseases such as COVID-19. The REVOLUTIOn trial has the objective of evaluating three repurposed antiviral drugs, atazanavir, daclatasvir and sofosbuvir, already used for HIV- and hepatitis C virus-infected patients in a randomized, placebo-controlled, adaptive, multiarm, multistage study. The drugs will be tested simultaneously in a Phase II trial to first identify whether any of these drugs alone or in combination reduce the viral load. If they do, a Phase III trial will be initiated to investigate if these medications are capable of increasing the number of days free respiratory support. Participants must be hospitalized adults aged ≥ 18 years with initiation of symptoms ≤ 9 days and SpO2 ≤ 94% in room air or a need for supplemental oxygen to maintain an SpO2 > 94%. The expected total sample size ranges from 252 to 1,005 participants, depending on the number of stages that will be completed in the study. Hence, the protocol is described here in detail together with the statistical analysis plan. In conclusion, the REVOLUTIOn trial is designed to provide evidence on whether atazanavir, daclatasvir or sofosbuvir decrease the SARS-CoV-2 load in patients with COVID-19 and increase the number of days patients are free of respiratory support. In this protocol paper, we describe the rationale, design, and status of the trial.
ClinicalTrials.gov identifier:
Abstract
Revista Brasileira de Terapia Intensiva. 2022;34(1):44-55
DOI 10.5935/0103-507X.20220002-en
, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , Repurposed drugs are important in resource-limited settings because the interventions are more rapidly available, have already been tested safely in other populations and are inexpensive. Repurposed drugs are an effective solution, especially for emerging diseases such as COVID-19. The REVOLUTIOn trial has the objective of evaluating three repurposed antiviral drugs, atazanavir, daclatasvir and sofosbuvir, already used for HIV- and hepatitis C virus-infected patients in a randomized, placebo-controlled, adaptive, multiarm, multistage study. The drugs will be tested simultaneously in a Phase II trial to first identify whether any of these drugs alone or in combination reduce the viral load. If they do, a Phase III trial will be initiated to investigate if these medications are capable of increasing the number of days free respiratory support. Participants must be hospitalized adults aged ≥ 18 years with initiation of symptoms ≤ 9 days and SpO2 ≤ 94% in room air or a need for supplemental oxygen to maintain an SpO2 > 94%. The expected total sample size ranges from 252 to 1,005 participants, depending on the number of stages that will be completed in the study. Hence, the protocol is described here in detail together with the statistical analysis plan. In conclusion, the REVOLUTIOn trial is designed to provide evidence on whether atazanavir, daclatasvir or sofosbuvir decrease the SARS-CoV-2 load in patients with COVID-19 and increase the number of days patients are free of respiratory support. In this protocol paper, we describe the rationale, design, and status of the trial.
ClinicalTrials.gov identifier:
Abstract
Revista Brasileira de Terapia Intensiva. 2018;30(3):264-285
DOI 10.5935/0103-507X.20180058
To investigate the existing capacity for renal replacement therapy and site-specific practices for managing acute kidney injury at centers participating in the BaSICS trial.
A questionnaire was provided to the chairs of 61 intensive care units enrolled in a randomized clinical trial in Brazil. A total of 124 physicians completed the questionnaire.
Approximately 15% of the patients admitted to the analyzed intensive care units received renal replacement therapy at the time of data collection. At least one renal replacement method was available in all of the analyzed units. Continuous methods were available more frequently at the private units than at the public units. The time from indication to onset of treatment was longer at the public units than at private units. The main obstacles to treatment initiation at public intensive care units were related to the availability of equipment and personnel, while the main bottleneck at private units was the nephrologist assessment. A considerable proportion of the participants stated that they would change their approach to renal replacement therapy if there were no limitations on the availability of methods in their units.
There was wide variation in the availability of resources for renal replacement therapy and in the management of acute kidney injury in Brazilian intensive care units. This information should be taken into account when planning clinical trials focused on this topic in Brazil.
Abstract
Revista Brasileira de Terapia Intensiva. 2018;30(3):264-285
DOI 10.5935/0103-507X.20180058
To investigate the existing capacity for renal replacement therapy and site-specific practices for managing acute kidney injury at centers participating in the BaSICS trial.
A questionnaire was provided to the chairs of 61 intensive care units enrolled in a randomized clinical trial in Brazil. A total of 124 physicians completed the questionnaire.
Approximately 15% of the patients admitted to the analyzed intensive care units received renal replacement therapy at the time of data collection. At least one renal replacement method was available in all of the analyzed units. Continuous methods were available more frequently at the private units than at the public units. The time from indication to onset of treatment was longer at the public units than at private units. The main obstacles to treatment initiation at public intensive care units were related to the availability of equipment and personnel, while the main bottleneck at private units was the nephrologist assessment. A considerable proportion of the participants stated that they would change their approach to renal replacement therapy if there were no limitations on the availability of methods in their units.
There was wide variation in the availability of resources for renal replacement therapy and in the management of acute kidney injury in Brazilian intensive care units. This information should be taken into account when planning clinical trials focused on this topic in Brazil.
