Você pesquisou por y - Critical Care Science (CCS)
Abstract
Rev Bras Ter Intensiva. 2018;30(3):253-263
DOI 10.5935/0103-507X.20180041
ANDROMEDA-SHOCK is an international, multicenter, randomized controlled trial comparing peripheral perfusion-targeted resuscitation to lactate-targeted resuscitation in patients with septic shock in order to test the hypothesis that resuscitation targeting peripheral perfusion will be associated with lower morbidity and mortality.
To report the statistical analysis plan for the ANDROMEDA-SHOCK trial.
We describe the trial design, primary and secondary objectives, patients, methods of randomization, interventions, outcomes, and sample size. We describe our planned statistical analysis for the primary, secondary and tertiary outcomes. We also describe the subgroup and sensitivity analyses. Finally, we provide details for presenting our results, including mock tables showing baseline characteristics, the evolution of hemodynamic and perfusion variables, and the effects of treatments on outcomes.
According to the best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and initiating the analyses. We anticipate that this procedure will prevent analysis bias and enhance the utility of the reported results.
Abstract
Rev Bras Ter Intensiva. 2018;30(3):253-263
DOI 10.5935/0103-507X.20180041
ANDROMEDA-SHOCK is an international, multicenter, randomized controlled trial comparing peripheral perfusion-targeted resuscitation to lactate-targeted resuscitation in patients with septic shock in order to test the hypothesis that resuscitation targeting peripheral perfusion will be associated with lower morbidity and mortality.
To report the statistical analysis plan for the ANDROMEDA-SHOCK trial.
We describe the trial design, primary and secondary objectives, patients, methods of randomization, interventions, outcomes, and sample size. We describe our planned statistical analysis for the primary, secondary and tertiary outcomes. We also describe the subgroup and sensitivity analyses. Finally, we provide details for presenting our results, including mock tables showing baseline characteristics, the evolution of hemodynamic and perfusion variables, and the effects of treatments on outcomes.
According to the best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and initiating the analyses. We anticipate that this procedure will prevent analysis bias and enhance the utility of the reported results.
Abstract
Rev Bras Ter 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
Rev Bras Ter 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
Rev Bras Ter Intensiva. 2018;30(3):286-293
DOI 10.5935/0103-507X.20180051
This study aimed to study the incidence of stress hyperglycemia in critically ill children and to investigate the etiological basis of the hyperglycemia based on homeostasis model assessment.
This was a prospective cohort study in one of the pediatric intensive care units of Cairo University, including 60 critically ill children and 21 healthy controls. Serum blood glucose, insulin, and C-peptide levels were measured within 24 hours of admission. Homeostasis model assessment was used to assess β-cell function and insulin sensitivity.
Hyperglycemia was estimated in 70% of patients. Blood glucose values ≥ 180mg/dL were associated with a poor outcome. Blood glucose levels were positively correlated with Pediatric Risk for Mortality (PRISM III) score and number of organ dysfunctions (p = 0.019 and p = 0.022, respectively), while insulin levels were negatively correlated with number of organ dysfunctions (r = −0.33, p = 0.01). Homeostasis model assessment revealed that 26 (43.3%) of the critically ill patients had low β-cell function, and 18 (30%) had low insulin sensitivity. Combined pathology was detected in 2 (3.3%) patients only. Low β-cell function was significantly associated with the presence of multi-organ dysfunction; respiratory, cardiovascular, and hematological dysfunctions; and the presence of sepsis.
β-Cell dysfunction appeared to be prevalent in our cohort and was associated with multi-organ dysfunction.
Abstract
Rev Bras Ter Intensiva. 2018;30(3):286-293
DOI 10.5935/0103-507X.20180051
This study aimed to study the incidence of stress hyperglycemia in critically ill children and to investigate the etiological basis of the hyperglycemia based on homeostasis model assessment.
This was a prospective cohort study in one of the pediatric intensive care units of Cairo University, including 60 critically ill children and 21 healthy controls. Serum blood glucose, insulin, and C-peptide levels were measured within 24 hours of admission. Homeostasis model assessment was used to assess β-cell function and insulin sensitivity.
Hyperglycemia was estimated in 70% of patients. Blood glucose values ≥ 180mg/dL were associated with a poor outcome. Blood glucose levels were positively correlated with Pediatric Risk for Mortality (PRISM III) score and number of organ dysfunctions (p = 0.019 and p = 0.022, respectively), while insulin levels were negatively correlated with number of organ dysfunctions (r = −0.33, p = 0.01). Homeostasis model assessment revealed that 26 (43.3%) of the critically ill patients had low β-cell function, and 18 (30%) had low insulin sensitivity. Combined pathology was detected in 2 (3.3%) patients only. Low β-cell function was significantly associated with the presence of multi-organ dysfunction; respiratory, cardiovascular, and hematological dysfunctions; and the presence of sepsis.
β-Cell dysfunction appeared to be prevalent in our cohort and was associated with multi-organ dysfunction.
Abstract
Rev Bras Ter Intensiva. 2018;30(3):294-300
DOI 10.5935/0103-507X.20180046
To determine the risk factors for extubation failure in the intensive care unit.
The present case-control study was conducted in an intensive care unit. Failed extubations were used as cases, while successful extubations were used as controls. Extubation failure was defined as reintubation being required within the first 48 hours of extubation.
Out of a total of 956 patients who were admitted to the intensive care unit, 826 were subjected to mechanical ventilation (86%). There were 30 failed extubations and 120 successful extubations. The proportion of failed extubations was 5.32%. The risk factors found for failed extubations were a prolonged length of mechanical ventilation of greater than 7 days (OR = 3.84, 95%CI = 1.01 - 14.56, p = 0.04), time in the intensive care unit (OR = 1.04, 95%CI = 1.00 - 1.09, p = 0.03) and the use of sedatives for longer than 5 days (OR = 4.81, 95%CI = 1.28 - 18.02; p = 0.02).
Pediatric patients on mechanical ventilation were at greater risk of failed extubation if they spent more time in the intensive care unit and if they were subjected to prolonged mechanical ventilation (longer than 7 days) or greater amounts of sedative use.
Abstract
Rev Bras Ter Intensiva. 2018;30(3):294-300
DOI 10.5935/0103-507X.20180046
To determine the risk factors for extubation failure in the intensive care unit.
The present case-control study was conducted in an intensive care unit. Failed extubations were used as cases, while successful extubations were used as controls. Extubation failure was defined as reintubation being required within the first 48 hours of extubation.
Out of a total of 956 patients who were admitted to the intensive care unit, 826 were subjected to mechanical ventilation (86%). There were 30 failed extubations and 120 successful extubations. The proportion of failed extubations was 5.32%. The risk factors found for failed extubations were a prolonged length of mechanical ventilation of greater than 7 days (OR = 3.84, 95%CI = 1.01 - 14.56, p = 0.04), time in the intensive care unit (OR = 1.04, 95%CI = 1.00 - 1.09, p = 0.03) and the use of sedatives for longer than 5 days (OR = 4.81, 95%CI = 1.28 - 18.02; p = 0.02).
Pediatric patients on mechanical ventilation were at greater risk of failed extubation if they spent more time in the intensive care unit and if they were subjected to prolonged mechanical ventilation (longer than 7 days) or greater amounts of sedative use.
Abstract
Rev Bras Ter Intensiva. 2018;30(3):301-307
DOI 10.5935/0103-507X.20180043
To translate and cross-culturally adapt the Functional Status Scale for hospitalized children into Brazilian Portuguese.
A methodological study of the translation and cross-cultural adaptation of the Functional Status Scale was conducted, according to the stages of translation, synthesis of translations, back-translation, synthesis of back-translations, expert committee analysis and pre-test with a sample of the target population. During the evaluation by the committee of experts, semantic, content and item analyses were performed.
The semantic, idiomatic, cultural and conceptual equivalences between the translated version and the original version were obtained, resulting in the Brazilian version of the Functional Status Scale. After the analysis by the expert committee, there were no problems regarding the cultural or conceptual equivalences because the items were pertinent to the Brazilian culture and few terms were modified. In the pre-test stage, the scale was applied by two evaluators to a sample of 25 children. Clarity and ease in answering the scale items were observed. Good inter-observer reliability was obtained, with an intraclass correlation coefficient of 0.85 (0.59 - 0.95).
The Functional Status Scale for pediatric use was translated and culturally adapted into Portuguese spoken in Brazil. The translated items were pertinent to the Brazilian culture and evaluated the dimensions proposed by the original instrument. Validation studies of this instrument are suggested to make it feasible for use in different regions of Brazil.
Abstract
Rev Bras Ter Intensiva. 2018;30(3):301-307
DOI 10.5935/0103-507X.20180043
To translate and cross-culturally adapt the Functional Status Scale for hospitalized children into Brazilian Portuguese.
A methodological study of the translation and cross-cultural adaptation of the Functional Status Scale was conducted, according to the stages of translation, synthesis of translations, back-translation, synthesis of back-translations, expert committee analysis and pre-test with a sample of the target population. During the evaluation by the committee of experts, semantic, content and item analyses were performed.
The semantic, idiomatic, cultural and conceptual equivalences between the translated version and the original version were obtained, resulting in the Brazilian version of the Functional Status Scale. After the analysis by the expert committee, there were no problems regarding the cultural or conceptual equivalences because the items were pertinent to the Brazilian culture and few terms were modified. In the pre-test stage, the scale was applied by two evaluators to a sample of 25 children. Clarity and ease in answering the scale items were observed. Good inter-observer reliability was obtained, with an intraclass correlation coefficient of 0.85 (0.59 - 0.95).
The Functional Status Scale for pediatric use was translated and culturally adapted into Portuguese spoken in Brazil. The translated items were pertinent to the Brazilian culture and evaluated the dimensions proposed by the original instrument. Validation studies of this instrument are suggested to make it feasible for use in different regions of Brazil.
Abstract
Rev Bras Ter Intensiva. 2018;30(3):308-316
DOI 10.5935/0103-507X.20180042
To assess the effect of the implementation of a palliative care program on do-not-resuscitate orders and intensive care unit utilization during terminal hospitalizations.
Data were retrospectively collected for all patients who died in a tertiary hospital in Brazil from May 2014 to September 2016. We analyzed the frequency of do-not-resuscitate orders and intensive care unit admissions among in-hospital deaths. Interrupted time series analyses were used to evaluate differences in trends of do-not-resuscitate orders and intensive care unit admissions before (17 months) and after (12 months) the implementation of a palliative care program.
We analyzed 48,372 hospital admissions and 1,071 in-hospital deaths. Deaths were preceded by do-not-resuscitate orders in 276 (25.8%) cases and admissions to the intensive care unit occurred in 814 (76%) cases. Do-not-resuscitate orders increased from 125 (20.4%) to 151 (33%) cases in the pre-implementation and post-implementation periods, respectively (p < 0.001). Intensive care unit admissions occurred in 469 (76.5%) and 345 (75.3%) cases in the pre-implementation and post-implementation periods, respectively (p = 0.654). Interrupted time series analyses confirmed a trend of increased do-not-resuscitate order registrations, from an increase of 0.5% per month pre-implementation to an increase of 2.9% per month post-implementation (p < 0.001), and demonstrated a trend of decreased intensive care unit utilization, from an increase of 0.6% per month pre-implementation to a decrease of -0.9% per month in the post-implementation period (p = 0.001).
The implementation of a palliative care program was associated with a trend of increased registration of do-not-resuscitate orders and a trend of decreased intensive care unit utilization during terminal hospitalizations.
Abstract
Rev Bras Ter Intensiva. 2018;30(3):308-316
DOI 10.5935/0103-507X.20180042
To assess the effect of the implementation of a palliative care program on do-not-resuscitate orders and intensive care unit utilization during terminal hospitalizations.
Data were retrospectively collected for all patients who died in a tertiary hospital in Brazil from May 2014 to September 2016. We analyzed the frequency of do-not-resuscitate orders and intensive care unit admissions among in-hospital deaths. Interrupted time series analyses were used to evaluate differences in trends of do-not-resuscitate orders and intensive care unit admissions before (17 months) and after (12 months) the implementation of a palliative care program.
We analyzed 48,372 hospital admissions and 1,071 in-hospital deaths. Deaths were preceded by do-not-resuscitate orders in 276 (25.8%) cases and admissions to the intensive care unit occurred in 814 (76%) cases. Do-not-resuscitate orders increased from 125 (20.4%) to 151 (33%) cases in the pre-implementation and post-implementation periods, respectively (p < 0.001). Intensive care unit admissions occurred in 469 (76.5%) and 345 (75.3%) cases in the pre-implementation and post-implementation periods, respectively (p = 0.654). Interrupted time series analyses confirmed a trend of increased do-not-resuscitate order registrations, from an increase of 0.5% per month pre-implementation to an increase of 2.9% per month post-implementation (p < 0.001), and demonstrated a trend of decreased intensive care unit utilization, from an increase of 0.6% per month pre-implementation to a decrease of -0.9% per month in the post-implementation period (p = 0.001).
The implementation of a palliative care program was associated with a trend of increased registration of do-not-resuscitate orders and a trend of decreased intensive care unit utilization during terminal hospitalizations.
Abstract
Rev Bras Ter Intensiva. 2018;30(3):317-326
DOI 10.5935/0103-507X.20180052
To characterize the transport of severely ill patients with extracorporeal respiratory or cardiovascular support.
A series of 18 patients in the state of São Paulo, Brazil is described. All patients were consecutively evaluated by a multidisciplinary team at the hospital of origin. The patients were rescued, and extracorporeal membrane oxygenation support was provided on site. The patients were then transported to referral hospitals for extracorporeal membrane oxygenation support. Data were retrieved from a prospectively collected database.
From 2011 to 2017, 18 patients aged 29 (25 - 31) years with a SAPS 3 of 84 (68 - 92) and main primary diagnosis of leptospirosis and influenza A (H1N1) virus were transported to three referral hospitals in São Paulo. A median distance of 39 (15 - 82) km was traveled on each rescue mission during a period of 360 (308 - 431) min. A median of one (0 - 2) nurse, three (2 - 3) physicians, and one (0 - 1) physical therapist was present per rescue. Seventeen rescues were made by ambulance, and one rescue was made by helicopter. The observed complications were interruption in the energy supply to the pump in two cases (11%) and oxygen saturation < 70% in two cases. Thirteen patients (72%) survived and were discharged from the hospital. Among the nonsurvivors, there were two cases of brain death, two cases of multiple organ dysfunction syndrome, and one case of irreversible pulmonary fibrosis.
Transportation with extracorporeal support occurred without serious complications, and the hospital survival rate was high.
Abstract
Rev Bras Ter Intensiva. 2018;30(3):317-326
DOI 10.5935/0103-507X.20180052
To characterize the transport of severely ill patients with extracorporeal respiratory or cardiovascular support.
A series of 18 patients in the state of São Paulo, Brazil is described. All patients were consecutively evaluated by a multidisciplinary team at the hospital of origin. The patients were rescued, and extracorporeal membrane oxygenation support was provided on site. The patients were then transported to referral hospitals for extracorporeal membrane oxygenation support. Data were retrieved from a prospectively collected database.
From 2011 to 2017, 18 patients aged 29 (25 - 31) years with a SAPS 3 of 84 (68 - 92) and main primary diagnosis of leptospirosis and influenza A (H1N1) virus were transported to three referral hospitals in São Paulo. A median distance of 39 (15 - 82) km was traveled on each rescue mission during a period of 360 (308 - 431) min. A median of one (0 - 2) nurse, three (2 - 3) physicians, and one (0 - 1) physical therapist was present per rescue. Seventeen rescues were made by ambulance, and one rescue was made by helicopter. The observed complications were interruption in the energy supply to the pump in two cases (11%) and oxygen saturation < 70% in two cases. Thirteen patients (72%) survived and were discharged from the hospital. Among the nonsurvivors, there were two cases of brain death, two cases of multiple organ dysfunction syndrome, and one case of irreversible pulmonary fibrosis.
Transportation with extracorporeal support occurred without serious complications, and the hospital survival rate was high.
Abstract
Rev Bras Ter Intensiva. 2018;30(3):327-332
DOI 10.5935/0103-507X.20180044
To evaluate the practice of dentistry in intensive care units.
An observational survey study was conducted in which questionnaires were sent via the online platform for collaboration in intensive care research in Brazil (AMIBnet). The study was carried out from June to October 2017. The questionnaires, which contained 26 closed questions about hospitals and dentistry practices in the intensive care units, were sent to 4,569 professionals from different specialties practicing in the units.
In total, 203 questionnaires were returned, resulting in a response rate of 4.44%. Most of the responses were from intensive care units in the Southeast region of the country (46.8%). Public hospitals (37.9%) and private hospitals (36.4%) had similar participation rates. Of the respondents, 55% indicated that a bedside dentistry service was present, and they were provided in different ways.
The presence of dentistry services and oral health service delivery training and protocols were correlated. The oral care methods varied greatly among the intensive care units surveyed.
Abstract
Rev Bras Ter Intensiva. 2018;30(3):327-332
DOI 10.5935/0103-507X.20180044
To evaluate the practice of dentistry in intensive care units.
An observational survey study was conducted in which questionnaires were sent via the online platform for collaboration in intensive care research in Brazil (AMIBnet). The study was carried out from June to October 2017. The questionnaires, which contained 26 closed questions about hospitals and dentistry practices in the intensive care units, were sent to 4,569 professionals from different specialties practicing in the units.
In total, 203 questionnaires were returned, resulting in a response rate of 4.44%. Most of the responses were from intensive care units in the Southeast region of the country (46.8%). Public hospitals (37.9%) and private hospitals (36.4%) had similar participation rates. Of the respondents, 55% indicated that a bedside dentistry service was present, and they were provided in different ways.
The presence of dentistry services and oral health service delivery training and protocols were correlated. The oral care methods varied greatly among the intensive care units surveyed.
