Abstract
Revista Brasileira de Terapia Intensiva. 11-04-2022;34(3):319-326
DOI 10.5935/0103-507X.20220101-en
To evaluate the effectiveness of the Welch Allyn Connex® Spot Monitor/Hillrom Connecta™ solution in activating the rapid response team in a timely manner compared to manual activation.
The Hillrom study is a single-center, open-label, superiority, cluster-randomized, parallel-group (1:1 allocation ratio) clinical trial that will be conducted in a tertiary hospital. Two sets of three wards with 28 beds will be included (one as the intervention cluster and the other as the control). The wards will be randomly assigned to use the Welch Allyn Connex® Spot Monitor/Hillrom Connecta™ automated solution (intervention cluster) or to maintain the usual routine (control cluster) regarding rapid response team activation. The primary outcome will be the absolute number of episodes of rapid response team triggering in an appropriate time; as secondary outcomes, clinical features (mortality, cardiac arrest, need for intensive care unit admission and duration of hospitalization) will be assessed according to clusters in an exploratory way. A sample size of 216 rapid response team activations was estimated to identify a possible difference between the groups. The protocol has been approved by the institutional Research Ethics Committee.
The Welch Allyn Connex® Spot Monitor/Hillrom Connecta™ automated solution is expected to be more effective in triggering the nurse call system to activate the rapid response team in a timely and adequate manner compared to manual triggering (usual practice).
NCT04648579
Abstract
Revista Brasileira de Terapia Intensiva. 06-24-2022;34(1):96-106
DOI 10.5935/0103-507X.20220004-en
Early reversion of sepsis-induced tissue hypoperfusion is essential for survival in septic shock. However, consensus regarding the best initial resuscitation strategy is lacking given that interventions designed for the entire population with septic shock might produce unnecessary fluid administration. This article reports the rationale, study design and analysis plan of the ANDROMEDA-2 study, which aims to determine whether a peripheral perfusion-guided strategy consisting of capillary refill time-targeted resuscitation based on clinical and hemodynamic phenotypes is associated with a decrease in a composite outcome of mortality, time to organ support cessation, and hospital length of stay compared to standard care in patients with early (< 4 hours of diagnosis) septic shock.
The ANDROMEDA-2 study is a multicenter, multinational randomized controlled trial. In the intervention group, capillary refill time will be measured hourly for 6 hours. If abnormal, patients will enter an algorithm starting with pulse pressure assessment. Patients with pulse pressure less than 40mmHg will be tested for fluid responsiveness and receive fluids accordingly. In patients with pulse pressure > 40mmHg, norepinephrine will be titrated to maintain diastolic arterial pressure > 50mmHg. Patients who fail to normalize capillary refill time after the previous steps will be subjected to critical care echocardiography for cardiac dysfunction evaluation and subsequent management. Finally, vasopressor and inodilator tests will be performed to further optimize perfusion. A sample size of 1,500 patients will provide 88% power to demonstrate superiority of the capillary refill time-targeted strategy.
If hemodynamic phenotype-based, capillary refill time-targeted resuscitation demonstrates to be a superior strategy, care processes in septic shock resuscitation can be optimized with bedside tools.
Abstract
Revista Brasileira de Terapia Intensiva. 06-24-2022;34(1):87-95
DOI 10.5935/0103-507x.20220003-en
The TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE) trial aims to assess whether a complex telemedicine intervention in intensive care units, which focuses on daily multidisciplinary rounds performed by remote intensivists, will reduce intensive care unit length of stay compared to usual care.
The TELESCOPE trial is a national, multicenter, controlled, open label, cluster randomized trial. The study tests the effectiveness of daily multidisciplinary rounds conducted by an intensivist through telemedicine in Brazilian intensive care units. The protocol was approved by the local Research Ethics Committee of the coordinating study center and by the local Research Ethics Committee from each of the 30 intensive care units, following Brazilian legislation. The trial is registered with ClinicalTrials. gov (NCT03920501). The primary outcome is intensive care unit length of stay, which will be analyzed accounting for the baseline period and cluster structure of the data and adjusted by prespecified covariates. Secondary exploratory outcomes included intensive care unit performance classification, in-hospital mortality, incidence of nosocomial infections, ventilator-free days at 28 days, rate of patients receiving oral or enteral feeding, rate of patients under light sedation or alert and calm, and rate of patients under normoxemia.
According to the trial’s best practice, we report our statistical analysis prior to locking the database and beginning analyses. We anticipate that this reporting practice will prevent analysis bias and improve the interpretation of the reported results.
Abstract
Revista Brasileira de Terapia Intensiva. 06-06-2022;34(1):1-12
DOI 10.5935/0103-507X.20220001-en
Several therapies are being used or proposed for COVID-19, and many lack appropriate evaluations of their effectiveness and safety. The purpose of this document is to develop recommendations to support decisions regarding the pharmacological treatment of patients hospitalized with COVID-19 in Brazil.
A group of 27 experts, including representatives of the Ministry of Health and methodologists, created this guideline. The method used for the rapid development of guidelines was based on the adoption and/or adaptation of existing international guidelines (GRADE ADOLOPMENT) and supported by the e-COVID-19 RecMap platform. The quality of the evidence and the preparation of the recommendations followed the GRADE method.
Sixteen recommendations were generated. They include strong recommendations for the use of corticosteroids in patients using supplemental oxygen, the use of anticoagulants at prophylactic doses to prevent thromboembolism and the nonuse of antibiotics in patients without suspected bacterial infection. It was not possible to make a recommendation regarding the use of tocilizumab in patients hospitalized with COVID-19 using oxygen due to uncertainties regarding the availability of and access to the drug. Strong recommendations against the use of hydroxychloroquine, convalescent plasma, colchicine, lopinavir + ritonavir and antibiotics in patients without suspected bacterial infection and also conditional recommendations against the use of casirivimab + imdevimab, ivermectin and rendesivir were made.
To date, few therapies have proven effective in the treatment of hospitalized patients with COVID-19, and only corticosteroids and prophylaxis for thromboembolism are recommended. Several drugs were considered ineffective and should not be used to provide the best treatment according to the principles of evidence-based medicine and promote economical resource use.
Abstract
Revista Brasileira de Terapia Intensiva. 01-24-2022;33(4):487-536
DOI 10.5935/0103-507X.0103-507X-rbti-20210080
The Sociedade Portuguesa de Cuidados Intensivos and the Infection and Sepsis Group have previously issued health service and management recommendations for critically ill patients with COVID-19. Due to the evolution of knowledge, the panel of experts was again convened to review the current evidence and issue updated recommendations.
A national panel of experts who declared that they had no conflicts of interest regarding the development of the recommendations was assembled. Operational questions were developed based on the PICO methodology, and a rapid systematic review was conducted by consulting different bibliographic sources. The panel determined the direction and strength of the recommendations using two Delphi rounds, conducted in accordance with the principles of the GRADE system. A strong recommendation received the wording “is recommended”, and a weak recommendation was written as “is suggested.”
A total of 48 recommendations and 30 suggestions were issued, covering the following topics: diagnosis of SARS-CoV-2 infection, coinfection and superinfection; criteria for admission, cure and suspension of isolation; organization of services; personal protective equipment; and respiratory support and other specific therapies (antivirals, immunomodulators and anticoagulation).
These recommendations, specifically oriented to the Portuguese reality but that may also apply to Portuguese-speaking African countries and East Timor, aim to support health professionals in the management of critically ill patients with COVID-19. They will be continuously reviewed to reflect the progress of our understanding and the treatment of this pathology.
Abstract
Revista Brasileira de Terapia Intensiva. 04-19-2021;33(1):38-47
DOI 10.5935/0103-507X.20210004
Triage for intensive care unit admission is a frequent event and is associated to worse clinical outcomes. The process of triage is variable and may be influenced by biases and prejudices, which could lead to potentially unfair decisions. The Brazilian Federal Council of Medicine (Conselho Federal de Medicina) has recently released a guideline for intensive care unit admission and discharge. The aim of this paper is to evaluate the ethical dilemmas related to the implementation of this guideline, through the accountability for reasonabless approach, known as A4R, as elaborated by Norman Daniels. We conclude that the guideline contemplates A4R conditions, but we observe that there is a need for indication of A4R-concordant criteria to operationalize the guidelines.
Abstract
Revista Brasileira de Terapia Intensiva. 04-19-2021;33(1):31-37
DOI 10.5935/0103-507X.20210003
The long-term effects caused by COVID-19 are unknown. The present study aims to assess factors associated with health-related quality of life and long-term outcomes among survivors of hospitalization for COVID-19 in Brazil.
This is a multicenter prospective cohort study nested in five randomized clinical trials designed to assess the effects of specific COVID-19 treatments in over 50 centers in Brazil. Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection will be followed-up for a period of 1 year by means of structured telephone interviews. The primary outcome is the 1-year utility score of health-related quality of life assessed by the EuroQol-5D3L. Secondary outcomes include all-cause mortality, major cardiovascular events, rehospitalizations, return to work or study, physical functional status assessed by the Lawton-Brody Instrumental Activities of Daily Living, dyspnea assessed by the modified Medical Research Council dyspnea scale, need for long-term ventilatory support, symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale, symptoms of posttraumatic stress disorder assessed by the Impact of Event Scale-Revised, and self-rated health assessed by the EuroQol-5D3L Visual Analog Scale. Generalized estimated equations will be performed to test the association between five sets of variables (1- demographic characteristics, 2- premorbid state of health, 3- characteristics of acute illness, 4- specific COVID-19 treatments received, and 5- time-updated postdischarge variables) and outcomes.
The study protocol was approved by the Research Ethics Committee of all participant institutions. The results will be disseminated through conferences and peer-reviewed journals.