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| [PMID]: | 28973227 |
| [Au] Autor: | Andrews B; Semler MW; Muchemwa L; Kelly P; Lakhi S; Heimburger DC; Mabula C; Bwalya M; Bernard GR |
| [Ad] Endereço: | Institute for Global Health, Vanderbilt University Medical Center, Nashville, Tennessee. |
| [Ti] Título: | Effect of an Early Resuscitation Protocol on In-hospital Mortality Among Adults With Sepsis and Hypotension: A Randomized Clinical Trial. |
| [So] Source: | JAMA;318(13):1233-1240, 2017 10 03. | | [Is] ISSN: | 1538-3598 |
| [Cp] País de publicação: | United States |
| [La] Idioma: | eng |
| [Ab] Resumo: | Importance: The effect of an early resuscitation protocol on sepsis outcomes in developing countries remains unknown. Objective: To determine whether an early resuscitation protocol with administration of intravenous fluids, vasopressors, and blood transfusion decreases mortality among Zambian adults with sepsis and hypotension compared with usual care. Design, Setting, and Participants: Randomized clinical trial of 212 adults with sepsis (suspected infection plus ≥2 systemic inflammatory response syndrome criteria) and hypotension (systolic blood pressure ≤90 mm Hg or mean arterial pressure ≤65 mm Hg) presenting to the emergency department at a 1500-bed referral hospital in Zambia between October 22, 2012, and November 11, 2013. Data collection concluded December 9, 2013. Interventions: Patients were randomized 1:1 to either (1) an early resuscitation protocol for sepsis (n = 107) that included intravenous fluid bolus administration with monitoring of jugular venous pressure, respiratory rate, and arterial oxygen saturation and treatment with vasopressors targeting mean arterial pressure (≥65 mm Hg) and blood transfusion (for patients with a hemoglobin level <7 g/dL) or (2) usual care (n = 105) in which treating clinicians determined hemodynamic management. Main Outcomes and Measures: The primary outcome was in-hospital mortality and the secondary outcomes included the volume of intravenous fluid received and receipt of vasopressors. Results: Among 212 patients randomized to receive either the sepsis protocol or usual care, 3 were ineligible and the remaining 209 completed the study and were included in the analysis (mean [SD] age, 36.7 [12.4] years; 117 men [56.0%]; 187 [89.5%] positive for the human immunodeficiency virus). The primary outcome of in-hospital mortality occurred in 51 of 106 patients (48.1%) in the sepsis protocol group compared with 34 of 103 patients (33.0%) in the usual care group (between-group difference, 15.1% [95% CI, 2.0%-28.3%]; relative risk, 1.46 [95% CI, 1.04-2.05]; P = .03). In the 6 hours after presentation to the emergency department, patients in the sepsis protocol group received a median of 3.5 L (interquartile range, 2.7-4.0 L) of intravenous fluid compared with 2.0 L (interquartile range, 1.0-2.5 L) in the usual care group (mean difference, 1.2 L [95% CI, 1.0-1.5 L]; P < .001). Fifteen patients (14.2%) in the sepsis protocol group and 2 patients (1.9%) in the usual care group received vasopressors (between-group difference, 12.3% [95% CI, 5.1%-19.4%]; P < .001). Conclusions and Relevance: Among adults with sepsis and hypotension, most of whom were positive for HIV, in a resource-limited setting, a protocol for early resuscitation with administration of intravenous fluids and vasopressors increased in-hospital mortality compared with usual care. Further studies are needed to understand the effects of administration of intravenous fluid boluses and vasopressors in patients with sepsis across different low- and middle-income clinical settings and patient populations. Trial Registration: clinicaltrials.gov Identifier: NCT01663701. |
| [Mh] Termos MeSH primário: |
Hidratação
Mortalidade Hospitalar
Hipotensão/terapia
Ressuscitação/métodos
Sepse/terapia
Vasoconstritores/uso terapêutico
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| [Mh] Termos MeSH secundário: |
Adulto
Transfusão de Sangue
Protocolos Clínicos
Feminino
Soropositividade para HIV/complicações
Seres Humanos
Hipotensão/etiologia
Infusões Intravenosas
Soluções Isotônicas/uso terapêutico
Estimativa de Kaplan-Meier
Masculino
Sepse/complicações
Sepse/mortalidade
Tempo para o Tratamento
Zâmbia
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| [Pt] Tipo de publicação: | JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL |
[Nm] Nome de substância:
| 0 (Isotonic Solutions); 0 (Vasoconstrictor Agents); 0 (crystalloid solutions) |
| [Em] Mês de entrada: | 1710 |
| [Cu] Atualização por classe: | 171109 |
[Lr] Data última revisão:
| 171109 |
| [Sb] Subgrupo de revista: | AIM; IM |
| [Da] Data de entrada para processamento: | 171004 |
| [Cl] Clinical Trial: | ClinicalTrial
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| [St] Status: | MEDLINE |
| [do] DOI: | 10.1001/jama.2017.10913 |
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