RESUMO Objetivo: Descrever os efeitos do uso de soluções balanceadas nos desfechos de curto prazo de pacientes com traumatismo craniencefálico incluídos no estudo BaSICS. Métodos: Os pacientes foram randomizados para receber solução salina 0,9% ou solução balanceada durante a internação em unidade de terapia intensiva. O desfecho primário foi mortalidade em 90 dias, já os desfechos secundários foram dias de vida e sem internação em unidade de terapia intensiva aos 28 dias. O desfecho primário foi avaliado por regressão logística bayesiana. O desfecho secundário foi avaliado usando regressão beta-binomial inflada de zeros bayesiana. Resultados: Incluímos 483 pacientes (236 no braço de solução salina 0,9% e 247 no braço de solução balanceada). Foram incluídos 338 pacientes (70%) com pontuação na escala de coma de Glasgow ≤ 12. A probabilidade geral de que soluções balanceadas estivessem associadas a maior mortalidade em 90 dias foi de 0,98 (RC de 1,48; ICr95% 1,04 - 2,09). Esse aumento de mortalidade foi particularmente perceptível em pacientes com pontuação na escala de coma de Glasgow abaixo de 6 no momento da inclusão (probabilidade de dano de 0,99). Soluções balanceadas foram associadas a -1,64 dia de vida e sem internação em unidade de terapia intensiva aos 28 dias (ICr95% -3,32 - 0,00) com probabilidade de dano de 0,97. Conclusão: Houve alta probabilidade de que soluções balanceadas estivessem associadas a alta mortalidade em 90 dias, menos dias de vida e sem internação em unidade de terapia intensiva aos 28 dias. ClinicalTrials.gov:NCT02875873 Objetivo BaSICS Métodos 09 0 9 0,9 2 bayesiana betabinomial beta binomial Resultados 48 236 (23 24 balanceada. . balanceada) 33 70% 70 (70% 12 098 98 RC 1,48 148 1 ICr95 ICr 104 04 1,0 2,09. 209 2,09 2,09) 0,99. 099 0,99 99 0,99) 1,64 164 64 -1,6 (ICr95 3,32 332 3 32 -3,3 0,00 000 00 097 97 0,97 Conclusão ClinicalTrials.govNCT02875873 ClinicalTrialsgovNCT02875873 ClinicalTrialsgovNCT ClinicalTrials.gov NCT02875873 ClinicalTrials gov NCT ClinicalTrials.gov:NCT0287587 0, 4 23 (2 7 (70 1,4 14 ICr9 10 1, 20 2,0 1,6 16 -1, (ICr9 3,3 -3, 0,0 govNCT02875873 govNCT ClinicalTrials.govNCT0287587 ClinicalTrialsgovNCT0287587 ClinicalTrialsgov NCT0287587 ClinicalTrials.gov:NCT028758 ( (7 2, -1 (ICr 3, -3 govNCT0287587 ClinicalTrials.govNCT028758 ClinicalTrialsgovNCT028758 NCT028758 ClinicalTrials.gov:NCT02875 govNCT028758 ClinicalTrials.govNCT02875 ClinicalTrialsgovNCT02875 NCT02875 ClinicalTrials.gov:NCT0287 govNCT02875 ClinicalTrials.govNCT0287 ClinicalTrialsgovNCT0287 NCT0287 ClinicalTrials.gov:NCT028 govNCT0287 ClinicalTrials.govNCT028 ClinicalTrialsgovNCT028 NCT028 ClinicalTrials.gov:NCT02 govNCT028 ClinicalTrials.govNCT02 ClinicalTrialsgovNCT02 NCT02 ClinicalTrials.gov:NCT0 govNCT02 ClinicalTrials.govNCT0 ClinicalTrialsgovNCT0 NCT0 ClinicalTrials.gov:NCT govNCT0 ClinicalTrials.govNCT
ABSTRACT Objective: To describe the effects of balanced solution use on the short-term outcomes of patients with traumatic brain injury enrolled in BaSICS trial. Methods: Patients were randomized to receive either 0.9% saline or balanced solution during their intensive care unit stay. The primary endpoint was 90-day mortality, and the secondary outcomes were days alive and free of intensive care unit stay at 28 days. The primary endpoint was assessed using Bayesian logistic regression. The secondary endpoint was assessed using a Bayesian zero-inflated beta binomial regression. Results: We included 483 patients (236 in the 0.9% saline arm and 247 in the balanced solution arm). A total of 338 patients (70%) with a Glasgow coma scale score ≤ 12 were enrolled. The overall probability that balanced solutions were associated with higher 90-day mortality was 0.98 (OR 1.48; 95%CrI 1.04 - 2.09); this mortality increment was particularly noticeable in patients with a Glasgow coma scale score below 6 at enrollment (probability of harm of 0.99). Balanced solutions were associated with -1.64 days alive and free of intensive care unit at 28 days (95%CrI -3.32 - 0.00) with a probability of harm of 0.97. Conclusion: There was a high probability that balanced solutions were associated with high 90-day mortality and fewer days alive and free of intensive care units at 28 days. ClinicalTrials.gov:NCT02875873 Objective shortterm short term trial Methods 09 0 9 0.9 90day day 90 2 regression zeroinflated zero inflated Results 48 236 (23 24 arm. . arm) 33 70% 70 (70% 1 098 98 OR 1.48 148 95CrI CrI 95 104 04 1.0 2.09 209 2.09) 0.99. 099 0.99 99 0.99) 1.64 164 64 -1.6 3.32 332 3 32 -3.3 0.00 000 00 097 97 0.97 Conclusion ClinicalTrials.govNCT02875873 ClinicalTrialsgovNCT02875873 ClinicalTrialsgovNCT ClinicalTrials.gov NCT02875873 ClinicalTrials gov NCT ClinicalTrials.gov:NCT0287587 0. 4 23 (2 7 (70 1.4 14 10 1. 2.0 20 1.6 16 -1. 3.3 -3. 0.0 govNCT02875873 govNCT ClinicalTrials.govNCT0287587 ClinicalTrialsgovNCT0287587 ClinicalTrialsgov NCT0287587 ClinicalTrials.gov:NCT028758 ( (7 2. -1 3. -3 govNCT0287587 ClinicalTrials.govNCT028758 ClinicalTrialsgovNCT028758 NCT028758 ClinicalTrials.gov:NCT02875 govNCT028758 ClinicalTrials.govNCT02875 ClinicalTrialsgovNCT02875 NCT02875 ClinicalTrials.gov:NCT0287 govNCT02875 ClinicalTrials.govNCT0287 ClinicalTrialsgovNCT0287 NCT0287 ClinicalTrials.gov:NCT028 govNCT0287 ClinicalTrials.govNCT028 ClinicalTrialsgovNCT028 NCT028 ClinicalTrials.gov:NCT02 govNCT028 ClinicalTrials.govNCT02 ClinicalTrialsgovNCT02 NCT02 ClinicalTrials.gov:NCT0 govNCT02 ClinicalTrials.govNCT0 ClinicalTrialsgovNCT0 NCT0 ClinicalTrials.gov:NCT govNCT0 ClinicalTrials.govNCT