ABSTRACT Objective: To explain the rationale and protocol of the methods and analyses to be used in the LIVER-PAM randomized clinical trial, which seeks to understand whether a higher mean arterial pressure is capable of reducing the incidence of renal dysfunction postoperatively after liver transplantation. Methods: LIVER-PAM is an open-label, randomized, controlled, singlecenter clinical trial. Patients randomized to the intervention group will have a mean arterial pressure of 85 - 90mmHg in the initial 24 hours of postoperative management, while patients in the control group will have a mean arterial pressure of 65 - 70mmHg in the same period. A sample of 174 patients will be required to demonstrate a 20% reduction in the absolute incidence of renal dysfunction, with a power of 80% and an alpha of 0.05. Conclusion: If a 20% reduction in the absolute incidence of renal dysfunction in the postoperative period of liver transplantation is achieved with higher target mean arterial pressure in the first 24 hours, this would represent an inexpensive and simple therapy for improving current outcomes in the management of liver transplant patients. ClinicalTrials.gov Registry:NCT05068713 Objective LIVERPAM LIVER PAM trial Methods openlabel, openlabel open label, label open-label controlled 8 mmHg 2 6 17 20 80 005 0 05 0.05 Conclusion ClinicalTrialsgov ClinicalTrials gov RegistryNCT05068713 RegistryNCT Registry NCT05068713 NCT Registry:NCT0506871 1 00 0.0 RegistryNCT0506871 NCT0506871 Registry:NCT050687 0. RegistryNCT050687 NCT050687 Registry:NCT05068 RegistryNCT05068 NCT05068 Registry:NCT0506 RegistryNCT0506 NCT0506 Registry:NCT050 RegistryNCT050 NCT050 Registry:NCT05 RegistryNCT05 NCT05 Registry:NCT0 RegistryNCT0 NCT0 Registry:NCT
RESUMO Objetivo: Explicitar o racional e o protocolo de métodos e análises a serem utilizadas no ensaio clínico randomizado LIVER-PAM, que busca entender se um nível mais alto de pressão arterial média é capaz de reduzir a incidência de disfunção renal no pós-operatório de transplante hepático. Métodos: O LIVER-PAM é um estudo clínico randomizado, controlado, unicêntrico e aberto. Pacientes randomizados para o grupo intervenção terão como alvo de pressão arterial média 85 - 90mmHg nas 24 horas iniciais do manejo pós-operatório, enquanto pacientes do grupo controle terão como alvo de pressão arterial média 65 - 70mmHg no mesmo período. Uma amostra de 174 pacientes será necessária para demonstrar redução de 20% na incidência absoluta de disfunção renal, com poder de 80% e alfa de 0,05. Conclusão: Se a redução de 20% da incidência absoluta de disfunção renal no pós-operatório de transplante hepático for obtida com alvos maiores de pressão arterial média nas primeiras 24 horas, o manejo do paciente nesse cenário encontraria uma terapia barata e simples para a melhoria dos desfechos atuais. Registro Cliniclatrials.gov:NCT05068713 Objetivo LIVERPAM, LIVERPAM LIVER PAM, PAM pósoperatório pós operatório Métodos controlado aberto 8 mmHg 2 pósoperatório, operatório, 6 período 17 20 80 005 0 05 0,05 Conclusão atuais Cliniclatrials.govNCT05068713 CliniclatrialsgovNCT05068713 CliniclatrialsgovNCT Cliniclatrials.gov NCT05068713 Cliniclatrials gov NCT Cliniclatrials.gov:NCT0506871 1 00 0,0 govNCT05068713 govNCT Cliniclatrials.govNCT0506871 CliniclatrialsgovNCT0506871 Cliniclatrialsgov NCT0506871 Cliniclatrials.gov:NCT050687 0, govNCT0506871 Cliniclatrials.govNCT050687 CliniclatrialsgovNCT050687 NCT050687 Cliniclatrials.gov:NCT05068 govNCT050687 Cliniclatrials.govNCT05068 CliniclatrialsgovNCT05068 NCT05068 Cliniclatrials.gov:NCT0506 govNCT05068 Cliniclatrials.govNCT0506 CliniclatrialsgovNCT0506 NCT0506 Cliniclatrials.gov:NCT050 govNCT0506 Cliniclatrials.govNCT050 CliniclatrialsgovNCT050 NCT050 Cliniclatrials.gov:NCT05 govNCT050 Cliniclatrials.govNCT05 CliniclatrialsgovNCT05 NCT05 Cliniclatrials.gov:NCT0 govNCT05 Cliniclatrials.govNCT0 CliniclatrialsgovNCT0 NCT0 Cliniclatrials.gov:NCT govNCT0 Cliniclatrials.govNCT