- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07763665
Anti-inflammatory Effect of MgSO₄ in Patients With Moderate Traumatic Brain Injury by Measurming Nucleotide-binding Oligomerization Domain-Like Receptor Pyrin Domain-containing 3 (NLRP3) Inflammasome-a Multiprotein Complex
Anti-Inflammatory Effect of Magnesium Sulfate on the Outcomes of Patients With Moderate Traumatic Brain Injury.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Traumatic brain injury (TBI) remains a leading cause of mortality and long-term disability worldwide, disrupting both individual lives and healthcare systems. The pathophysiology of TBI is characterized by a biphasic process. The primary injury occurs at the moment of impact, resulting in immediate mechanical tissue disruption. This is followed by a complex cascade of cellular and molecular changes known as secondary brain injury, which develops hours to days later.
A cornerstone of this secondary injury pathway is neuroinflammation, driven by the activation of resident microglia and the infiltration of peripheral immune cells. Central to this inflammatory response is the assembly and activation of the Nucleotide-binding oligomerization domain-Like Receptor Pyrin domain-containing 3 (NLRP3) inflammasome-a multiprotein complex that triggers the maturation and release of potent pro-inflammatory cytokines, specifically interleukin-1β (IL-1β) and interleukin-18 (IL-18), accelerating neuronal apoptosis and blood-brain barrier dysfunction.
Magnesium sulfate (MgSO₄) has emerged as a promising neuroprotective candidate due to its multifaceted mechanism of action. Primarily, magnesium acts as a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, thereby mitigating glutamate-mediated excitotoxicity. Emerging molecular evidence further indicates that magnesium exerts potent anti-inflammatory effects by downregulating nuclear factor kappa B (NF-κB) activation and directly inhibiting the assembly of the NLRP3 inflammasome. Consequently, evaluating the clinical and molecular efficacy of MgSO₄ in TBI patients could offer a viable therapeutic pathway to suppress secondary neuroinflammation and optimize neurological recovery.
NLRP3 Inflammasome is a multiprotein complex consisting of three core components:
- Sensor (NLRP3)
- Adaptor (ASC)
- Effector (Caspase-1)
Its activation is regulated by a two-signal framework:
- Priming (Signal 1): Activates the nuclear factor kappa B(NF-κB) pathway to produce baseline NLRP3 components and inactive proteins (Pro-IL-1β, P ro-IL-18 andPro-IL-6).
- Activation (Signal 2): Triggered by cellular stress signals (such as Ca 2+ influx, K efflux, and mitochondrial distress).
Active Caspase-1 processes cytokines into their potent active forms and triggers a inflammatory cell death.
Magnesium sulfate (MgSO₄) has emerged as a promising neuroprotective candidate.
Magnesium sulfate exerts potent anti-inflammatory effects that can inhibit NLRP3 Inflammasome activation through 4 mechanisms:
- downregulating nuclear factor kappa B (NF-κB) activation and directly inhibiting the assembly of the NLRP3 inflammasome
- preventing extracellular Ca2+ influx and intracellular release
- Reducing K Efflux
- Preserving Mitochondrial Integrity
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
- Nome: Ehab Samir, Assistant lecturer
- Número de telefone: +201003078676
- E-mail: hobasamir12@gmail.com
Estude backup de contato
- Nome: Ghada Abolfadl, Prof.
- Número de telefone: +201005802086
- E-mail: ghadafadl@aun.edu.eg
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Male and female patients aged 18 to 60 years.
- Sustained a closed head trauma with the study drug infusion initiated within 8 hours of the injury.
- TBI confirmed by history and clinical examination.
- Patients with moderate (GCS = 9-12) traumatic brain injury.
- Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (diffuse injury II-IV, evacuated and non-evacuated mass lesion, Marshall's CT Classification ).
- Hemodynamic stability at the time of enrollment.
Exclusion Criteria:
- Patient Refusal
- Prolonged and/or uncorrectable hypoxia (PaO₂ < 60 mmHg) or persistent hypotension (systolic blood pressure < 90 mmHg) at the time of randomization.
- Cardiopulmonary arrest.
- Concomitant spinal cord injury.
- Pregnant or lactating females.
- Penetrating head injury.
- Associated other extra-cranial trauma or systemic polytrauma.
- Undergoing surgical interventions during the study.
- Pre-existing severe cardiac arrhythmia, heart block, or significant myocardial damage (documented on ECG).
- Known history of chronic renal failure or abnormal baseline renal function.
- Known hypersensitivity or allergic reaction to magnesium sulfate.
- Patients on chronic steroid therapy.
BMI>35 kg/m2.
-
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Group (A): Will receive intravenous magnesium sulfate MgSO₄.
32 patients will receive
|
evaluate the biochemical efficacy of Magnesium Sulfate (MgSO₄) as an anti-inflammatory therapeutic agent in patients suffering from moderate traumatic brain injury (TBI)
|
|
Experimental: Group (B): Will receive intravenous normal saline as a placebo.
32 patients Will receive intravenous normal saline as a placebo.
|
evaluate the biochemical efficacy of Magnesium Sulfate (MgSO₄) as an anti-inflammatory therapeutic agent in patients suffering from moderate traumatic brain injury (TBI)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Measured by the change in serum concentrations of the NLRP3 inflammasome complex
Prazo: Measured by the change in serum concentrations of the NLRP3 inflammasome complex components from baseline (T₀) to 48 hours post-intervention (T₄₈), quantified via Enzyme-Linked Immunosorbent Assay (ELISA)
|
Molecular Anti-inflammatory Response: Measured by the change in serum concentrations of the NLRP3 inflammasome complex components from baseline (T₀) to 48 hours post-intervention (T₄₈), quantified via Enzyme-Linked Immunosorbent Assay (ELISA)
|
Measured by the change in serum concentrations of the NLRP3 inflammasome complex components from baseline (T₀) to 48 hours post-intervention (T₄₈), quantified via Enzyme-Linked Immunosorbent Assay (ELISA)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Glasgow Coma Scale (GCS) score
Prazo: day 7 post-injury and one month
|
Glasgow Coma Scale (GCS) score
|
day 7 post-injury and one month
|
|
Incidence of hypermagnesemia-related toxicity or drug-related adverse events
Prazo: 48 hours
|
measurement of magnesium sulfate on admission and post intervention
|
48 hours
|
|
ESR, CRP and serum Magnesium levels on admission (T₀) and 48 hours post-intervention (T₄₈)
Prazo: 48 hours
|
ESR, CRP and serum Magnesium levels on admission (T₀) and 48 hours post-intervention (T₄₈)
|
48 hours
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Ferimentos e Lesões
- Trauma Craniocerebral
- Trauma, Sistema Nervoso
- Lesões cerebrais
- Lesões Cerebrais Traumáticas
- Compostos de enxofre
- Preparações farmacêuticas
- Produtos químicos inorgânicos
- Soluções cristalóides
- Soluções isotônicas
- Soluções
- Ácidos de enxofre
- Sulfatos
- Ácidos sulfúrico
- Compostos de magnésio
- Sulfato de Magnésio
- Solução salina
Outros números de identificação do estudo
- effect of MgSO₄ in TBI
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .