Health TrialsbyHealthPanel

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

ConditionTraumatic Brain Injuries
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAssiut University

About this trial

The primary objective of this study is to evaluate the biochemical efficacy of Magnesium Sulfate (MgSO₄) as an anti-inflammatory therapeutic agent in patients suffering from moderate traumatic brain injury (TBI) at Assiut University Hospitals by measuring Nucleotide-binding oligomerization domain-Like Receptor Pyrin domain-containing 3 (NLRP3) inflammasome-a multiprotein complex.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Magnesium sulfate (MgSO4)

    Drug

    evaluate the biochemical efficacy of Magnesium Sulfate (MgSO₄) as an anti-inflammatory therapeutic agent in patients suffering from moderate traumatic brain injury (TBI)

  • Normal Saline

    Drug

    evaluate the biochemical efficacy of Magnesium Sulfate (MgSO₄) as an anti-inflammatory therapeutic agent in patients suffering from moderate traumatic brain injury (TBI)

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Group (A): Will receive intravenous magnesium sulfate MgSO₄.Experimental treatment 1 intervention
Group B: Group (B): Will receive intravenous normal saline as a placebo.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Measured by the change in serum concentrations of the NLRP3 inflammasome complex

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)

Time frame
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)

Secondary outcomes

1

Glasgow Coma Scale (GCS) score

Glasgow Coma Scale (GCS) score

Time frame
day 7 post-injury and one month
2

Incidence of hypermagnesemia-related toxicity or drug-related adverse events

measurement of magnesium sulfate on admission and post intervention

Time frame
48 hours
3

ESR, CRP and serum Magnesium levels on admission (T₀) and 48 hours post-intervention (T₄₈)

ESR, CRP and serum Magnesium levels on admission (T₀) and 48 hours post-intervention (T₄₈)

Time frame
48 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: