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

NCT07763665 | Not Yet Recruiting Phase 4

• 1 other identifier: effect of MgSO₄ in TBI
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Traumatic Brain Injuries

Keywords

anti-inflammatory effect of magnesium sulfate

Outcome Measures

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)

  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 (3)

• Glasgow Coma Scale (GCS) score

  day 7 post-injury and one month

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

  48 hours

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

  48 hours

Study Arms (2)

Group (A): Will receive intravenous magnesium sulfate MgSO₄.

EXPERIMENTAL

32 patients will receive * Loading Dose: Administered within 8 hours of trauma at a dose of 50 mg/kg via IV infusion over 1 hour. * Maintenance Dose: Administered at 25 mg/kg every 12 hours (twice daily) for 48 hours.

Drug: Magnesium sulfate (MgSO4)

Group (B): Will receive intravenous normal saline as a placebo.

EXPERIMENTAL

32 patients Will receive intravenous normal saline as a placebo.

Drug: Normal Saline

Interventions

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)

Group (A): Will receive intravenous magnesium sulfate MgSO₄.

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)

Group (B): Will receive intravenous normal saline as a placebo.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Magnesium Sulfate; Saline Solution

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Ehab Samir, Assistant lecturer

CONTACT

+201003078676; hobasamir12@gmail.com

Ghada Abolfadl, Prof.

CONTACT

+201005802086; ghadafadl@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 13, 2026

Record last verified: 2026-08