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NCT Number: NCT07716956

Effect of Targeting Upper Normal Serum Magnesium Levels on Norepinephrine Requirements in Septic Shock Patients

The goal of this clinical trial is to assess the effect of targeting upper normal serum magnesium levels on norepinephrine requirements in adult patients with septic shock.

The main questions it aims to answer are:

1. Does maintaining upper normal serum magnesium levels lower the total cumulative dose and duration of norepinephrine therapy? 2. Does this approach reduce the intensive care unit (ICU) length of stay, duration of mechanical ventilation and mortality?

This study will compare an intervention group to a control group to see the effect of targeting upper normal serum magnesium levels.

Participants will:

* Have their serum magnesium levels assessed at baseline (Day 0), at three-day intervals (Days 3, 6, 9) thereafter and on the day of norepinephrine discontinuation. * Receive individualized intravenous magnesium sulfate infusions to achieve and maintain the target serum magnesium levels. * Have their demographic data collected and be monitored closely for clinical data, vital signs, Mean Arterial Pressure (MAP), urine output and laboratory parameters.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Main University Hospital

Alexandria, Alexandria Governorate, 21526, Egypt

Location contact

Asmaa K Elharony, PharmD

CONTACT

[email protected]

+201062593630

Asmaa K Elharony, PharmD

PRINCIPAL_INVESTIGATOR

Marwan M ElBourini, PhD

SUB_INVESTIGATOR

Noha A Hamdy, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female adult patients (aged ≥18 years) diagnosed with septic shock.
  • Resistant septic shock that requires corticosteroids.

Exclusion criteria

  • Pregnancy.
  • Baseline hypermagnesemia (serum magnesium level > 2.3 mg/dL).
  • Renal impairment with creatinine clearance (CrCl) < 10 ml/min.
  • Mixed shock.

Treatment and study plan

Magnesium sulfate

Drug

Intravenous magnesium sulfate infusions will be individualized and administered to achieve and maintain the target serum magnesium levels.

Standard Care Treatment

Other

Patients will receive standard care required to maintain the target serum magnesium levels.

Primary outcomes

  1. Total cumulative dose of norepinephrine

    Time frame: Up to 60 days.

    Total cumulative dose of norepinephrine administered to the patient, measured in µg/kg.

  2. Duration of norepinephrine therapy

    Time frame: Up to 60 days.

    The time from the initiation of norepinephrine until discontinuation, measured in hours.

Secondary outcomes

  1. ICU length of stay

    Time frame: Up to 60 days.

    Length of stay in the ICU, measured in days.

  2. Duration of mechanical ventilation

    Time frame: Up to 60 days.

    Duration of mechanical ventilation, measured in days.

  3. Mortality

    Time frame: Up to 60 days.

Study contacts

Contact information is provided by the study sponsor or research team.

Asmaa K Elharony, PharmD

CONTACT

[email protected]

+201062593630

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Effect of Targeting Upper Normal Serum Magnesium Levels on Norepinephrine Requirements in Septic Shock Patients: a Randomized Controlled Trial.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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