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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis; Septic Shock
• Intervention / Treatment: Drug: magnesium sulfate; Other: standard care treatment

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asmaa K Elharony, PharmD; Phone Number: +201062593630; Email: asmaa.khamis252@gmail.com

Study Locations

• Egypt
  • Alexandria Governorate
    • Alexandria, Alexandria Governorate, Egypt, 21526
      • Alexandria Main University Hospital
      • Contact: Asmaa K Elharony, PharmD; Phone Number: +201062593630; Email: asmaa.khamis252@gmail.com
      • Principal Investigator: Asmaa K Elharony, PharmD
      • Sub-Investigator: Noha A Hamdy, PhD
      • Sub-Investigator: Marwan M ElBourini, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Patients will receive intravenous magnesium sulfate infusion to achieve and maintain upper normal serum magnesium levels (2.0 - 2.3 mg/dL).	Drug: magnesium sulfate; Intravenous magnesium sulfate infusions will be individualized and administered to achieve and maintain the target serum magnesium levels.
Active Comparator: Control group; Patients will receive standard care to maintain serum magnesium levels (1.7 - 1.9 mg/dL).	Other: standard care treatment; Patients will receive standard care required to maintain the target serum magnesium levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total cumulative dose of norepinephrine	Total cumulative dose of norepinephrine administered to the patient, measured in µg/kg.	Up to 60 days.
Duration of norepinephrine therapy	The time from the initiation of norepinephrine until discontinuation, measured in hours.	Up to 60 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU length of stay	Length of stay in the ICU, measured in days.	Up to 60 days.
Duration of mechanical ventilation	Duration of mechanical ventilation, measured in days.	Up to 60 days.
Mortality		Up to 60 days.

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Chair: Noha A Hamdy, PhD, Faculty of Pharmacy, Alexandria University.; Study Chair: Marwan M ElBourini, PhD, University of Alexandria; Principal Investigator: Asmaa K Elharony, PharmD, Faculty of Pharmacy, Alexandria University.

Publications and helpful links

General Publications

• World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
• Hansen BA, Bruserud O. Hypomagnesemia in critically ill patients. J Intensive Care. 2018 Mar 27;6:21. doi: 10.1186/s40560-018-0291-y. eCollection 2018.
• Chan JW, Yanase F, See E, McCue C, Yong ZT, Talbot LJ, Flanagan JPM, Eastwood GM. A pilot study of the pharmacokinetics of continuous magnesium infusion in critically ill patients. Crit Care Resusc. 2023 Oct 18;24(1):29-38. doi: 10.51893/2022.1.OA4. eCollection 2022 Mar 7.
• Noormandi A, Khalili H, Mohammadi M, Abdollahi A. Effect of magnesium supplementation on lactate clearance in critically ill patients with severe sepsis: a randomized clinical trial. Eur J Clin Pharmacol. 2020 Feb;76(2):175-184. doi: 10.1007/s00228-019-02788-w. Epub 2019 Dec 9.
• Shekhar S, Singh RB, Lata S, Singh A, De RR, Sharma P, Sinha S. Prevalence of Hypomagnesemia in ICU Patients at a Tertiary Care Center: A Prospective Observational Study. Cureus. 2025 Apr 3;17(4):e81656. doi: 10.7759/cureus.81656. eCollection 2025 Apr.
• Shi R, Hamzaoui O, De Vita N, Monnet X, Teboul JL. Vasopressors in septic shock: which, when, and how much? Ann Transl Med. 2020 Jun;8(12):794. doi: 10.21037/atm.2020.04.24.
• Prescott HC, Antonelli M, Alhazzani W, Moller MH, Alshamsi F, Azevedo LCP, Belley-Cote E, De Waele J, Derde L, Dionne JC, Evans L, Gershengorn HB, Hodgson CL, Honarmand K, Kesecioglu J, McIntyre L, Mer M, Nunnally ME, Oczkowski SJW, Rochwerg B, Akinola OO, Akuamoah-Boateng KA, Alberto L, Angus DC, Arabi YM, Azoulay E, Cecconi M, Convocar PF, De Pascale G, Doi K, Du B, Egi M, Elie-Turenne MC, Ferrer R, Fox-Robichaud A, French C, Freund Y, Gong MN, Hale CP, Hammond NE, Hashmi M, Heunks L, Iwashyna TJ, Jacob ST, Klompas M, Kwizera A, Leeies M, Lejnieks JD, Levy MM, Machado FR, Maia MO, Masur H, Maves RC, McGloughlin S, McPeake J, Mohr NM, Myatra SN, Ostermann M, Peake SL, Pletz MW, Roberts JA, Rosa RG, Sawyer RG, Schorr CA, Simpson SQ, Weng L, Wiersinga WJ, Rhodes A, Coopersmith CM. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2026. Crit Care Med. 2026 Apr 1;54(4):725-812. doi: 10.1097/CCM.0000000000007075. Epub 2026 Mar 23. No abstract available.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: norepinephrine; magnesium sulfate; vasopressors; magnesium level; ICU ( Intensive Care Unit )
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Sepsis; Shock, Septic; Sulfur Compounds; Inorganic Chemicals; Sulfur Acids; Sulfates; Sulfuric Acids; Magnesium Compounds; Magnesium Sulfate
• Other Study ID Numbers: 0109669

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No