ClinicalTrials.gg
RecruitingNCT07716956Updated Oct 6, 2026

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

An interventional study of magnesium sulfate and standard care treatment in Septic Shock and Sepsis, sponsored by Alexandria University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Alexandria University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Updated Oct 6, 2026Now RecruitingSite recruiting status changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.
02

Conditions studied

  • Septic Shock
  • Sepsis

Keywords

  • vasopressors
  • norepinephrine
  • magnesium sulfate
  • magnesium level
  • ICU ( Intensive Care Unit )
03

In context

Shock, Septic

1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.

This study's planned enrollment of 60 is below the median of 79 across 636 interventional studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy.
  • Baseline hypermagnesemia (serum magnesium level > 2.3 mg/dL).
  • Renal impairment with (CrCl) \< 10 ml/min.
  • Mixed shock.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • Active comparator
    Control group

    Patients will receive standard care to maintain serum magnesium levels (1.7 - 1.9 mg/dL).

    Other: standard care treatment

Interventions

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

  • Otherstandard care treatment

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

06

What researchers measure

Primary outcomes

  1. Total cumulative dose of norepinephrine

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

    Time frame: Up to 60 days.

  2. Duration of norepinephrine therapy

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

    Time frame: Up to 60 days.

Secondary outcomes

  1. ICU length of stay

    Length of stay in the ICU, measured in days.

    Time frame: Up to 60 days.

  2. Duration of mechanical ventilation

    Duration of mechanical ventilation, measured in days.

    Time frame: Up to 60 days.

  3. Mortality

    Time frame: Up to 60 days.

07

Study locations

1 of 1 sites recruiting
  • Alexandria Main University Hospital
    Alexandria, Alexandria Governorate 21526, Egypt
    Recruiting
    • Asmaa K Elharony, PharmD · Contactasmaa.khamis252@gmail.com · +201062593630
    • Asmaa K Elharony, PharmD · Principal investigator
    • Noha A Hamdy, PhD · Sub investigator
    • Marwan M ElBourini, PhD · Sub investigator
08

References and documents

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. PubMed 24141714 ↗
  • 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. PubMed 29610664 ↗
  • 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. PubMed 38046838 ↗
  • 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. PubMed 31814044 ↗
  • 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. PubMed 40322411 ↗
  • 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. PubMed 32647719 ↗
  • 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. PubMed 41869847 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 6, 2026
Sites
Alexandria Main University Hospital is now Recruiting
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Not yet recruiting→Recruiting
    Alexandria Main University Hospital is now Recruiting
    + 1 other change: date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07716956
Responsible party
Sponsor
First posted
Jul 21, 2026
Start date
Jul 30, 2026
Primary completion
Apr 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Oct 6, 2026

Study contacts

Asmaa K Elharony, PharmD
Contact
asmaa.khamis252@gmail.com
+201062593630
Noha A Hamdy, PhD
study chair · Faculty of Pharmacy, Alexandria University.
Marwan M ElBourini, PhD
study chair · University of Alexandria
Asmaa K Elharony, PharmD
principal investigator · Faculty of Pharmacy, Alexandria University.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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