NCT07716956

Brief 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:

  • 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Jul 2026Jul 2027

Study Start

First participant enrolled

July 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

9 months

First QC Date

July 6, 2026

Last Update Submit

July 16, 2026

Conditions

Septic ShockSepsis

Keywords

vasopressorsnorepinephrinemagnesium sulfatemagnesium levelICU ( Intensive Care Unit )

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • ICU length of stay

    Up to 60 days.

  • Duration of mechanical ventilation

    Up to 60 days.

  • Mortality

    Up to 60 days.

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Other: standard care treatment

Interventions

magnesium sulfateDRUG

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

Intervention group
standard care treatmentOTHER

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Main University Hospital

Alexandria, Alexandria Governorate, 21526, Egypt

Location

Related Publications (7)

  • 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.

    PMID: 24141714BACKGROUND

  • 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.

    PMID: 29610664BACKGROUND

  • 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.

    PMID: 38046838BACKGROUND

  • 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.

    PMID: 31814044BACKGROUND

  • 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.

    PMID: 40322411BACKGROUND

  • 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.

    PMID: 32647719BACKGROUND

  • 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.

    PMID: 41869847BACKGROUND

MeSH Terms

Conditions

Shock, SepticSepsis

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Noha A Hamdy, PhD

    Faculty of Pharmacy, Alexandria University.

    STUDY CHAIR

  • Marwan M ElBourini, PhD

    University of Alexandria

    STUDY CHAIR

  • Asmaa K Elharony, PharmD

    Faculty of Pharmacy, Alexandria University.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Asmaa K Elharony, PharmD

CONTACT

+201062593630asmaa.khamis252@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 21, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

July 21, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)