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Not yet recruiting NCT07716956

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

No phase Interventional Septic Shock Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: magnesium sulfate, standard care treatment.
Who it may be relevant to
Registry conditions: Septic Shock, Sepsis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug magnesium sulfate
    Intravenous magnesium sulfate infusions will be individualized and administered to achieve and maintain the target serum magnesium levels.
  • Other standard care treatment
    Patients will receive standard care required to maintain the target serum magnesium levels.

Primary outcome measures

  • Total cumulative dose of norepinephrine [Time frame: Up to 60 days.]
  • Duration of norepinephrine therapy [Time frame: Up to 60 days.]
Secondary outcome measures (3)
  • ICU length of stay [Time frame: Up to 60 days.]
  • Duration of mechanical ventilation [Time frame: Up to 60 days.]
  • Mortality [Time frame: Up to 60 days.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Egypt · 1 center
  • Alexandria Main University Hospital — Alexandria

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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, Ferre PMID 41869847

Identifiers

NCT: NCT07716956 · 0109669

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗