Septic ShockNCT07716956
Effect of Targeting Upper Normal Serum Magnesium Levels on Norepinephrine Requirements in Septic Shock Patients
A study testing magnesium sulfate in people with Septic Shock and Sepsis, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Sepsis
- What is being tested?
- magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adult patients (aged ≥18 years) diagnosed with septic shock.
- Resistant septic shock that requires corticosteroids.
Who cannot join
- Pregnancy.
- Baseline hypermagnesemia (serum magnesium level > 2.3 mg/dL).
- Renal impairment with creatinine clearance (CrCl) < 10 ml/min.
- Mixed shock.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria Main University Hospital
Alexandria, Alexandria Governorate, 21526
Asmaa K Elharony, PharmD, +201062593630, asmaa.khamis252@gmail.com
Asmaa K Elharony, PharmD
About this study
Official title: 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:
Read more
- Does maintaining upper normal serum magnesium levels lower the total cumulative dose and duration of norepinephrine therapy?
- 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.
- Conditions
- Septic Shock, Sepsis
- Being tested
- magnesium sulfate, standard care treatment
- Keywords
- vasopressors, norepinephrine, magnesium sulfate, magnesium level, ICU ( Intensive Care Unit )
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium sulfateDrug
Intravenous magnesium sulfate infusions will be individualized and administered to achieve and maintain the target serum magnesium levels.
standard care treatmentOther
Patients will receive standard care required to maintain the target serum magnesium levels.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: magnesium sulfate |
| Control group | Active comparator | Patients will receive standard care to maintain serum magnesium levels (1.7 - 1.9 mg/dL). Receives: Other: standard care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cumulative dose of norepinephrine
Total cumulative dose of norepinephrine administered to the patient, measured in µg/kg.
Measured: Up to 60 days.
Duration of norepinephrine therapy
The time from the initiation of norepinephrine until discontinuation, measured in hours.
Measured: Up to 60 days.
Secondary outcomes (3)
ICU length of stay
Length of stay in the ICU, measured in days.
Measured: Up to 60 days.
Duration of mechanical ventilation
Duration of mechanical ventilation, measured in days.
Measured: Up to 60 days.
Mortality
Measured: Up to 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start30 Jul 2026
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noha A Hamdy, PhD, Study chair, Faculty of Pharmacy, Alexandria University.Marwan M ElBourini, PhD, Study chair, University of AlexandriaAsmaa K Elharony, PharmD, Principal investigator, Faculty of Pharmacy, Alexandria University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716956
- Sponsor's protocol ID
- 0109669
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 24141714Hansen 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 29610664Chan 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 38046838Noormandi 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 31814044Shekhar 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 40322411Shi 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 32647719Prescott 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Targeting Upper Normal Serum Magnesium Levels on Norepinephrine Requirements in Septic Shock Patients: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07716956
- Acronym / sponsor ID
- 0109669
- Conditions
- Septic Shock, Sepsis
- Keywords
- vasopressors, norepinephrine, magnesium sulfate, magnesium level, ICU ( Intensive Care Unit )
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does maintaining upper normal serum magnesium levels lower the total cumulative dose and duration of norepinephrine therapy?
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: magnesium sulfatePatients will receive intravenous magnesium sulfate infusion to achieve and maintain upper normal serum magnesium levels (2.0 - 2.3 mg/dL). |
| Control group | Active comparator | Other: standard care treatmentPatients will receive standard care to maintain serum magnesium levels (1.7 - 1.9 mg/dL). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female adult patients (aged ≥18 years) diagnosed with septic shock.
- Resistant septic shock that requires corticosteroids.
Key exclusion criteria (4 listed)
- Pregnancy.
- Baseline hypermagnesemia (serum magnesium level > 2.3 mg/dL).
- Renal impairment with creatinine clearance (CrCl) < 10 ml/min.
- Mixed shock.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnesium sulfateIntravenous magnesium sulfate infusions will be individualized and administered to achieve and maintain the target serum magnesium levels. | Drug | Intervention group |
| standard care treatmentPatients will receive standard care required to maintain the target serum magnesium levels. | Other | Control group |
Primary outcome
Total cumulative dose of norepinephrine
Time frame: Up to 60 days.
Total cumulative dose of norepinephrine administered to the patient, measured in µg/kg.
Duration of norepinephrine therapy
Time frame: Up to 60 days.
The time from the initiation of norepinephrine until discontinuation, measured in hours.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 24141714World 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.
- Background: PubMed 29610664Hansen 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.
- Background: PubMed 38046838Chan 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.
- Background: PubMed 31814044Noormandi 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.
- Background: PubMed 40322411Shekhar 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.
- Background: PubMed 32647719Shi 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.
- Background: PubMed 41869847Prescott 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.
- Individual participant dataSharing planned: No
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnesium sulfate in people with Septic Shock and Sepsis, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asmaa K Elharony, PharmD (+201062593630, asmaa.khamis252@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cumulative dose of norepinephrine (time frame: Up to 60 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07716956, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.