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.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07716956

Enrollment

Registered

2026-07-21

Start date

2026-07-01

Completion date

2027-07-01

Last updated

2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Septic Shock

Keywords

vasopressors, norepinephrine, magnesium sulfate, magnesium level, ICU ( Intensive Care Unit )

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: 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

DRUGmagnesium sulfate

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Egypt

Contacts

CONTACTAsmaa K Elharony, PharmD

asmaa.khamis252@gmail.com+201062593630

STUDY_CHAIRNoha A Hamdy, PhD

Faculty of Pharmacy, Alexandria University.

STUDY_CHAIRMarwan M ElBourini, PhD

University of Alexandria

PRINCIPAL_INVESTIGATORAsmaa K Elharony, PharmD