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

ConditionsSeptic ShockSepsis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlexandria University

About this 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:

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Resistant septic shock that requires corticosteroids.

Disqualifiers

Pregnancy.

Baseline hypermagnesemia (serum magnesium level > 2.3 mg/dL).

Renal impairment with creatinine clearance (CrCl) < 10 ml/min.

Mixed shock.

Trial design

Design model

Parallel

Treatments tested in this trial

  • magnesium sulfate

    Drug

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

  • standard care treatment

    Other intervention

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexandria University

Lead sponsor

Source ClinicalTrials.gov
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