Preoperative Ionized Magnesium Assessment

Preoperative Ionized Magnesium Assessment in Adults: an Observational Study on the Prevalence of Hypomagnesemia

The reported incidence of hypomagnesemia is approximately 2% in the general population. Hypomagnesemia is a common problem, occurring in nearly 10%of general hospitalized patients and 17% of hospitalized cancer patients. A higher incidence, up to 60% to 65%, has been found among intensive care unit patients. Hypomagnesemia can potentially cause fatal complications including ventricular arrhythmia, coronary artery spasm, and sudden death. It also associates with increased mortality and prolonged hospitalization.

Magnesium exists in three different forms in the body. In serum, 5-14% of the magnesium is reported to be complexed with anions such as phosphate, bicarbonate, and citrate, 19-33% is reported to be protein-bound (mainly to albumin), and 55-67% is found in the free ionized fraction. Because the amount of bound or complexed Mg can vary significantly, especially in illness, the ionized magnesium can vary in an unpredictable way. Conventional laboratory testing typically only measures total serum magnesium, which is often not reflective of ionized magnesium. Unlike ionized calcium, which is commonly measured and is also readily calculated from the total calcium and albumin levels, ionized magnesium is neither commonly measured nor easily calculated. One study reported that the level of ionized magnesium cannot be predicted by analysis of total magnesium and that the levels of ionized magnesium vary upon different pathophysiological conditions and between individuals. Furthermore, measurement of ionized magnesium in serum might be of great impact in patients for whom magnesium status is required, and the correlation of ionized magnesium and total magnesium is weak in patients for whom magnesium status is required as a whole, and this is the reason why the ionized magnesium should be measured directly.

To date, most of the clinical studies were evaluate the effect of hypomagnesemia on the outcome after surgery using the levels of total serum magnesium. However, the portion of extracellular magnesium that is physiologically active is in the various process is ionized magnesium. So, it is important to evaluate the level of ionized magnesium in surgical patients to predict the outcomes after surgery. Unfortunately, clinical trial regarding the effect of the concentrations of ionized magnesium on the surgical patients is limited.

Study Overview

• Status: Completed
• Conditions: Magnesium Deficiency
• Intervention / Treatment: Diagnostic test: Ionized magnesium

• Study Type: Observational
• Enrollment (Actual): 536

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery

Description

Inclusion Criteria:

• Patients undergoing surgery
• Aged ≥ 19
• Fasted ≥ 8 hours

Exclusion Criteria:

• Chronic kidney disease
• Aged < 19
• Fasted < 8 hours
• Patients who were taking magnesium

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ionized magnesium	Assess the ionized magnesium level	within 10 minutes after induction of anesthesia; 10 minutes before the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total magnesium	Assess the total magnesium level	within 10 minutes after induction of anesthesia

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Hyun-Jung Shin, MD., PhD., Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2021
• Primary Completion (Actual): March 18, 2022
• Study Completion (Actual): April 11, 2022

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 10, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Deficiency Diseases; Malnutrition; Magnesium Deficiency
• Other Study ID Numbers: B-2106-688-304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No