Preoperative Ionized Magnesium Assessment

NCT04972344 | Completed

• 1 other identifier: B-2106-688-304
• Study Type: observational
• Target: 536
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Magnesium Deficiency

Outcome Measures

Primary Outcomes (1)

• Ionized magnesium

  Assess the ionized magnesium level

  within 10 minutes after induction of anesthesia; 10 minutes before the end of surgery

Secondary Outcomes (1)

• total magnesium

  within 10 minutes after induction of anesthesia

Interventions

Ionized magnesium DIAGNOSTIC_TEST

Assessment of ionized magnesium level

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Magnesium Deficiency

Condition Hierarchy (Ancestors)

Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Hyun-Jung Shin, MD., PhD.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 22, 2021
• Study Start: July 27, 2021
• Primary Completion: March 18, 2022
• Study Completion: April 11, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)