Effect of Magnesium Sulfate Infusion Rate on Magnesium Retention in Critically Ill Patients

NCT01426165 | Terminated

• 1 other identifier: 10-10-2271
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Hypomagnesemia (low magnesium) is an electrolyte imbalance commonly found in up to 65% of critically ill patients. Possible consequences of hypomagnesemia include neuromuscular and neurologic dysfunction, heart arrhythmias, and alterations in other electrolytes. Data has shown that critically ill patients with hypomagnesemia have a significantly higher mortality rate than patients with a normal magnesium level. The most simple and commonly used test to diagnose hypomagnesemia is a serum magnesium level. Based on the magnesium level and symptoms of hypomagnesemia, patients may be replaced with either oral or intravenous (IV) magnesium. When replacing magnesium via the IV route, approximately half of the dose is retained by the body while the remainder is excreted in the urine. The low retention rate is due to the slow uptake of magnesium by cells and decreased magnesium reabsorption by the kidneys in response to the delivery of a large concentration of magnesium. The purpose of this study is to determine whether an eight hour compared to a four hour infusion of IV magnesium sulfate results in a greater retention of the magnesium dose.

Conditions

Primary Hypomagnesemia (Disorder)

Keywords

hypomagnesemia; magnesium; magnesium sulfate

Outcome Measures

Primary Outcomes (1)

• Amount of urinary excretion of magnesium after an 8g magnesium sulfate infusion delivered over 4 hours versus 8 hours.

  24 hours

Secondary Outcomes (1)

• Mean change in the serum magnesium level after an 8 gm magnesium sulfate infusion delivered over 4 hours and 8 hours

  24 hours

Study Arms (2)

Magnesium 8 grams over 4 hours

EXPERIMENTAL

Drug: Magnesium Sulfate

Magnesium 8 grams over 8 hours

EXPERIMENTAL

Drug: Magnesium Sulfate

Interventions

Magnesium Sulfate DRUG

8 grams over 4 or 8 hours depending on randomization

Also known as: magnesium

Magnesium 8 grams over 4 hours; Magnesium 8 grams over 8 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medicine ICU service patients
• \> 18 years old with
• hypomagnesemia defined by a serum magnesium level \< 2 mg/dL and the clinical decision by the rounding team to replace with parenteral magnesium sulfate
• must have an available IV line for magnesium infusion that may be used for up to 8 hours
• must have a Foley catheter

You may not qualify if:

• renal dysfunction defined by an estimated creatinine clearance (CrCl) \< 30 mL/min or have had an average of \< 0.5 mL/kg/hr of urine output over the previous 12 hours before the magnesium infusion is to begin
• Subjects must not have received a loop diuretic within the 12 hours prior to magnesium replacement and will further be excluded if they receive these medications during the magnesium replacement and urine collection time period
• Subjects with ostomies or acute diarrhea will be excluded due to the possibility of high gastrointestinal magnesium loss
• Subjects will be excluded if they have a physician order for magnesium sulfate to be infused over a specified time period
• If subjects are expected to be moved out of the ICU within the next 24 hours, they will not be considered for randomization due to potential lack of appropriate urine magnesium collection and follow up
• Each subject may only be enrolled in the study for one occurrence of hypomagnesemia

Sponsors & Collaborators

• CAMC Health System: lead
• Sarah & Pauline Maier Foundation, Inc.: collaborator

Study Sites (1)

Charleston Area Medical Center

Charleston, West Virginia, 25301, United States

Location

Related Publications (11)

• Ryzen E, Wagers PW, Singer FR, Rude RK. Magnesium deficiency in a medical ICU population. Crit Care Med. 1985 Jan;13(1):19-21. doi: 10.1097/00003246-198501000-00006.

  PMID: 3965244 BACKGROUND

• Epstein M, McGrath S, Law F. Proton-pump inhibitors and hypomagnesemic hypoparathyroidism. N Engl J Med. 2006 Oct 26;355(17):1834-6. doi: 10.1056/NEJMc066308. No abstract available.

  PMID: 17065651 BACKGROUND

• Broeren MA, Geerdink EA, Vader HL, van den Wall Bake AW. Hypomagnesemia induced by several proton-pump inhibitors. Ann Intern Med. 2009 Nov 17;151(10):755-6. doi: 10.7326/0003-4819-151-10-200911170-00016. No abstract available.

  PMID: 19920278 BACKGROUND

• al-Ghamdi SM, Cameron EC, Sutton RA. Magnesium deficiency: pathophysiologic and clinical overview. Am J Kidney Dis. 1994 Nov;24(5):737-52. doi: 10.1016/s0272-6386(12)80667-6.

  PMID: 7977315 BACKGROUND

• Rubeiz GJ, Thill-Baharozian M, Hardie D, Carlson RW. Association of hypomagnesemia and mortality in acutely ill medical patients. Crit Care Med. 1993 Feb;21(2):203-9. doi: 10.1097/00003246-199302000-00010.

  PMID: 8428470 BACKGROUND

• McLean RM. Magnesium and its therapeutic uses: a review. Am J Med. 1994 Jan;96(1):63-76. doi: 10.1016/0002-9343(94)90117-1.

  PMID: 8304365 BACKGROUND

• Zaloga GP. Interpretation of the serum magnesium level. Chest. 1989 Feb;95(2):257-8. doi: 10.1378/chest.95.2.257. No abstract available.

  PMID: 2914469 BACKGROUND

• CHESLEY LC, TEPPER I. Some effects of magnesium loading upon renal excretion of magnesium and certain other electrolytes. J Clin Invest. 1958 Oct;37(10):1362-72. doi: 10.1172/JCI103726. No abstract available.

  PMID: 13575537 BACKGROUND

• BARKER ES, ELKINTON JR, CLARK JK. Studies of the renal excretion of magnesium in man. J Clin Invest. 1959 Oct;38(10 Pt 1-2):1733-45. doi: 10.1172/JCI103952. No abstract available.

  PMID: 13796804 BACKGROUND

• Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.

  PMID: 1244564 BACKGROUND

• Agus ZS. Hypomagnesemia. J Am Soc Nephrol. 1999 Jul;10(7):1616-22. doi: 10.1681/ASN.V1071616. No abstract available.

  PMID: 10405219 BACKGROUND

MeSH Terms

Conditions

Hypomagnesemia primary

Interventions

Magnesium Sulfate; Magnesium

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Metals, Alkaline Earth; Elements; Metals, Light; Metals

Study Officials

• Jack L DePriest, MD

  WVU School of Medicine/Charleston Division

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist Specialist - Emergency Medicine/Critical Care; Director, PGY2 Pharmacy Residency in Critical Care

Study Record Dates

• First Submitted: August 24, 2011
• First Posted: August 31, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 4, 2014

Record last verified: 2014-01

Locations

US (1)