Primary Hypomagnesemia (Disorder)NCT01426165
Effect of Magnesium Sulfate Infusion Rate on Magnesium Retention in Critically Ill Patients
A study testing Magnesium Sulfate in people with Primary Hypomagnesemia (Disorder), run by CAMC Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hypomagnesemia (Disorder)
- What is being tested?
- Magnesium Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Charleston Area Medical Center
Charleston, West Virginia, 25301
About this study
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.
Read the detailed description
Hypomagnesemia is a common electrolyte disturbance that affects up to 65% of intensive care unit (ICU) patients with normal renal function. Causes of hypomagnesemia are attributed to either gastrointestinal (secretory loss, impaired absorption or reabsorption, acute pancreatitis) or renal losses (alcohol, hypercalcemia, volume expansion, loop or thiazide diuretics, nephrotoxic medications, renal tubular dysfunction, inborn disorders). Consequences of magnesium deficiency are not benign and may include neuromuscular and neurologic dysfunction, cardiac arrhythmias and concomitant electrolyte abnormalities including hypokalemia and hypocalcemia. Hypomagnesemia has been associated with a significantly greater mortality rate in critically ill medical patients compared to normomagnesemic patients. In a study conducted by Rubeiz et al, 46% (17/37) of hypomagnesemic patients in the medical ICU died compared to 25% (37/147) of normomagnesemic patients (p < 0.05).
It can be difficult to assess patients for hypomagnesemia because of the unreliable relationship between serum and tissue magnesium levels. Approximately 1% of total body magnesium is found in the extracellular fluid while the remaining 99% is distributed among the bones, muscles, and soft tissues. Approximately 60% of serum magnesium is free ions; 33% is bound to proteins and 7% is complexed with anions. The most simple and commonly used test to diagnose hypomagnesemia is the total serum magnesium level which reflects free magnesium along with complexed and protein bound magnesium. The serum magnesium level, however, is not always accurate at detecting magnesium deficiency. Patients may appear to be normomagnesemic based on their serum magnesium level, yet have an underlying magnesium deficiency. Normal serum magnesium levels vary by laboratory. The normal range of values at Charleston Area Medical Center (CAMC) is 1.6-2.6 mg/dL.
Magnesium replacement depends on the clinical situation and manifestations. In critical conditions such as pre-eclampsia, arrhythmias, and tetany, large doses of IV magnesium are rapidly bolused and often followed by a continuous IV infusion. In asymptomatic patients, magnesium may be replaced by the oral or IV route depending on the clinical situation. The dose required to return patients to the normal magnesium range is variable and replacement may take several doses. Serum magnesium levels are primarily controlled by glomerular filtration and tubular reabsorption at the sites of the Loop of Henle and distal tubule. When faced with an increased filtered load of magnesium, the kidney is capable of increasing its excretion rate. Following intravenous (IV) administration, cellular magnesium uptake is slow and approximately 50% or more of the infused dose is lost due to increased excretion by the kidneys and decreased tubular reabsorption.
The investigators current practice in the Medical and Neuroscience ICUs at CAMC General Hospital is to order 8g of magnesium sulfate for replacement in patients with hypomagnesemia. When IV magnesium sulfate is ordered the pharmacy automatically sets the rate to run at 2g per hour unless otherwise specified. Often times the physician will specify for 8g to be infused over eight hours. The basis of using an extended infusion is that a slower magnesium infusion rate may increase magnesium retention by allowing a longer period of time for magnesium uptake by cells and by decreasing the magnesium load delivered to the kidneys at any given time. As far as the investigators are aware, there have been no studies completed to date that assess the rate of IV magnesium infusion on the magnesium retention rate.
- Conditions
- Primary Hypomagnesemia (Disorder)
- Being tested
- Magnesium Sulfate
- Keywords
- hypomagnesemia, magnesium, magnesium sulfate
- Medical subject headings
- Hypomagnesemia primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Also called magnesium
8 grams over 4 or 8 hours depending on randomization
| Study group | Role | What they receive |
|---|---|---|
| Magnesium 8 grams over 4 hours | Experimental | Not described Receives: Drug: Magnesium Sulfate |
| Magnesium 8 grams over 8 hours | Experimental | Not described Receives: Drug: Magnesium Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of urinary excretion of magnesium after an 8g magnesium sulfate infusion delivered over 4 hours versus 8 hours.
Measured: 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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012
- Study completionDec 2012
Why it stopped: Issues with recruitment. PI decided to terminate study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Primary Hypomagnesemia (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Sarah & Pauline Maier Foundation, Inc.
- Responsible party
- Sponsor
- Investigators
- Jack L DePriest, MD, Principal investigator, WVU School of Medicine/Charleston Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426165
- Sponsor's protocol ID
- 10-10-2271
- Status last verified
- Jan 2014
- First submitted
- 24 Aug 2011
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 3965244Epstein 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.
PubMed 17065651Broeren 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.
PubMed 19920278al-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.
PubMed 7977315Rubeiz 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.
PubMed 8428470McLean 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.
PubMed 8304365Zaloga GP. Interpretation of the serum magnesium level. Chest. 1989 Feb;95(2):257-8. doi: 10.1378/chest.95.2.257. No abstract available.
PubMed 2914469CHESLEY 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.
PubMed 13575537BARKER 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.
PubMed 13796804Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.
PubMed 1244564Agus ZS. Hypomagnesemia. J Am Soc Nephrol. 1999 Jul;10(7):1616-22. doi: 10.1681/ASN.V1071616. No abstract available.
PubMed 10405219
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium Sulfate Infusion Rate on Magnesium Retention in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01426165
- Acronym / sponsor ID
- 10-10-2271
- Conditions
- Primary Hypomagnesemia (Disorder)
- Keywords
- hypomagnesemia, magnesium, magnesium sulfate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Issues with recruitment. PI decided to terminate study
- Enrolment
- 5 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Collaborators
- Sarah & Pauline Maier Foundation, Inc.
- Study start
- Apr 2011 (actual)
- Primary completion
- Apr 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 31 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hypomagnesemia is a common electrolyte disturbance that affects up to 65% of intensive care unit (ICU) patients with normal renal function. Causes of hypomagnesemia are attributed to either gastrointestinal (secretory loss, impaired absorption or reabsorption, acute pancreatitis) or renal losses (alcohol, hypercalcemia, volume expansion, loop or thiazide diuretics, nephrotoxic medications, renal tubular dysfunction, inborn disorders). Consequences of magnesium deficiency are not benign and may include neuromuscular and neurologic dysfunction, cardiac arrhythmias and concomitant electrolyte abnormalities including hypokalemia and hypocalcemia. Hypomagnesemia has been associated with a significantly greater mortality rate in critically ill medical patients compared to normomagnesemic patients. In a study conducted by Rubeiz et al, 46% (17/37) of hypomagnesemic patients in the medical ICU died compared to 25% (37/147) of normomagnesemic patients (p < 0.05).
It can be difficult to assess patients for hypomagnesemia because of the unreliable relationship between serum and tissue magnesium levels. Approximately 1% of total body magnesium is found in the extracellular fluid while the remaining 99% is distributed among the bones, muscles, and soft tissues. Approximately 60% of serum magnesium is free ions; 33% is bound to proteins and 7% is complexed with anions. The most simple and commonly used test to diagnose hypomagnesemia is the total serum magnesium level which reflects free magnesium along with complexed and protein bound magnesium. The serum magnesium level, however, is not always accurate at detecting magnesium deficiency. Patients may appear to be normomagnesemic based on their serum magnesium level, yet have an underlying magnesium deficiency. Normal serum magnesium levels vary by laboratory. The normal range of values at Charleston Area Medical Center (CAMC) is 1.6-2.6 mg/dL.
Magnesium replacement depends on the clinical situation and manifestations. In critical conditions such as pre-eclampsia, arrhythmias, and tetany, large doses of IV magnesium are rapidly bolused and often followed by a continuous IV infusion. In asymptomatic patients, magnesium may be replaced by the oral or IV route depending on the clinical situation. The dose required to return patients to the normal magnesium range is variable and replacement may take several doses. Serum magnesium levels are primarily controlled by glomerular filtration and tubular reabsorption at the sites of the Loop of Henle and distal tubule. When faced with an increased filtered load of magnesium, the kidney is capable of increasing its excretion rate. Following intravenous (IV) administration, cellular magnesium uptake is slow and approximately 50% or more of the infused dose is lost due to increased excretion by the kidneys and decreased tubular reabsorption.
The investigators current practice in the Medical and Neuroscience ICUs at CAMC General Hospital is to order 8g of magnesium sulfate for replacement in patients with hypomagnesemia. When IV magnesium sulfate is ordered the pharmacy automatically sets the rate to run at 2g per hour unless otherwise specified. Often times the physician will specify for 8g to be infused over eight hours. The basis of using an extended infusion is that a slower magnesium infusion rate may increase magnesium retention by allowing a longer period of time for magnesium uptake by cells and by decreasing the magnesium load delivered to the kidneys at any given time. As far as the investigators are aware, there have been no studies completed to date that assess the rate of IV magnesium infusion on the magnesium retention rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium 8 grams over 4 hours | Experimental | Drug: Magnesium Sulfate |
| Magnesium 8 grams over 8 hours | Experimental | Drug: Magnesium Sulfate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium SulfateAlso: magnesium8 grams over 4 or 8 hours depending on randomization | Drug | Magnesium 8 grams over 4 hours, Magnesium 8 grams over 8 hours |
Primary outcome
Amount of urinary excretion of magnesium after an 8g magnesium sulfate infusion delivered over 4 hours versus 8 hours.
Time frame: 24 hours
1 secondary outcome
Mean change in the serum magnesium level after an 8 gm magnesium sulfate infusion delivered over 4 hours and 8 hours
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Issues with recruitment. PI decided to terminate study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 3965244Ryzen 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.
- Background: PubMed 17065651Epstein 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.
- Background: PubMed 19920278Broeren 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.
- Background: PubMed 7977315al-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.
- Background: PubMed 8428470Rubeiz 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.
- Background: PubMed 8304365McLean 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.
- Background: PubMed 2914469Zaloga GP. Interpretation of the serum magnesium level. Chest. 1989 Feb;95(2):257-8. doi: 10.1378/chest.95.2.257. No abstract available.
- Background: PubMed 13575537CHESLEY 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.
- Background: PubMed 13796804BARKER 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.
- Background: PubMed 1244564Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.
- Background: PubMed 10405219Agus ZS. Hypomagnesemia. J Am Soc Nephrol. 1999 Jul;10(7):1616-22. doi: 10.1681/ASN.V1071616. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack L DePriest, MD principal investigator
WVU School of Medicine/Charleston Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Sulfate in people with Primary Hypomagnesemia (Disorder), run by CAMC Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Issues with recruitment. PI decided to terminate study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of urinary excretion of magnesium after an 8g magnesium sulfate infusion delivered over 4 hours versus 8 hours. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01426165, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.