Ignite Creation Date:
2024-05-06 @ 12:58 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01700998
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2012-10-01
Brief Title:
Magnesium Replacement Therapy to Prevent Acute Renal Failure in Critically Ill Patients
Sponsor:
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Organization:
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Study Overview
Official Title:
Randomized Trial of Magnesium Replacement Therapy to Prevent Acute Renal Failure in Hypomagnesemic Critically Ill Patients
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute renal failure ARF is a serious and common complication in hospitalized patients occurring in more than 25 of intensive care unit ICU patients Hypomagnesemia is a common disorder occurring in approximately 12 of hospitalized patients with an incidence of 60 in ICU patients The majority of those patients have are asymptomatic hypomagnesemia and patients with mild hypomagnesemia do not need treatment only the correction of the underlying cause Hypomagnesemia potentiates postischemic renal failure in rats and is associated in humans with acute renal failure To date there is no study that demonstrated a benefit of maintain normal levels of magnesium in the incidence of ARF in critically ill patients Thus we suggest that a treatment aimed to maintain normal magnesium levels during ICU stay can decrease the incidence of ARF We will perform a randomized clinical trial that will include all patients admitted to an ICU that develop hypomagnesemia It will be excluded from the study patients younger than 18 years participants from other studies pregnant women patients with creatinine greater than or equal to 35 mg dl or on dialysis patients who used intravenous contrast for radiological studies patients weighing less than 40kg suffering from advanced malignant disease with severe hypomagnesemia serum magnesium less than or equal to 11 mg dl with a diagnosis of Torsades de Pointes or symptomatic hypomagnesemia prior to randomization Patients included in the study will be randomized to one of the following groups placebo saline solution 09 or 50 Magnesium Sulfate Patients will receive an administration of 48 mEq Magnesium diluted in 250 ml saline 09 for 24 hours in an infusion rate of 104 ml hr Therapy will be continued for 3 days and repeated during ICU stay to maintain magnesium levels in the normal range Placebo group will receive exactly the same infusion only with saline administration The therapy will be discontinued if the patient has hypermagnesemia or signs of magnesium intoxication The main outcome measurement will be the occurrence of ARF during ICU stay
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None