Magnesium Replacement Therapy to Prevent Acute Renal Failure in Critically Ill Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Sponsor:
Information provided by (Responsible Party):
Felipe Dal Pizzol, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
ClinicalTrials.gov Identifier:
NCT01700998
First received: October 1, 2012
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

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 3.5 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 1.1 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 0.9%) or 50% Magnesium Sulfate. Patients will receive an administration of 48 mEq Magnesium diluted in 250 ml saline 0.9% for 24 hours in an infusion rate of 10.4 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.


Condition Intervention
Hypomagnesemia
Drug: Magnesium
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Trial of Magnesium Replacement Therapy to Prevent Acute Renal Failure in Hypomagnesemic Critically Ill Patients

Resource links provided by NLM:


Further study details as provided by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude:

Primary Outcome Measures:
  • Incidence of acute renail failure [ Time Frame: During ICU stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of recovery from ARF [ Time Frame: During hospital stay, an expected average of 5 weeks ] [ Designated as safety issue: No ]
  • ICU and hospital length of stay [ Time Frame: Hospital discharge, an expected average of 5 weeks ] [ Designated as safety issue: No ]
  • ICU and hospital mortality [ Time Frame: Hospital discharge, an expected average of 2 (ICU) and 5 (hospital) weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: September 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
250 ml saline 0.9% for 24 hours in an infusion rate solution of 10.4 ml / hr for 3 days repeated during ICU stay if hypomagnesemia occurs.
Drug: Placebo
Experimental: Magnesium
48 mEq Magnesium diluted in 250 ml saline 0.9% for 24 hours in an infusion rate solution of 10.4 ml / hr. Therapy is continued for 3 days and repeated if hypomagnesemia occurs during ICU stay
Drug: Magnesium

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients, clinical or surgical, who signed (or their relatives) the informed consent form, which presented hypomagnesemia (with serum magnesium between 1.2 and 1.8 mg / dL), with no symptoms of hypomagnesemia.

Exclusion Criteria:

  • Patients younger than 18 years, participants from other studies, pregnant women, patients with admission plasma creatinine greater than or equal to 3.5 mg / dl or on dialysis, patients who used intravenous contrast for radiological studies, patients weighing less than 40kg, patients suffering from advanced cancer, patients with severe hypomagnesemia (serum magnesium less than or equal to 1.1 mg / dl), patients with a diagnosis of Torsades de Pointes or patients with symptomatic hypomagnesemia prior to randomization.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700998

Contacts
Contact: Felipe Dal-Pizzol, MD, PhD +55 48 34312539 piz@unesc.net

Locations
Brazil
Hospital Sao Jose Recruiting
Criciuma, SC, Brazil, 88801
Contact: Emilio L Streck, PhD    +55 48 34312578    est@unesc.net   
Principal Investigator: Felipe Dal-Pizzol, MD, PhD         
Sponsors and Collaborators
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Investigators
Study Chair: Cristiane Ritter, MD, PhD UNESC
  More Information

No publications provided

Responsible Party: Felipe Dal Pizzol, MD, PhD, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
ClinicalTrials.gov Identifier: NCT01700998     History of Changes
Other Study ID Numbers: MgICU
Study First Received: October 1, 2012
Last Updated: October 2, 2012
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Critical Illness
Renal Insufficiency
Acute Kidney Injury
Disease Attributes
Pathologic Processes
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014