- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01617798
Stop Hypernatremia, Use Metolazone, for Aggressive, Controlled, Effective Diuresis (SHUM)
Stop Hypernatremia, Use Metolazone for Aggressive, Controlled, Effective Diuresis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Mechanical ventilation is a mainstay of Intensive Care. Weaning from mechanical ventilation remains a significant issue in Intensive Care Unit (ICU) care worldwide. It is well established that a strategy of diuresis with negative fluid balance shortens the duration of mechanical ventilation in both acute lung injury and cardiogenic pulmonary edema patients. Despite publication of at least one formalized but complex evidence-based conservative fluid strategy, there is no practical, uniformly implemented protocol for setting or achieving volume status targets. The default approach at many hospitals involves using ad hoc doses (either intermittent or continuous) of a loop diuretic (usually furosemide) with instructions to monitor fluid balance and follow electrolytes in an attempt to reach arbitrary target volume diuresis. Moreover, there are barriers to achieving any particular target, including pre-existing renal failure/diuretic resistance, diuretic-induced creatinine elevation, acquired diuretic resistance, hypotension from volume loss, and electrolyte derangements including hypokalemia and hypernatremia. Strategies exist for preventing or treating the above complications but there is presently no accepted standard for preventing or treating diuretic-induced hypernatremia. In fact, the standard current intervention is to replace the free water deficit that may be induced by the loop diuretic, while simultaneously perpetuating the free water deficit by continuing to administer the causative loop diuretic. This approach is circular and does not effectuate the desired negative fluid balance. We will address the lack of an accepted prevention strategy using a randomized controlled clinical trial in ICU patients with the following specific aims:
- Conduct a randomized, pilot trial of standard versus metolazone supplemented diuresis in ICU patients with the primary outcome of improved negative fluid balance.
- Assess secondary outcomes including time to extubation, exacerbation of renal failure, and incidence of electrolyte derrangements in the treatment and control arms.
- Track whether initial hypernatremia within the control group is a risk factor for poor diuresis with furosemide, and whether it delays extubation.
The anticipated benefits of our proposed intervention involve fundamental ICU and patient care quality measures: avoiding the pitfalls of hypernatremia and diuretic resistance should lead to more effective diuresis, which should in turn lead to a more negative fluid balance, earlier liberation from the ventilator, and a shorter length of stay in the ICU.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health Sciences University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ICU patients who are intubated and slated for diuresis in anticipation of extubation.
- Patients must be hypernatremic (Na > 140 mEq/L) at the time diuresis is initiated or become hypernatremic over the course of receiving loop diuretics in anticipation of extubation.
- GFR > 30 ml/min [as calculated by the MedCalc MDRD formula {GFR = 170 x PCr - 0.999 x Age - 0.176 x BUN - 0.170 x Albumin0.318 x 0.762 (for women) x 1.180 (for blacks)} ]
Exclusion Criteria:
- History of allergy to furosemide or any thiazide diuretic
- Inability to place enteral access
- Moribund status
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control-- furosemide (lasix) only
Control arm receives standard of care diuresis with furosemide(lasix)only. The treatment team will decide the dosing of furosemide (lasix). No actual placebo is administered. |
Control arm will receive furosemide as monotherapy for diuresis
Other Names:
|
Active Comparator: Study Arm
Study arm receives evolving standard of care diuresis with furosemide and metolazone.
|
Patients in the Study Arm will receive supplemental diuresis with metolazone 2.5 mg per dobhoff tube twice daily, in addition to furosemide as the primary team sees fit.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fluid balance
Time Frame: 24, 36, 48, and 72 hours after either protocol is initiated
|
Differences in fluid balance (total net liters negative from the time diuresis is initiated) between the study group and control group at the following intervals: 24, 36, 48, and 72 hours after either protocol is initiated.
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24, 36, 48, and 72 hours after either protocol is initiated
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum sodium
Time Frame: Continuous for 72 hours
|
Number patients whose Na remains below 145 (meq/L) during the period of diuresis; versus the number of patients whose sodium exceeds 145 (meq/L) and require free water replacement.
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Continuous for 72 hours
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Hyponatremia
Time Frame: Continuous for up to 72 hours
|
Number of patients who develop hyponatremia (Na < 136 meq/L)
|
Continuous for up to 72 hours
|
Time to extubation
Time Frame: Unitl the patient is actually extubated, undergoes tracheostomy, or expires.
|
Time in hours from initiation of protocol to extubation (difference between study group and control group
|
Unitl the patient is actually extubated, undergoes tracheostomy, or expires.
|
Acute Kidney Injury
Time Frame: Continuous for the first 72 hours
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Number of patients who develop acute kidney injury (increase in creatinine by more than 25%)
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Continuous for the first 72 hours
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Collaborators and Investigators
Investigators
- Principal Investigator: David Steiger, JD MD, Oregon Health and Science University
- Principal Investigator: Dan Hagg, MS MD, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Water-Electrolyte Imbalance
- Respiratory Insufficiency
- Hypernatremia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Sodium Chloride Symporter Inhibitors
- Sodium Potassium Chloride Symporter Inhibitors
- Furosemide
- Metolazone
Other Study ID Numbers
- IRB00007857
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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