Stop Hypernatremia, Use Metolazone, for Aggressive, Controlled, Effective Diuresis (SHUM)
|ClinicalTrials.gov Identifier: NCT01617798|
Recruitment Status : Unknown
Verified June 2012 by David Steiger, JD MD, Oregon Health and Science University.
Recruitment status was: Recruiting
First Posted : June 12, 2012
Last Update Posted : June 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Failure Volume Overload Hypernatremia||Drug: Supplemental metolazone diuresis Drug: Placebo Comparator: Control-- furosemide (lasix) only||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stop Hypernatremia, Use Metolazone for Aggressive, Controlled, Effective Diuresis|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||June 2013|
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.
Drug: Placebo Comparator: Control-- furosemide (lasix) only
Control arm will receive furosemide as monotherapy for diuresis
Other Name: furosemide, lasix, metolazone
Active Comparator: Study Arm
Study arm receives evolving standard of care diuresis with furosemide and metolazone.
Drug: Supplemental metolazone diuresis
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 Name: furosemide, lasix
- 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.
- 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.
- Hyponatremia [ Time Frame: Continuous for up to 72 hours ]Number of patients who develop hyponatremia (Na < 136 meq/L)
- 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
- Acute Kidney Injury [ Time Frame: Continuous for the first 72 hours ]Number of patients who develop acute kidney injury (increase in creatinine by more than 25%)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617798
|Contact: James Case, MD||5034949000||Caseja@ohsu.edu|
|United States, Oregon|
|Oregon Health Sciences University||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Dan Hagg, MD|
|Principal Investigator: David Steiger, JD, MD|
|Principal Investigator: Dan Hagg, MS, MD|
|Principal Investigator:||David Steiger, JD MD||Oregon Health and Science University|
|Principal Investigator:||Dan Hagg, MS MD||Oregon Health and Science University|