ClinicalTrials.gg
WithdrawnNCT01617798SHUMUpdated Jun 6, 2019

Stop Hypernatremia, Use Metolazone, for Aggressive, Controlled, Effective Diuresis

An interventional study of Supplemental metolazone diuresis and Placebo Comparator: Control-- furosemide (lasix) only in Respiratory Failure, Volume Overload and Hypernatremia, sponsored by Oregon Health and Science University. Withdrawn at 1 site in United States. Per ClinicalTrials.gov, last updated 2019-06-06.

Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Investigator departed organization
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Sex
All
01

Study summary

Patients who are on mechanical ventilation in an intensive care unit often require diursis as part of their pre-extubation regimen. The drug of choice for diuresis has traditionally been furosemide. However, this drug cause hypernatremia (a rise in serum sodium) in a significant proportion of patients. Hypernatremia is traditionally treated by providing free water supplementation to the patient. This strategy creates a vicious and unproductive cycle of giving free water, and then diuresing it off. We propose a strategy for breaking this cycle by using a second diuretic-- metolazone-- which has a tendency to rid the body of more sodium, thereby minimizing hypernatremia.

Read the 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:

  1. Conduct a randomized, pilot trial of standard versus metolazone supplemented diuresis in ICU patients with the primary outcome of improved negative fluid balance.
  2. Assess secondary outcomes including time to extubation, exacerbation of renal failure, and incidence of electrolyte derrangements in the treatment and control arms.
  3. 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.

02

Conditions studied

  • Respiratory Failure
  • Volume Overload
  • Hypernatremia
03

In context

Respiratory Insufficiency

1,675 studies on the registry are indexed under Respiratory Insufficiency; 300 are open to participants now.

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Lead sponsor

Oregon Health and Science University is the lead sponsor of 694 studies on the registry; 133 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 39 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • History of allergy to furosemide or any thiazide diuretic
  • Inability to place enteral access
  • Moribund status
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

  • Active comparator
    Study Arm

    Study arm receives evolving standard of care diuresis with furosemide and metolazone.

    Drug: Supplemental metolazone diuresis

Interventions

  • DrugSupplemental 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.

    Also known as: furosemide, lasix

  • DrugPlacebo Comparator: Control-- furosemide (lasix) only

    Control arm will receive furosemide as monotherapy for diuresis

    Also known as: furosemide, lasix, metolazone

06

What researchers measure

Primary outcomes

  1. Fluid balance

    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.

    Time frame: 24, 36, 48, and 72 hours after either protocol is initiated

Secondary outcomes

  1. Serum sodium

    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.

    Time frame: Continuous for 72 hours

  2. Hyponatremia

    Number of patients who develop hyponatremia (Na \< 136 meq/L)

    Time frame: Continuous for up to 72 hours

  3. Time to extubation

    Time in hours from initiation of protocol to extubation (difference between study group and control group

    Time frame: Unitl the patient is actually extubated, undergoes tracheostomy, or expires.

  4. Acute Kidney Injury

    Number of patients who develop acute kidney injury (increase in creatinine by more than 25%)

    Time frame: Continuous for the first 72 hours

07

Study locations

1 site
  • Oregon Health Sciences University
    Portland, Oregon 97239, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01617798
Responsible party
Jeffrey Gold (Professor of Medicine, Oregon Health and Science University) — Principal investigator
First posted
Jun 12, 2012
Start date
Jun 2012
Primary completion
Jun 2013 (estimated)
Completion
Jun 2013 (estimated)
Last update
Jun 6, 2019

Study contacts

David Steiger, JD MD
principal investigator · Oregon Health and Science University
Dan Hagg, MS MD
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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