Respiratory FailureSHUMNCT01617798
Stop Hypernatremia, Use Metolazone, for Aggressive, Controlled, Effective Diuresis
A study testing Supplemental metolazone diuresis in people with Respiratory Failure and Volume Overload, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Failure, Volume Overload, Hypernatremia
- What is being tested?
- Supplemental metolazone diuresis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)} ]
Who cannot join
- History of allergy to furosemide or any thiazide diuretic
- Inability to place enteral access
- Moribund status
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health Sciences University
Portland, Oregon, 97239
About this study
Official title: Stop Hypernatremia, Use Metolazone for Aggressive, Controlled, Effective Diuresis
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:
- 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.
- Conditions
- Respiratory Failure, Volume Overload, Hypernatremia
- Being tested
- Supplemental metolazone diuresis, Placebo Comparator: Control-- furosemide (lasix) only
- Medical subject headings
- Respiratory Insufficiency, Edema, Hypernatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental metolazone diuresisDrug
Also called furosemide, lasix
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.
Placebo Comparator: Control-- furosemide (lasix) onlyDrug
Also called furosemide, lasix, metolazone
Control arm will receive furosemide as monotherapy for diuresis
| Study group | Role | What they receive |
|---|---|---|
| Control-- furosemide (lasix) only | Placebo comparator | 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. Receives: Drug: Placebo Comparator: Control-- furosemide (lasix) only |
| Study Arm | Active comparator | Study arm receives evolving standard of care diuresis with furosemide and metolazone. Receives: Drug: Supplemental metolazone diuresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24, 36, 48, and 72 hours after either protocol is initiated
Secondary outcomes (4)
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.
Measured: Continuous for 72 hours
Hyponatremia
Number of patients who develop hyponatremia (Na < 136 meq/L)
Measured: Continuous for up to 72 hours
Time to extubation
Time in hours from initiation of protocol to extubation (difference between study group and control group
Measured: Unitl the patient is actually extubated, undergoes tracheostomy, or expires.
Acute Kidney Injury
Number of patients who develop acute kidney injury (increase in creatinine by more than 25%)
Measured: Continuous for the first 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Why it stopped: Investigator departed organization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Gold, Oregon Health and Science University
- Investigators
- David Steiger, JD MD, Principal investigator, Oregon Health and Science UniversityDan Hagg, MS MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617798
- Sponsor's protocol ID
- IRB00007857
- Acronym
- SHUM
- Status last verified
- Jun 2019
- First submitted
- 1 Jun 2012
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stop Hypernatremia, Use Metolazone for Aggressive, Controlled, Effective Diuresis
- ClinicalTrials.gov ID
- NCT01617798
- Acronym / sponsor ID
- SHUM / IRB00007857
- Conditions
- Respiratory Failure, Volume Overload, Hypernatremia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator departed organization
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control-- furosemide (lasix) only | Placebo comparator | Drug: Placebo Comparator: Control-- furosemide (lasix) onlyControl 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. |
| Study Arm | Active comparator | Drug: Supplemental metolazone diuresisStudy arm receives evolving standard of care diuresis with furosemide and metolazone. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)} ]
Key exclusion criteria (3 listed)
- History of allergy to furosemide or any thiazide diuretic
- Inability to place enteral access
- Moribund status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplemental metolazone diuresisAlso: furosemide, lasixPatients 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. | Drug | Study Arm |
| Placebo Comparator: Control-- furosemide (lasix) onlyAlso: furosemide, lasix, metolazoneControl arm will receive furosemide as monotherapy for diuresis | Drug | Control-- furosemide (lasix) only |
Primary outcome
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.
4 secondary outcomes
Serum sodium
Time frame: Continuous for 72 hours
Hyponatremia
Time frame: Continuous for up to 72 hours
Time to extubation
Time frame: Unitl the patient is actually extubated, undergoes tracheostomy, or expires.
Acute Kidney Injury
Time frame: Continuous for the first 72 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Steiger, JD MD principal investigator
Oregon Health and Science University
Dan Hagg, MS MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplemental metolazone diuresis in people with Respiratory Failure and Volume Overload, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid balance (time frame: 24, 36, 48, and 72 hours after either protocol is initiated). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.