Respiratory Failure Clinical Trial
— SHUMOfficial title:
Stop Hypernatremia, Use Metolazone for Aggressive, Controlled, Effective Diuresis
NCT number | NCT01617798 |
Other study ID # | IRB00007857 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2012 |
Est. completion date | June 2013 |
Verified date | June 2019 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health Sciences University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 24, 36, 48, and 72 hours after either protocol is initiated | |
Secondary | 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. | Continuous for 72 hours | |
Secondary | Hyponatremia | Number of patients who develop hyponatremia (Na < 136 meq/L) | Continuous for up to 72 hours | |
Secondary | Time to extubation | 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. | |
Secondary | Acute Kidney Injury | Number of patients who develop acute kidney injury (increase in creatinine by more than 25%) | Continuous for the first 72 hours |
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