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

NCT01617798 | Withdrawn DMC

• 1 other identifier: IRB00007857
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Failure; Volume Overload; Hypernatremia

Outcome Measures

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.

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

Secondary Outcomes (4)

• Serum sodium

  Continuous for 72 hours

• Hyponatremia

  Continuous for up to 72 hours

• Time to extubation

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

• Acute Kidney Injury

  Continuous for the first 72 hours

Study Arms (2)

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.

Drug: Placebo Comparator: Control-- furosemide (lasix) only

Study Arm

ACTIVE COMPARATOR

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

Drug: Supplemental metolazone diuresis

Interventions

Supplemental metolazone diuresis DRUG

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

Study Arm

Placebo Comparator: Control-- furosemide (lasix) only DRUG

Control arm will receive furosemide as monotherapy for diuresis

Also known as: furosemide, lasix, metolazone

Control-- furosemide (lasix) only

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[as calculated by the MedCalc MDRD formula {GFR = 170 x PCr - 0.999 x Age - 0.176 x BUN - 0.170 x Albumin0.318 x 0.762 (for women) x 1.180 (for blacks)} \]

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Edema; Hypernatremia

Interventions

Furosemide; Single Person; Metolazone

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors; Quinazolinones; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• David Steiger, JD MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Dan Hagg, MS MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 1, 2012
• First Posted: June 12, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 6, 2019

Record last verified: 2019-06

Locations

US (1)