Non-invasive Fluid Management

(DECAF Trial)

Overseen by Michael Lanspa, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Intermountain Health Care, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

For patients with a condition called acute respiratory distress syndrome (ARDS), managing their fluid levels to achieve a negative balance helps to improve their outcomes. In the past, patients' fluid levels were monitored with central lines placed into the bloodstream. However, most patients are now managed without central lines. A device called a NICOM (noninvasive cardiac output monitor) which monitors patients' heart function, using a few patches which are attached to their chest, may be useful in managing fluid levels without central lines. This study will compare the fluid balance in patients who are managed with typical care to the fluid balance in patients who are managed with the NICOM device.

Research Team

Michael Lanspa, MD

Principal Investigator

Intermountain Health Care, Inc.

Eligibility Criteria

Inclusion Criteria

≥18 years of age

Acute respiratory failure (must meet ONE of the following)

Receipt of mechanical ventilation

Treatment Details

Interventions

• NICOM-Guided Diuresis (Procedure)
• Standard of Care (Other)

Participant Groups

Group I: NICOM-Guided Diuresis Experimental Treatment 1 Intervention

Within 4 hours, patients will have their blood pressure obtained, a NICOM-based assessment of PLR (passive leg raise)-induced change in cardiac index, hourly urinary output, and quantization of the total input and output from the beginning of the morning shift (7 am). This will allow determination of the fluid goal over the next 4 hours. Patients will receive furosemide to achieve the goal fluid balance, if needed as described in the accompanying protocol. Monitoring of electrolytes and renal function will be at the discretion of the treating physician. Following the initial evaluation, at set times spaced every 4 hours apart, patients will have an ongoing evaluation of the day's fluid balance, hourly urinary output, and PLR/NICOM values. This diuresis protocol will continue for a total of seven 24-hour periods or until the primary means of oxygenation/ventilation has been withdrawn, whichever occurs first. Patients will be followed for a total of 60 days to evaluate outcome data.

Group II: Standard of Care Active Control 1 Intervention

Patients randomized to the usual care arm will be treated almost the same as if they do not enroll in the study. They will be managed in accordance with best ICU (intensive care unit) practices, with treatment decisions made by the treating team. Often this will include blood draws (often 2 teaspoons once or twice per day, but sometimes exceeding this), assessments of cardiac function, assessments of fluid status, and other measures as dictated by the presenting illness (this is broad and will include antibiotics, diuretics, cardiac medications, ventilator and oxygen management, etc.). Patients in the usual care arm will not have diuresis managed by NICOM.

Who Is Running the Clinical Trial?

Intermountain Health Care, Inc.

Lead Sponsor

Trials

142

Recruited

1,965,000+

Brent James

Intermountain Health Care, Inc.

Chief Medical Officer since 2010

MD from University of Utah

Rob Allen

Intermountain Health Care, Inc.

Chief Executive Officer since 2022

Bachelor's degree in Business Administration