Recruiting

Fluid Management

Sponsor:

Intermountain Health Care, Inc.

Code:

NCT02892799

Conditions

Respiratory Distress Syndrome, Adult

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NICOM-Guided Diuresis

Standard of Care

Study Details

Brief summary:

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.

Conditions

Respiratory Distress Syndrome, Adult

Study ID

NCT02892799

Start date

Nov 12, 2015

Status verified date

Apr, 2019

Completion date

Dec, 2020

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • ≥18 years of age
  • Acute respiratory failure (must meet ONE of the following)

  • Receipt of mechanical ventilation
  • Receipt of non-invasive ventilation via BIPAP or CPAP, used for an indication other than sleep apnea
  • Receipt of high flow nasal cannula oxygenation with FiO2 > .4 and a flow rate > 30 LPM
  • Increased total body fluid volume (any of the following)

  • > 1 kg increased weight gain (compared to admission)
  • > 1 L positive fluid balance (compared to admission)
  • Bedside clinician determination

Exclusion Criteria

  • Known pregnancy (a negative pregnancy test is required for women of child-bearing potential)
  • Dialysis dependence, at the time of enrollment
  • Chronic ventilator dependence, prior to admission
  • Intubation for airway protection (solely for a surgical procedure) or upper airway obstruction
  • Neuromuscular disease that impairs the ability to ventilate spontaneously, such as C5 or higher spinal cord injury, amyotrophic lateral sclerosis, Guillain-Barré Syndrome, and myasthenia gravis
  • Solid organ transplantation or bone marrow transplantation
  • Vasculitis with diffuse alveolar hemorrhage
  • Severe chronic liver disease (Child-Pugh Score 10-15)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard of Care

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.

experimental: NICOM-Guided Diuresis

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.

Interventions

NICOM-Guided Diuresis

NICOM-based assessment of PLR-induced change in cardiac index

Standard of Care

Primary outcome measure

  • Composite incidence of new acute kidney injury (AKI), new hypotension (mean arterial blood pressure < 60 following diuresis), and new shock (SOFA (Sequential Organ Failure Assessment) score) [ Time Frame: Admission to ICU through discharge from ICU ]
  • 7-day cumulative fluid balance [ Time Frame: Days 1 to 7 ]
  • Correlation of non-invasive NICOM derived cardiac parameters with incidence of new acute kidney injury (AKI), new hypotension, and new shock [ Time Frame: Admission to ICU through discharge from ICU ]

Central Contacts and Locations

Central contacts

Michael Lanspa, MD

801-408-5060michael.lanspa@imail.org

Valerie Aston, MBA, RT

(801) 507-4606Valerie.Aston@imail.org

Locations

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

Michael Lanspa, MD

801-507-6556

Principal Investigator:

Michael Lanspa, MD

More Information

Sponsor

Intermountain Health Care, Inc.

Last update posted

Apr 8, 2019

Last verified

Apr, 2019

Keywords

  • NICOM device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Intermountain Health Care, Inc. on 2019-04-08.