Non-invasive Fluid Management

NCT02892799 | Unknown DMC FDA Device

• 1 other identifier: 1050087
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

NICOM device

Outcome Measures

Primary Outcomes (3)

• 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)

  Primary predictor is diuresis treatment protocol arm

  Admission to ICU through discharge from ICU

• 7-day cumulative fluid balance

  Primary predictor is diuresis treatment protocol arm

  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

  Primary predictor is NICOM-derived percent (%) change in stroke volume index

  Admission to ICU through discharge from ICU

Secondary Outcomes (5)

• Incidence of new kidney injury

  Days 1-7

• Ventilator-free days to day 28 (days alive and free from mechanical ventilation)

  Admission to ICU to day 28 after admission to ICU

• ICU-free days to day 28 (days alive and out of the ICU)

  Admission to ICU to day 28 after admission to ICU

• 60-day mortality

  Admission to ICU to 60 days after admission to ICU

• Incidence of new shock between the treatment arms (NICOM-guided diuresis, usual care)

  Admission to ICU through discharge from ICU

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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.

Other: Standard of Care

NICOM-Guided Diuresis

EXPERIMENTAL

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.

Other: NICOM-Guided Diuresis

Interventions

NICOM-Guided Diuresis OTHER

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

NICOM-Guided Diuresis

Standard of Care OTHER

Standard of Care

Eligibility Criteria

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

You may qualify if:

• ≥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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84107, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Michael Lanspa, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Lanspa, MD

CONTACT

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

Valerie Aston, MBA, RT

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Assistant Professor

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 8, 2016
• Study Start: November 12, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 8, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)