Clinical trial NCT02892799: Non-invasive Fluid Management
Official title: Non-invasive Fluid Management in Critically Ill Patients With ARDS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Distress Syndrome, Adult
Keywords: NICOM device
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: BACKGROUND:

Negative fluid balance in acute respiratory distress syndrome (ARDS) has been shown to improve intensive care unit (ICU) length of stay and ventilator-free days. Although protocols exist for fluid management, all require invasive hemodynamic monitoring. Despite the large evidence base supporting the use of invasive monitoring, the majority of ARDS patients are now managed without invasive central lines. A non-invasive protocol for managing fluid status in patients with ARDS has not been rigorously implemented nor studied within a randomized controlled trial.

OBJECTIVE:

The study objective is to compare a novel non-invasive parameter-guided protocol for fluid management to usual care. The specific aims are: 1) to compare the incidence of new or worsening renal failure, the incidence of new or worsening shock, and the incidence of new or worsening non-shock hypotension; 2) to compare the relative effectiveness of the 2 treatment groups as assessed by cumulative fluid balance over 7 days; 3) to determine if the non-invasive protocol increases the number of ventilator-free days and ICU-free days; and further, to evaluate if it decreases 60-day mortality; and 4) to document the clinical instances where treatment digression between the 2 groups occurs.

STUDY DESIGN:

This study is a single-blinded, randomized control trial, comparing 1 treatment arm to usual care. We will treat patients with severe hypoxemic respiratory failure (including ARDS) for 7 consecutive days. Their post-study course will be monitored for a period of 60 days or until death. Patients who are randomized to the intervention group will receive fluid management strategies that are dictated by non-invasively derived (via the "NICOM" device) surrogates of cardiac preload and output. Patients who are randomized to the control group will receive standard-of-care "best practice" fluid management, as dictated by the treating physician.

Eligibility criteria: 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)

Primary outcomes:
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)
timeFrame: Admission to ICU through discharge from ICU
measure: 7-day cumulative fluid balance
timeFrame: Days 1 to 7
measure: Correlation of non-invasive NICOM derived cardiac parameters with incidence of new acute kidney injury (AKI), new hypotension, and new shock
timeFrame: Admission to ICU through discharge from ICU
Secondary outcomes:
measure: Incidence of new kidney injury
timeFrame: Days 1-7
measure: Ventilator-free days to day 28 (days alive and free from mechanical ventilation)
timeFrame: Admission to ICU to day 28 after admission to ICU
measure: ICU-free days to day 28 (days alive and out of the ICU)
timeFrame: Admission to ICU to day 28 after admission to ICU
measure: 60-day mortality
timeFrame: Admission to ICU to 60 days after admission to ICU
measure: Incidence of new shock between the treatment arms (NICOM-guided diuresis, usual care)
timeFrame: Admission to ICU through discharge from ICU
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Michael Lanspa, MD
role: PRINCIPAL_INVESTIGATOR
References: