Non-invasive Fluid Management

Not Applicable

• Conditions: Respiratory Distress Syndrome, Adult

• Registration Number: NCT02892799
• Lead Sponsor: Intermountain Health Care, Inc.

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.

Study Timeline

• Study Start: 2015-11-12
• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-08
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-08
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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)	Admission to ICU through discharge from ICU	Primary predictor is diuresis treatment protocol arm
7-day cumulative fluid balance	Days 1 to 7	Primary predictor is diuresis treatment protocol arm
Correlation of non-invasive NICOM derived cardiac parameters with incidence of new acute kidney injury (AKI), new hypotension, and new shock	Admission to ICU through discharge from ICU	Primary predictor is NICOM-derived percent (%) change in stroke volume index

Secondary Outcome Measures

Name	Time	Method
Incidence of new kidney injury	Days 1-7	New kidney injury is defined by an increase in serum creatinine, adjusted for a fluid balance of 50%, or an absolute increase in serum creatinine of more than 0.3-mg/dL over a 48-hour window during study 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

Trial Locations

Locations (1)

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States