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NICOM-Guided Diuresis for Respiratory Distress Syndrome (DECAF Trial)

N/A
Waitlist Available
Led By Michael Lanspa, MD
Research Sponsored by Intermountain Health Care, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up admission to icu through discharge from icu
Awards & highlights

DECAF Trial 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.

Eligible Conditions
  • Respiratory Distress Syndrome

DECAF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~admission to icu to day 28 after admission to icu
This trial's timeline: 3 weeks for screening, Varies for treatment, and admission to icu to day 28 after admission to icu for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
7-day cumulative fluid balance
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)
Correlation of non-invasive NICOM derived cardiac parameters with incidence of new acute kidney injury (AKI), new hypotension, and new shock
Secondary outcome measures
60-day mortality
ICU-free days to day 28 (days alive and out of the ICU)
Incidence of new kidney injury
+2 more

DECAF Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NICOM-Guided DiuresisExperimental Treatment1 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 CareActive Control1 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.

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Who is running the clinical trial?

Intermountain Health Care, Inc.Lead Sponsor
137 Previous Clinical Trials
1,963,010 Total Patients Enrolled
5 Trials studying Respiratory Distress Syndrome
9,338 Patients Enrolled for Respiratory Distress Syndrome
Michael Lanspa, MDPrincipal InvestigatorIntermountain Health Care, Inc.
2 Previous Clinical Trials
780 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Non-invasive Fluid Management
Michael Lanspa 2015. "Non-invasive Fluid Management". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02892799.
~11 spots leftby May 2025
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