Respiratory Distress Syndrome, AdultDECAFNCT02892799
Non-invasive Fluid Management
A study testing NICOM-Guided Diuresis in people with Respiratory Distress Syndrome, Adult, run by Intermountain Health Care, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- NICOM-Guided Diuresis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2015to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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)
Show all 9Show fewer
- > 1 kg increased weight gain (compared to admission)
- > 1 L positive fluid balance (compared to admission)
- Bedside clinician determination
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
Michael Lanspa, MD, 801-507-6556
Michael Lanspa, MD
About this study
Official title: Non-invasive Fluid Management in Critically Ill Patients With ARDS
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.
Read the 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.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- NICOM-Guided Diuresis, Standard of Care
- Keywords
- NICOM device
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NICOM-Guided DiuresisOther
NICOM-based assessment of PLR-induced change in cardiac index
Standard of CareOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: NICOM-Guided Diuresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Admission to ICU through discharge from ICU
7-day cumulative fluid balance
Primary predictor is diuresis treatment protocol arm
Measured: 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
Measured: Admission to ICU through discharge from ICU
Secondary outcomes (5)
Incidence of new kidney injury
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
Measured: Days 1-7
Ventilator-free days to day 28 (days alive and free from mechanical ventilation)
Measured: Admission to ICU to day 28 after admission to ICU
ICU-free days to day 28 (days alive and out of the ICU)
Measured: Admission to ICU to day 28 after admission to ICU
60-day mortality
Measured: Admission to ICU to 60 days after admission to ICU
Incidence of new shock between the treatment arms (NICOM-guided diuresis, usual care)
Measured: Admission to ICU through discharge from ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start12 Nov 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Lanspa, Intermountain Health Care, Inc.
- Investigators
- Michael Lanspa, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892799
- Sponsor's protocol ID
- 1050087
- Acronym
- DECAF
- Status last verified
- Apr 2019
- First submitted
- 2 Sep 2016
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Fluid Management in Critically Ill Patients With ARDS
- ClinicalTrials.gov ID
- NCT02892799
- Acronym / sponsor ID
- DECAF / 1050087
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- NICOM device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 12 Nov 2015 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of CarePatients 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. |
| NICOM-Guided Diuresis | Experimental | Other: NICOM-Guided DiuresisWithin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥18 years of age
- Acute respiratory failure (must meet ONE of the following)
- Increased total body fluid volume (any of the following)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NICOM-Guided DiuresisNICOM-based assessment of PLR-induced change in cardiac index | Other | NICOM-Guided Diuresis |
| Standard of Care | Other | Standard of Care |
Primary outcome
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
Primary predictor is diuresis treatment protocol arm
7-day cumulative fluid balance
Time frame: 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
Time frame: Admission to ICU through discharge from ICU
Primary predictor is NICOM-derived percent (%) change in stroke volume index
5 secondary outcomes
Incidence of new kidney injury
Time frame: Days 1-7
Ventilator-free days to day 28 (days alive and free from mechanical ventilation)
Time frame: Admission to ICU to day 28 after admission to ICU
ICU-free days to day 28 (days alive and out of the ICU)
Time frame: Admission to ICU to day 28 after admission to ICU
60-day mortality
Time frame: Admission to ICU to 60 days after admission to ICU
Incidence of new shock between the treatment arms (NICOM-guided diuresis, usual care)
Time frame: Admission to ICU through discharge from ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Lanspa, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NICOM-Guided Diuresis in people with Respiratory Distress Syndrome, Adult, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Lanspa, MD (801-408-5060, michael.lanspa@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.