Diuresis Using Echocardiography, CVP, and FACTT-Lite
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hospital, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/9/2018 |
| Start Date: | July 2016 |
| End Date: | December 2020 |
This is a research study about monitoring diuresis in acute respiratory failure. Often,
patients with respiratory failure have fluid building up in the lungs, which means less
oxygen can reach the blood stream, which deprives the organs of oxygen. Managing the amount
of intravenous fluids is crucial to the treatment of respiratory failure. Diuresis, the
increased formation of urine by the kidney, is one way that fluid balance is maintained.
Previous studies of respiratory failure suggest that diuretic therapy may be beneficial in a
group of patients with Acute Respiratory Distress Syndrome, (ARDS), which is a severe type of
respiratory failure. Although protocols exist for managing fluid status in ARDS, all of them
require invasive monitoring using a central venous catheter. This study will compare central
venous catheter-guided diuresis to ultrasound-guided diuresis. Participants in this study
will be randomized into one of three treatment arms:
- Fluid and Catheter Treatment Trial-lite (FACTT-Lite) diuresis arm
- Echocardiography diuresis arm
- Central venous pressure "CVP" diuresis arm This research study will assess differences
in clinical outcomes, number of ventilator free days, ICU free days, 60 day mortality,
and incidence of acute kidney injury or new shock between the three treatment arms.
patients with respiratory failure have fluid building up in the lungs, which means less
oxygen can reach the blood stream, which deprives the organs of oxygen. Managing the amount
of intravenous fluids is crucial to the treatment of respiratory failure. Diuresis, the
increased formation of urine by the kidney, is one way that fluid balance is maintained.
Previous studies of respiratory failure suggest that diuretic therapy may be beneficial in a
group of patients with Acute Respiratory Distress Syndrome, (ARDS), which is a severe type of
respiratory failure. Although protocols exist for managing fluid status in ARDS, all of them
require invasive monitoring using a central venous catheter. This study will compare central
venous catheter-guided diuresis to ultrasound-guided diuresis. Participants in this study
will be randomized into one of three treatment arms:
- Fluid and Catheter Treatment Trial-lite (FACTT-Lite) diuresis arm
- Echocardiography diuresis arm
- Central venous pressure "CVP" diuresis arm This research study will assess differences
in clinical outcomes, number of ventilator free days, ICU free days, 60 day mortality,
and incidence of acute kidney injury or new shock between the three treatment arms.
The objective of this study is to compare two different central venous catheter guided
protocols for diuresis to an ultrasound guided protocol for diuresis. The specific aims are:
1) to compare the cumulative fluid balance over seven days among the groups; 2) to determine
if the ultrasound protocol increases the number of ventilator free days and ICU-free days;
and if it decreases 60-day mortality, incidence of acute kidney injury, or incidence of new
shock; and if it speeds resolution of pulmonary edema; 3) to document the clinical situations
and specific decisions where catheter guided diuresis and echocardiography guided diuresis
recommend a different management decision.
The study is a randomized control trial, comparing three treatment arms. The investigators
will treat intubated patients from identification of hypoxemic respiratory failure, including
ARDS, with one of three diuresis strategies for seven consecutive days. Their post-study
course will be monitored for a period of 60-days or until death. The patients randomized to
the "FACTT-Lite" guided diuresis arm will be treated using the Fluid and Catheter Treatment
Trial-Lite (FACTT-Lite) protocol and will be used as the control group. The patients
randomized to the echocardiography, or "Echo", diuresis arm will be treated using a protocol
developed for use in this study using daily or twice daily echocardiographic and ultrasound
measurements. The patients randomized to the central venous pressure, or "CVP", arm will be
diuresed using a protocol similar to the "Echo" arm, substituting the central venous pressure
threshold from FACTT-lite. Echocardiographic and catheter based markers of volume status will
be compared following the study.
protocols for diuresis to an ultrasound guided protocol for diuresis. The specific aims are:
1) to compare the cumulative fluid balance over seven days among the groups; 2) to determine
if the ultrasound protocol increases the number of ventilator free days and ICU-free days;
and if it decreases 60-day mortality, incidence of acute kidney injury, or incidence of new
shock; and if it speeds resolution of pulmonary edema; 3) to document the clinical situations
and specific decisions where catheter guided diuresis and echocardiography guided diuresis
recommend a different management decision.
The study is a randomized control trial, comparing three treatment arms. The investigators
will treat intubated patients from identification of hypoxemic respiratory failure, including
ARDS, with one of three diuresis strategies for seven consecutive days. Their post-study
course will be monitored for a period of 60-days or until death. The patients randomized to
the "FACTT-Lite" guided diuresis arm will be treated using the Fluid and Catheter Treatment
Trial-Lite (FACTT-Lite) protocol and will be used as the control group. The patients
randomized to the echocardiography, or "Echo", diuresis arm will be treated using a protocol
developed for use in this study using daily or twice daily echocardiographic and ultrasound
measurements. The patients randomized to the central venous pressure, or "CVP", arm will be
diuresed using a protocol similar to the "Echo" arm, substituting the central venous pressure
threshold from FACTT-lite. Echocardiographic and catheter based markers of volume status will
be compared following the study.
Inclusion Criteria:
- ≥18-years of age
- Acute respiratory failure (must meet all of the following)
- Receipt of mechanical ventilation
- Presence of endotracheal tube
- PEEP ≥ 5
- P/F ratio ≤ 300 (adjusted for altitude)
- Presence of a central venous catheter
- 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 (negative pregnancy test required for women of child-bearing
potential)
- Dialysis dependence at 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-Barre
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)
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