Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03194750 |
| Other study ID # |
F160407004 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2016 |
| Est. completion date |
September 7, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
University of Alabama at Birmingham |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Renal failure and resuscitation measures in critically ill patients can result in fluid
overload. Fluid overload in renal failure patients can cause harmful effects like pulmonary
edema, anasarca and congestive cardiac failure exacerbations among other complications. These
have been associated with increased time on the ventilator, increased length of stay in the
ICU, and higher overall mortality for patients requiring dialysis in the ICU.
The current standard of care for adjusting fluid removal rates in patients on continuous
renal replacement therapy relies on clinical judgement. Clinicians take into account factors
like the patient's condition, vasopressor requirements, kidney function, total intake and
outputs, vital signs, and physical examination findings when making daily changes to fluid
removal rates on dialysis machines. Such assessment is highly subjective and can be
imprecise/inaccurate leading to hypotension and hemodynamic instability in a critically ill
patient.
Use of conventional ultrasound by physicians to assess volume status using compressibility of
the inferior vena cava has been shown to be a reliable predictor of volume status and can
help guide therapy. Such use makes bedside volume assessment a non-invasive, rapid,
repeatable point of care tool that can provide objective data to guide fluid removal
determine velocity of fluid removal and help identify patients at risk of hypotension and
hemodynamic instability during the process of fluid removal. Apart from rare possible local
allergic reactions to ultrasound jelly and transient local discomfort, the disadvantages are
minimal. Ultrasonography has been considered a safe imaging modality. This protocol will
measure inferior vena cava compressibility using the General Electric VScan with Dual Probe,
which has FDA approval for abdominal and vascular imaging in humans.
Description:
The study consists of gathering patient data from the chart and performing ultrasound
measurements of inferior vena cava compressibility at the start of continuous renal
replacement therapy (CRRT) in patients on the mechanical ventilator in the ICU. Ultrasound
measurements on the abdomen, as well as recording of clinical data like intake/output,
weight, pulse pressure variability, vasopressor requirement, nutrition requirement,
ventilator settings, CRRT settings, and certain laboratory data will be performed at the
start of the study and then daily for the next 3 days. On the 3rd day, 50 mL of dialysis
waste fluid will be collected and stored for future analysis.
At the start of the study, participants will be randomized to two groups. Study activities
are identical between the two groups and both groups receive ultrasound measurements on the
abdomen. However, in one group the attending nephrologist on the Acute Consult service will
be provided with inferior vena cava compressibility measurement information each day before
the start of rounds. Randomization will follow a predefined schedule, known only to the
research coordinator, Laura Latta. At no time will the attending physicians receive the
ultrasound measurements for the group randomized to not have their data shared.
In addition, the resident, fellow, and attending on the Acute Consult service will be asked
to assess the volume status of each participant at the start of the study and then daily for
next 3 days. The volume assessment will consist of answering the following question, "Would
you recommend fluid removal in this patient today (Yes/No/Unsure)?" The question will be
asked verbally by Dr. Narasimha Krishna. Each individual's level of training (post-graduation
year) and the response will be recorded. Individual names will not be recorded and responses
will not be shared with the attending. Responses to this question are not anticipated to
affect management of the participant.
During the follow up phase, the electronic medical records will be checked at day 7 and day
30 to determine if the participant is still in the intensive care unit, is still on the
ventilator, or is still alive, or still in the hospital. Both groups will have the same
follow up time.
Primary outcome measures include: 1) Time to extubation; 2) Length of ICU stay; 3) Length of
hospital stay; and 4) 30 day mortality.
Secondary outcome measures include: 1) Difference in net fluid removal by CRRT at day 3
between the 2 groups; 2) Agreement between volume assessment and inferior vena cava
compressibility by level of training.
