Ultrasound Assessment of Volume in Patients on Continuous Dialysis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Kidney Failure
- Respiratory Failure
- Volume Overload
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT03194750
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Eric Judd, MD University of Alabama at Birmingham