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Ultrasound Assessment of Volume in Patients on Continuous Dialysis

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ClinicalTrials.gov Identifier: NCT03194750
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Eric Judd, University of Alabama at Birmingham

Brief 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.


Condition or disease Intervention/treatment Phase
Volume Overload Kidney Failure Respiratory Failure Other: Share ultrasound measurement of IVC collapsibility to Nephrology Attending Other: Do not share ultrasound measurement of IVC collapsibility to Nephrology Attending Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Ultrasound Assessment of Volume in Patients on Continuous Dialysis
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Ultrasound

Arm Intervention/treatment
Experimental: Share Data Other: Share ultrasound measurement of IVC collapsibility to Nephrology Attending
Nephrology attending will be provided with the respiratory variability of IVC diameter as a percent, in addition to a predefined cutoff for responsiveness to volume resuscitation of < 12%. The information will be provided before rounds and before the attending sets the fluid removal goals on dialysis for that day.

Active Comparator: Do Not Share Data Other: Do not share ultrasound measurement of IVC collapsibility to Nephrology Attending
Respiratory variability of IVC diameter will be measured, but the measurement result will not be shared with the treating team.




Primary Outcome Measures :
  1. Time to extubation [ Time Frame: Start of study to up to 30 days ]
    Length of time the participant is intubated from the start of the study up until the 30 day chart follow up.

  2. Length of ICU stay [ Time Frame: Start of study to up to 30 days ]
    Length of time the participant remains in the ICU from the start of the study up until chart follow up at 30 days.

  3. Length of hospital stay [ Time Frame: Start of study to up to 30 days ]
    Length of time the participant remains in the hospital up until the 30 day chart follow up.

  4. 30 day mortality [ Time Frame: Start of study to day 30 ]

Secondary Outcome Measures :
  1. Difference in net fluid removal by CRRT at day 3 [ Time Frame: Start of study to day 3 ]
    As measured by documented total intake and output

  2. Agreement between volume assessment and inferior vena cava collapsibility by level of training. [ Time Frame: Start of study to day 3 ]
    As measured by a kappa statistic between a yes/no question and a predefined IVC collapsibility threshold for fluid removal.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute kidney injury requiring initiation of continuous renal replacement therapy
  • Respiratory failure requiring mechanical ventilation

Exclusion Criteria:

  • cirrhosis of liver
  • pregnant woman
  • abdominal surgery interfering with placement of ultrasound probe
  • end-stage kidney disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194750


Contacts
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Contact: Laura Latta 205-975-8638 alatta@uabmc.edu

Locations
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United States, Alabama
UAB University Hospital Recruiting
Birmingham, Alabama, United States, 35294
Contact: Laura Latta    205-975-8638    alatta@uabmc.edu   
Principal Investigator: Eric Judd, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Eric Judd, MD University of Alabama at Birmingham

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Responsible Party: Eric Judd, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03194750     History of Changes
Other Study ID Numbers: F160407004
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Renal Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Kidney Diseases
Urologic Diseases