Volume OverloadNCT03194750
Ultrasound Assessment of Volume in Patients on Continuous Dialysis
A study testing Share ultrasound measurement of IVC collapsibility to Nephrology Attending and Do not share ultrasound measurement of IVC collapsibility to Nephrology Attending in people with Volume Overload and Kidney Failure, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Volume Overload, Kidney Failure, Respiratory Failure
- What is being tested?
- Share ultrasound measurement of IVC collapsibility to Nephrology Attending and Do not share ultrasound measurement of IVC collapsibility to Nephrology Attending
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2016to 7 Sep 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute kidney injury requiring initiation of continuous renal replacement therapy
- Respiratory failure requiring mechanical ventilation
Who cannot join
- cirrhosis of liver
- pregnant woman
- abdominal surgery interfering with placement of ultrasound probe
- end-stage kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Volume Overload, Kidney Failure, Respiratory Failure
- Being tested
- Share ultrasound measurement of IVC collapsibility to Nephrology Attending, Do not share ultrasound measurement of IVC collapsibility to Nephrology Attending
- Medical subject headings
- Edema, Renal Insufficiency, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Share ultrasound measurement of IVC collapsibility to Nephrology AttendingOther
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.
Do not share ultrasound measurement of IVC collapsibility to Nephrology AttendingOther
Respiratory variability of IVC diameter will be measured, but the measurement result will not be shared with the treating team.
| Study group | Role | What they receive |
|---|---|---|
| Share Data | Experimental | Not described Receives: Other: Share ultrasound measurement of IVC collapsibility to Nephrology Attending |
| Do Not Share Data | Active comparator | Not described Receives: Other: Do not share ultrasound measurement of IVC collapsibility to Nephrology Attending |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to extubation
Length of time the participant is intubated from the start of the study up until the 30 day chart follow up.
Measured: Start of study to up to 30 days
Length of ICU stay
Length of time the participant remains in the ICU from the start of the study up until chart follow up at 30 days.
Measured: Start of study to up to 30 days
Length of hospital stay
Length of time the participant remains in the hospital up until the 30 day chart follow up.
Measured: Start of study to up to 30 days
30 day mortality
Measured: Start of study to day 30
Secondary outcomes (2)
Difference in net fluid removal by CRRT at day 3
As measured by documented total intake and output
Measured: Start of study to day 3
Agreement between volume assessment and inferior vena cava collapsibility by level of training.
As measured by a kappa statistic between a yes/no question and a predefined IVC collapsibility threshold for fluid removal.
Measured: Start of study to day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start1 Jun 2016
- Primary completion7 Sep 2023
- Study completion7 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volume OverloadStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Judd, University of Alabama at Birmingham
- Investigators
- Eric Judd, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194750
- Sponsor's protocol ID
- F160407004
- Status last verified
- Sep 2023
- First submitted
- 13 Jun 2017
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Volume in Patients on Continuous Dialysis
- ClinicalTrials.gov ID
- NCT03194750
- Acronym / sponsor ID
- F160407004
- Conditions
- Volume Overload, Kidney Failure, Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 21 Jun 2017 (actual)
- 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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Share Data | Experimental | Other: Share ultrasound measurement of IVC collapsibility to Nephrology Attending |
| Do Not Share Data | Active comparator | Other: Do not share ultrasound measurement of IVC collapsibility to Nephrology Attending |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute kidney injury requiring initiation of continuous renal replacement therapy
- Respiratory failure requiring mechanical ventilation
Key exclusion criteria (4 listed)
- cirrhosis of liver
- pregnant woman
- abdominal surgery interfering with placement of ultrasound probe
- end-stage kidney disease
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 |
|---|---|---|
| Share ultrasound measurement of IVC collapsibility to Nephrology AttendingNephrology 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. | Other | Share Data |
| Do not share ultrasound measurement of IVC collapsibility to Nephrology AttendingRespiratory variability of IVC diameter will be measured, but the measurement result will not be shared with the treating team. | Other | Do Not Share Data |
Primary outcome
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.
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.
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.
30 day mortality
Time frame: Start of study to day 30
2 secondary outcomes
Difference in net fluid removal by CRRT at day 3
Time frame: Start of study to day 3
Agreement between volume assessment and inferior vena cava collapsibility by level of training.
Time frame: Start of study to day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Volume Overload
Recruiting
Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure
Acute Kidney Injury, Fluid Overload
Recruiting
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Chronic Heart Failure, CKD Stage 3
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
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.
Eric Judd, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Share ultrasound measurement of IVC collapsibility to Nephrology Attending and Do not share ultrasound measurement of IVC collapsibility to Nephrology Attending in people with Volume Overload and Kidney Failure, run by University of Alabama at Birmingham 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 8 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to extubation (time frame: Start of study to up to 30 days). The study lists 4 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 Sep 2023.