Ultrasound Assessment of Volume in Patients on Continuous Dialysis

NCT03194750 | Completed

• 1 other identifier: F160407004
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Volume Overload; Kidney Failure; Respiratory Failure

Outcome Measures

Primary Outcomes (4)

• Time to extubation

  Length of time the participant is intubated from the start of the study up until the 30 day chart follow up.

  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.

  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.

  Start of study to up to 30 days

• 30 day mortality

  Start of study to day 30

Secondary Outcomes (2)

• Difference in net fluid removal by CRRT at day 3

  Start of study to day 3

• Agreement between volume assessment and inferior vena cava collapsibility by level of training.

  Start of study to day 3

Study Arms (2)

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

Interventions

Share ultrasound measurement of IVC collapsibility to Nephrology Attending OTHER

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.

Share Data

Do not share ultrasound measurement of IVC collapsibility to Nephrology Attending OTHER

Respiratory variability of IVC diameter will be measured, but the measurement result will not be shared with the treating team.

Do Not Share Data

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB University Hospital

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Edema; Renal Insufficiency; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Eric Judd, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 21, 2017
• Study Start: June 1, 2016
• Primary Completion: September 7, 2023
• Study Completion: September 7, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)