Non-invasive Assessment to Predict Tolerance to Fluid Removal on Intermittent Kidney Replacement Therapy

NCT05270759 | Completed FDA Device

• 1 other identifier: 2022-10134, 21.233
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective cohort study aim to investigate the ability of multiple types of assessments including 1) the modified Venous Excess Ultrasound (VExUS) assessment, 2) non-invasive estimation of absolute blood volume (ABV), and 3) change in carotid Doppler at the start of IKRT to predict IDHE in acutely ill hospitalized patients. The secondary aim will be to determine whether each modality improves the prediction of IHDE compared to the evaluation of the attending physician and whether they also predict cerebral hypoxia during IKRT measured by near-infrared spectroscopy (NIRS). Finally, detailed hemodynamic data including relative blood volume monitoring, tissue oximetry, and other parameters will be collected continuously during IKRT sessions enabling exploratory analyses aimed at identifying hemodynamic phenotypes related to IDHE during IKRT.

Conditions

Acute Kidney Injury; Chronic Kidney Disease Stage 5 on Dialysis; Chronic Kidney Failure; Intradialytic Hypotension; Fluid Overload

Keywords

Relative blood volume monitoring; Hemodialysis; Hemodiafiltration; Venous Doppler

Outcome Measures

Primary Outcomes (1)

• Intradialytic hypotensive event in the peri-dialytic or post-dialytic period

  Intradialytic hypotension will be defined as a drop in systolic blood pressure below 90 mmHg which requires an intervention (dialysis interruption, vasopressor initiation or dosage increase, fluid bolus, interruption of net ultrafiltration, change in body position with therapeutic intent) In patients with a baseline below 90 mmHg, it will be defined as a decrease of more than 10 mmHg from baseline systolic blood pressure.

  From the initiation of dialysis to 15 minutes after dialysis

Secondary Outcomes (3)

• Intradialytic cerebral desaturation events

  From the initiation of dialysis to 15 minutes after dialysis

• Rate of intradialytic hypotension

  From enrolment to 14 days

• Mortality rate

  From enrolment to 90 days

Study Arms (1)

Hospitalized patients receiving hemodialysis/hemodialfiltration

Adult patients hospitalized in the intensive care unit (ICU) or general ward receiving hemodiafiltration or hemodiafiltration treatments as least 3 times per week with ≥1L of fluid removal per session Exclusion criteria: * Planned hospital discharge, death, or transition to comfort care within 48 hours according to the attending physician * End of active care (awaiting hospital discharge)

Diagnostic Test: Estimated absolute blood volume; Diagnostic Test: Modified VExUS evaluation

Interventions

Estimated absolute blood volume DIAGNOSTIC_TEST

Baseline absolute blood volume will be inferred based on the change in relative blood volume (RBV) after a single 240mL replacement fluid infusion and then monitored throughout the session via the RBV value.

Hospitalized patients receiving hemodialysis/hemodialfiltration

Modified VExUS evaluation DIAGNOSTIC_TEST

The presence of at least 2/3 abnormal venous Doppler waveforms at the following sites: Portal vein, hepatic vein, and femoral vein.

Hospitalized patients receiving hemodialysis/hemodialfiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized adults with acute kidney injury or chronic kidney disease requiring hemodialysis with on-line hemodiafiltration.

You may qualify if:

• Adult patient ≥18 year-old
• Hospitalized at the CHUM in the intensive care unit (ICU) or general ward
• Receiving or planned ≥3x/week IKRT treatments
• Planned on-line hemodiafiltration (HDF) or hemodialysis (HD) sessions with ≥1L of fluid removal per session

You may not qualify if:

• Planned hospital discharge, death, or transition to comfort care within 48 hours according to the attending physician
• End of active care (awaiting hospital discharge)

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• The Kidney Foundation of Canada: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

Location

MeSH Terms

Conditions

Acute Kidney Injury; Kidney Failure, Chronic; Edema

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• William Beaubien-Souligny, MD PhD

  CR CHUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: March 8, 2022
• Study Start: March 1, 2022
• Primary Completion: August 20, 2024
• Study Completion: September 17, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CA (1)