Non-invasive Assessment to Predict Tolerance to Fluid Removal on Intermittent Kidney Replacement Therapy (TECHNO-HDF)

  • STATUS
    Recruiting
  • End date
    Apr 1, 2024
  • participants needed
    75
  • sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)
Updated on 27 April 2022
hemodiafiltration

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.

Description

Background

Fluid accumulation and intra-dialytic hypotensive events (IDHE) are independently associated with worse prognosis in patients undergoing intermittent kidney replacement therapy (IKRT), both in the setting of acute kidney injury (AKI) and in patients with end-stage kidney disease (ESKD). An optimal IKRT prescription needs to achieve adequate fluid homeostasis while mitigating the risk of IDHE. However, predicting tolerance to fluid removal is challenging, particularly in acutely ill hospitalized patients in whom intravascular volume and compensatory mechanisms are affected by the presence of acute illness.

The following modalities will be investigated in this study to determine if they predict IDHE during hemodialysis in hospitalized patients:

  • The modified VExUS assessment before the hemodialysis session
  • Estimation of absolute blood volume during the hemodialysis session
  • Change in carotid Doppler parameters in response to fluid administration at the start of hemodialysis
    Objectives

Primary objective:

To determine whether the studied modalities accurately predicts intradialytic hypotension events (IDHE) in hospitalized patients, including critically ill and non-critically ill patients

Secondary objectives:

To determine whether the studied modalities predict cerebral desaturations events measured by near infra-red tissue oximetry (NIRS) during IKRT To determine if adding information from the studied modalities result in significant improvement in the risk prediction of IDHE when added to the subjective assessment of the attending clinician

Study design:

A cohort of hospitalized patients undergoing hemodiafiltration with ultrafiltration will be monitored during two separate dialysis sessions. The following markers will assessed:

  1. Absolute blood volume, estimated based on the change in relative blood volume measured by the Fresenius BVM after infusion of a replacement fluid bolus of 240 mL given 15 minutes after dialysis initiation using the Kron et al method.
  2. The modified VExUS from the Doppler assessment of the portal, hepatic, femoral, and splenic vein before the hemodialysis treatment.
  3. Change in the carotid Doppler waveform following the replacement fluid bolus of 240 mL given 15 minutes after dialysis initiation.
    Outcomes

Primary endpoint

  1. Intradialytic hypotensive events (IDHE), as defined by a systolic arterial blood pressure (sBP) nadir of <90 mmHg or, in patients with a starting sBP of less than 90 mmHg, a decrease of ≥10 mmHg from baseline), during either the peri-dialytic or the post-dialytic period (within 15 minutes of dialysis discontinuation) with an intervention (dialysis interruption, vasopressor initiation or increase, fluid bolus, interruption of net ultrafiltration, change in body position with therapeutic intent).

Secondary endpoints

  1. Intradialytic cerebral desaturation events
  2. The proportion of sessions with at least one episode of IDHE within 14 days after enrolment
  3. Mortality at 90 days
    Reporting

The results will be reported according to the STROBE guidelines. Reporting will be done separately for the 3 assessment modalities and may be published independently from each other.

Details
Condition Acute Kidney Injury, Chronic Kidney Disease Stage 5 on Dialysis, Chronic Kidney Failure, Intradialytic Hypotension, Fluid Overload
Treatment Estimated absolute blood volume, Modified VExUS evaluation, Change in carotid Doppler waveform in response to fluid bolus
Clinical Study IdentifierNCT05270759
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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) sessions 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)
Planned blood product transfusions during the session
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