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

NCT ID: NCT05270759

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 93 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-09-17

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.

Detailed 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
• Removed in protocol version 2.0: 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

Estimated absolute blood volume

Intervention Type: 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.

Modified VExUS evaluation

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Estimated absolute blood volume

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.

Intervention Type: DIAGNOSTIC_TEST

Modified VExUS evaluation

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Adult patient ≥18 year-old

2. Hospitalized at the CHUM in the intensive care unit (ICU) or general ward

3. Receiving or planned ≥3x/week IKRT treatments

4. Planned on-line hemodiafiltration (HDF) or hemodialysis (HD) sessions with ≥1L of fluid removal per session

Exclusion Criteria

1. Planned hospital discharge, death, or transition to comfort care within 48 hours according to the attending physician

2. End of active care (awaiting hospital discharge)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Kidney Foundation of Canada

OTHER

Sponsor Role: collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Beaubien-Souligny, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CR CHUM

Locations

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2022-10134, 21.233

Identifier Type: -

Identifier Source: org_study_id