Acute Kidney InjuryTECHNO-HDFNCT05270759
Non-invasive Assessment to Predict Tolerance to Fluid Removal on Intermittent Kidney Replacement Therapy
An observational study of Acute Kidney Injury and Chronic Kidney Disease Stage 5 on Dialysis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Chronic Kidney Disease Stage 5 on Dialysis, Chronic Kidney Failure
- What is being tested?
- Estimated absolute blood volume and Modified VExUS evaluation
- Type of treatment
- Injection or infusion
- How many people
- 93 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2022to 17 Sep 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized adults with acute kidney injury or chronic kidney disease requiring hemodialysis with on-line hemodiafiltration.
Who may be able to join
- 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
Who cannot join
- Planned hospital discharge, death, or transition to comfort care within 48 hours according to the attending physician
- End of active care (awaiting hospital discharge)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
About this study
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.
Read the 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:
- 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.
- 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
- Being tested
- Estimated absolute blood volume, Modified VExUS evaluation
- Keywords
- Relative blood volume monitoring, Hemodialysis, Hemodiafiltration, Venous Doppler
- Medical subject headings
- Acute Kidney Injury, Kidney Failure, Chronic, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estimated absolute blood volumeDiagnostic 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 evaluationDiagnostic test
The presence of at least 2/3 abnormal venous Doppler waveforms at the following sites: Portal vein, hepatic vein, and femoral vein.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Estimated absolute blood volume; Diagnostic Test: Modified VExUS evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the initiation of dialysis to 15 minutes after dialysis
Secondary outcomes (3)
Intradialytic cerebral desaturation events
>15% decrease in cerebral oximetry (NIRS) measurements relative to baseline value.
Measured: From the initiation of dialysis to 15 minutes after dialysis
Rate of intradialytic hypotension
The proportion of sessions with at least one episode of intradialytic hypotension (as previously defined) within 14 days from enrollment
Measured: From enrolment to 14 days
Mortality rate
All cause mortality
Measured: From enrolment to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Mar 2022
- Primary completion20 Aug 2024
- Study completion17 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Kidney Foundation of Canada
- Responsible party
- Sponsor
- Investigators
- William Beaubien-Souligny, MD PhD, Principal investigator, CR CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270759
- Sponsor's protocol ID
- 2022-10134, 21.233
- Acronym
- TECHNO-HDF
- Status last verified
- Sep 2024
- First submitted
- 26 Feb 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Will require data sharing agreement
Publications
Joyal R, Proulx J, Gouin M, Huard K, Ledoux-Hutchinson L, Gilbert S, Charbonney E, Denault A, Beaubien-Souligny W. Intra-Dialytic Hypotension and the VExUS Assessment in Hospitalized Patients: A Prospective Cohort Study. Cardiorenal Med. 2026;16(1):248-257. doi: 10.1159/000551739. Epub 2026 Apr 3.
PubMed 41931445
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Assessment to Predict Tolerance to Fluid Removal on Intermittent Kidney Replacement Therapy
- ClinicalTrials.gov ID
- NCT05270759
- Acronym / sponsor ID
- TECHNO-HDF / 2022-10134, 21.233
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- The Kidney Foundation of Canada
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 17 Sep 2024 (actual)
- First posted
- 8 Mar 2022 (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.
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:
- 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.
- The modified VExUS from the Doppler assessment of the portal, hepatic, femoral, and splenic vein before the hemodialysis treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized patients receiving hemodialysis/hemodialfiltration | – | Diagnostic Test: Estimated absolute blood volume, Diagnostic Test: Modified VExUS evaluationAdult 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized adults with acute kidney injury or chronic kidney disease requiring hemodialysis with on-line hemodiafiltration.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Planned hospital discharge, death, or transition to comfort care within 48 hours according to the attending physician
- End of active care (awaiting hospital discharge)
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 |
|---|---|---|
| Estimated absolute blood volumeBaseline 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. | Diagnostic test | Hospitalized patients receiving hemodialysis/hemodialfiltration |
| Modified VExUS evaluationThe presence of at least 2/3 abnormal venous Doppler waveforms at the following sites: Portal vein, hepatic vein, and femoral vein. | Diagnostic test | Hospitalized patients receiving hemodialysis/hemodialfiltration |
Primary outcome
Intradialytic hypotensive event in the peri-dialytic or post-dialytic period
Time frame: From the initiation of dialysis to 15 minutes after dialysis
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.
3 secondary outcomes
Intradialytic cerebral desaturation events
Time frame: From the initiation of dialysis to 15 minutes after dialysis
Rate of intradialytic hypotension
Time frame: From enrolment to 14 days
Mortality rate
Time frame: From enrolment to 90 days
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 19 Sep 2024.
- Derived from this study: PubMed 41931445Joyal R, Proulx J, Gouin M, Huard K, Ledoux-Hutchinson L, Gilbert S, Charbonney E, Denault A, Beaubien-Souligny W. Intra-Dialytic Hypotension and the VExUS Assessment in Hospitalized Patients: A Prospective Cohort Study. Cardiorenal Med. 2026;16(1):248-257. doi: 10.1159/000551739. Epub 2026 Apr 3.
- Individual participant dataSharing planned: Undecided. Will require data sharing agreement
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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.
William Beaubien-Souligny, MD PhD principal investigator
CR CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Chronic Kidney Disease Stage 5 on Dialysis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 4 inclusion and 2 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 19 Sep 2024. 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 Canada. 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?
Intradialytic hypotensive event in the peri-dialytic or post-dialytic period (time frame: From the initiation of dialysis to 15 minutes after dialysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05270759, which also lists 1 linked publication.
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 19 Sep 2024.