Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Wannan Medical College

About this trial

This multicenter, prospective observational study aims to evaluate the predictive value of carotid corrected flow time (FTc) and peak flow velocity variability (PFVV) for hypotension during maintenance hemodialysis. Conducted at The First Affiliated Hospital of Wannan Medical College, Wuhu City Second People's Hospital, Wuhu Hospital of Chinese Traditional Medicine, Wuhu Jinghu District Hospital, and Wuhu Guangji Hospital, the study will include adult patients (≥18 years) with end-stage renal disease (ESRD) on long-term hemodialysis for at least three months. Patients with acute kidney injury, severe cardiac conditions, or other factors affecting results will be excluded. Ultrasound assessments of FTc and PFVV will be performed once, at 1 hour after dialysis initiation. Blood pressure will be monitored during the procedure. The primary outcome is to determine the sensitivity, specificity, and optimal cutoff points of FTc and PFVV in predicting intradialytic hypotension. The estimated sample size is 183 participants, with analysis performed using ROC curves and multivariate regression. The protocol complies with ethical standards and aims to develop a simple, non-invasive, real-time tool to improve patient safety and individualized management during hemodialysis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Adult patients aged 18 to 80 years with end-stage renal disease who have been receiving maintenance hemodialysis for more than three months at participating dialysis centers. Participants are required to be able to provide informed consent and cooperate with study procedures.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Non-invasive Monitoring

    Other intervention

    All participants will undergo non-invasive ultrasonographic measurement of carotid corrected flow time (FTc) and peak flow velocity variability (PFVV) before and during hemodialysis sessions. No treatment or experimental intervention will be applied.

Treatment groups

183 Participants
are divided into 1 treatment group
Group A: Maintenance Hemodialysis Patients1 intervention

Trial outcomes

Primary outcomes

1

Predictive Value of Carotid Corrected Flow Time (FTc) for Intradialytic Hypotension

The carotid corrected flow time (FTc) is the duration of blood flow in the carotid artery, corrected for heart rate, measured using ultrasonography at 1 hour after hemodialysis initiation. This parameter will be evaluated for its ability to predict hypotension episodes during dialysis, with analysis focusing on sensitivity, specificity, and ROC curve to determine diagnostic accuracy.

Time frame
1 hour after dialysis start during a single session.
2

Predictive Value of Peak Flow Velocity Variability (PFVV) for Intradialytic Hypotension

PFVV represents the variation in peak flow velocity in the carotid artery measured by ultrasonography at 1 hour after hemodialysis start. It reflects vascular volume status and elastic properties. Its capacity to predict intradialytic hypotension will be assessed through sensitivity, specificity, and ROC analysis.

Time frame
1 hour after dialysis start during a single session.

Secondary outcomes

1

Incidence of Intradialytic Hypotension

The proportion of dialysis sessions in which patients experience hypotension, defined as a decrease in systolic blood pressure (SBP) of 20 mmHg or more during the session, will be recorded to estimate clinical event frequency.

Time frame
Up to 1 dialysis session (4 hours)
2

Correlation Between FTc and PFVV and Changes in Blood Pressure

Assessment of the statistical correlation between PVI parameters ( FTc and PFVV) and changes in blood pressure, including systolic blood pressure, diastolic blood pressure, and mean arterial pressure, during the dialysis session.

Time frame
1 hour after dialysis start during a single hemodialysis session (total duration up to 4 hours)

Other outcomes

Sponsors and contacts

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First Affiliated Hospital of Wannan Medical College

Lead sponsor

Wuhu City Second People's Hospital

Collaborator

Wuhu County Traditional Chinese Medicine Hospital

Collaborator