Inferior Vena Cava Collapsibility Index and 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 the Inferior Vena Cava Collapsibility Index (IVCCI), along with IVC maximum diameter (IVCmax) and IVC minimum diameter (IVCmin), for intradialytic hypotension in patients undergoing maintenance hemodialysis. The study will be 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. Eligible participants are adults aged 18 years or older with diagnosed end-stage renal disease (ESRD), receiving regular hemodialysis for at least three months. Patients with acute kidney injury, severe cardiac conditions, or other factors likely to influence results will be excluded.
Ultrasound measurements of IVCCI, IVCmax, and IVCmin will be performed once, precisely at 1 hour after dialysis initiation. IVCmax will be measured during inspiration when the IVC is at its largest, and IVCmin during expiration when it is at its smallest. Blood pressure will be monitored continuously during the procedure. The primary objective is to assess the sensitivity, specificity, and optimal cutoff values of IVCCI, IVCmax, and IVCmin for predicting hypotension, aiming to provide a simple and non-invasive tool to facilitate personalized dialysis management and reduce intradialytic hypotension. A sample size of 188 participants is estimated, with data analyzed using ROC curves and multivariate regression methods. The study protocol adheres to ethical standards and regulatory requirements, demonstrating potential to improve patient safety and treatment outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older.
Diagnosed with end-stage renal disease (ESRD).
Undergoing regular hemodialysis for at least three months.
Disqualifiers
Pregnant or breastfeeding women.
Hemodynamically unstable patients or those requiring vasopressor support.
Patients with severe cardiac conditions, including congestive heart failure -classified as NYHA Class III-IV or severe valvular disease.
Patients with known allergies to dialysis filters.
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 interventionAll participants will undergo non-invasive measurement of Inferior Vena Cava Collapsibility Index (IVCCI) using ultrasound and routine blood pressure monitoring before and during hemodialysis sessions. No treatment or experimental intervention will be applied.
Treatment groups
188 Participants
are divided into 1 treatment groupGroup A: Maintenance Hemodialysis Patients1 intervention
Trial outcomes
Primary outcomes
1
Predictive Value of IVCCI at 1 Hour for Intradialytic Hypotension
The IVC diameters willbe measured using bedside ultrasonography with a portable ultrasound device. The probe will be placed subcutaneously on the right side of the abdomen, along the mid-axillary line, approximately 2-3 cm below the hepatic vein confluence.End-expiratory diameter (IVCmin): measured during expiration when the IVC is at its smallest. End-inspiratory diameter (IVCmax): measured during inspiration when the IVC is at its largest. IVCCI calculated as (IVCmin-IVCmax)/IVCmax × 100% measured 1 hour after dialysis initiation.The sensitivity, specificity, and area under the ROC curve of dIVC in predicting hypotension events during dialysis.
Time frame
1 hour after dialysis initiation2
Predictive Value of IVCmax at 1 Hour for Intradialytic Hypotension
The sensitivity, specificity, and ROC of IVCmax measured 1 hour after dialysis initiation in predicting hypotension.
Time frame
1 hour after dialysis initiation3
Predictive Value of IVCmin at 1 Hour for Intradialytic Hypotension
The sensitivity, specificity, and ROC of IVCmin measured 1 hour after dialysis initiation in predicting hypotension.
Time frame
1 hour after dialysis initiation.Secondary outcomes
1
Incidence of Intradialytic Hypotension
The proportion of dialysis sessions experiencing hypotension, defined as a systolic blood pressure decrease ≥20 mmHg or associated symptoms.
Time frame
Up to one dialysis session (4 hours)2
Correlation Between IVC Parameters and Blood Pressure Changes
Analysis of the correlation between IVCmax, IVCmin, and IVCCI measured at 1 hour and changes in systolic, diastolic, and mean arterial pressure from start to 1 hour.
Time frame
Up to one dialysis session (4 hours)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
First Affiliated Hospital of Wannan Medical College
Lead sponsor
Wuhu County Traditional Chinese Medicine Hospital
Collaborator
Wuhu City Second People's Hospital
Collaborator
Source ClinicalTrials.gov