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NCT07033273: IVC-HD
Inferior Vena Cava Collapsibility Index and Intradialytic Hypotension
trial testing Non-invasive Monitoring in End-Stage Renal Disease Requiring Haemodialysis in 188 participants. Currently enrolling.
31 July 2025
Quick facts
| Lead sponsor | First Affiliated Hospital of Wannan Medical College |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 188 |
| Start date | 27 January 2025 |
| Primary completion | 31 July 2025 |
| Estimated completion | 31 July 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Non-invasive Monitoring
Conditions studied
- End-Stage Renal Disease Requiring Haemodialysis — all drugs for End-Stage Renal Disease Requiring Haemodialysis →
- Intradialytic Hypotension — all drugs for Intradialytic Hypotension →
Sponsor
First Affiliated Hospital of Wannan Medical College
Who can join
Adults 18 to 80, any sex, with End-Stage Renal Disease Requiring Haemodialysis or Intradialytic Hypotension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07033273
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Related trials
Other trials of Non-invasive Monitoring
Trials testing the same drug.
- NCT07033260 — Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension · recruiting
- NCT07022847 — Pleth Variability Index for Predicting Low Blood Pressure During Maintenance Hemodialysis · recruiting
- NCT04635371 — Monitoring Patients With Acute Cardiac Disease Using a Wireless, Wearable, Non-invasive Monitor · completed
Other recruiting trials for End-Stage Renal Disease Requiring Haemodialysis
Currently open trials in the same condition.
- NCT07201467 — To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN060 in ESRD Dialysis Patients · Phase 1, PHASE2 · recruiting
- NCT07033260 — Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension · recruiting
- NCT07022847 — Pleth Variability Index for Predicting Low Blood Pressure During Maintenance Hemodialysis · recruiting
- NCT07003828 — Hemodialysis-Induced Renal Perfusion Decline: Unraveling the Pathophysiological Mechanisms Linking Intradialytic Circula · active not recruiting
Other First Affiliated Hospital of Wannan Medical College trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07033273 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by First Affiliated Hospital of Wannan Medical College
- Last refreshed: 24 June 2025
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