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NCT03929471
Target Weight Correction and Vascular Stiffness in Hemodialysis Patients
NA trial testing Target weight correction protocol in Fluid Overload in 22 participants. Completed in 1 July 2020.
1 June 2020
Quick facts
| Lead sponsor | University of Alberta |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 22 |
| Start date | 1 September 2019 |
| Primary completion | 1 June 2020 |
| Estimated completion | 1 July 2020 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Target weight correction protocol
Conditions studied
- Fluid Overload — all drugs for Fluid Overload →
- Vascular Stiffness — all drugs for Vascular Stiffness →
Sponsor
University of Alberta
Who can join
18 and older, any sex, with Fluid Overload or Vascular Stiffness. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Title of the study: Target weight correction and vascular stiffness in hemodialysis patients Study design: Randomized clinical trial in the study centre at two locations Applied medical device: 1. Body Composition Monitor' (BCM, Fresenius) to measure fluid volume overload. 2. Arteriograph 24 (Tensiomed, Budapest, Hungry) to assess vascular stiffness before, during and after the intervention. Study hypothesis: A protocolized adjustment of target weight guided by bio-impedance spectroscopy will improve fluid status, systolic and diastolic blood pressure, and reduce the arterial wall stiffness without increasing the prevalence of intradialytic hypotension. Aim of the study: 1. To demonstrate improvement in fluid status by a target weight correction protocol which applies BCM measurements. 2. To demonstrate that better fluid volume control is associated with a) improvement in vascular health as assessed by pulse wave velocity and augmentation index and b) reduction in antihypertensive medications use. 3. To show that this approach does not lead to more episodes with intradialytic hypotension. The number of patients: 70 patients
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03929471
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03929471 (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 University of Alberta
- Last refreshed: 28 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03929471.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing