At a glance

ClinicalIndex Comparison Record

N/ACompleted· 20 target

Drug / intervention

NICaSdevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02719223

NCT02719223N/ACompleted

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The Effect of On-Line Hemodiafiltration Versus High Flux Hemodialysis on Hemodynamic Parameters in Patients With Intra-Dialytic Hypotension

Western Galilee Hospital-Nahariya·interventional·Posted Mar 25, 2016·Updated Jun 11, 2019

In Brief

A clinical study evaluating NICaS for Intradialytic Hypotension. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Rationale and objectives 1. Patients on On Line Hemodiafiltration (OL- HDF) are more stable hemodynamically with less Intra Dialytic Hypotension (IDH) episodes compared to conventional hemodialysis (HD). The investigator will follow the hemodynamic parameters during the dialysis sessions (HD and OL-HDF) by using the new non invasive technology, the NICAS device. 2. By switching each patient with IDH from HD to OL- HDF, the investigators will evaluate the hemodynamic parameters and compare the two renal replacement treatment modalities, and prove the superiority of OL-HDF over HD regarding the hemodynamic measures.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsIntradialytic Hypotension

CountriesIsrael

Collaborators--

Timeline

N/ACompletedFinished

20162017201820192020202120222023202420252026

First PostedMar 2016

Enrollment StartJan 2017

Primary CompletionDec 2018

Study CompletionDec 2018

TodayJul 2026

First PostedMar 25, 2016

Enrollment StartJan 1, 2017

Primary CompletionDec 30, 2018

Study CompletionDec 31, 2018

TodayJul 2, 2026

Enrollment to primary: 2.0 yearsPosted 10.3 years ago

Interventions

NICaSdevice

The NICaS is a non invasive device for measuring and calculating of hemodynamic parameters including mean arterial pressure (mm/Hg), cardiac index (l/min/m2) and total peripheral resistance (dynes/sec/cm5).