Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01814254 · ClinicalTrials.gov registry record
Comparison of Body Hydration State in Hemodialysis Patients
A clinical trial, sponsored by Renal Research Institute.
- Terminated
- Registry status
- 67
- Enrollment target
NCT01814254 is a clinical trial that was terminated before completion, run by Renal Research Institute. The registered enrollment target is 67 participants.
The verdict
NCT01814254 was terminated before completion, sponsored by Renal Research Institute.
- TERMINATED
- Registry status
- 67 participants
- Enrollment target
Study Summary
Estimation of hydration state in dialysis patients is a major challenge in clinical practice. Although many methods have been studied, none have been established yet for clinical routine practice. The investigators have developed a method, using segmental and calf bioimpedance spectroscopy (cBIS) techniques to measure body hydration. The device we used based on the FDA-approved Hydra 4200 (Xitron Technologies, San Diego, CA). The Hydra 4200 was initially developed to measure whole body and segmental body fluid volumes but Hydra is approved only for measuring healthy subjects. The cBIS monitors hydration state by continuously measuring change in resistance and resistivity in the calf during hemodialysis (HD) or it can be used for simple measurement before, during and after dialysis. Preliminary results in clinical studies have shown that optimal hydration state of HD patients may be determined by the calf method. This study aims to compare the Hydra 4200 to two other devices: the FDA approved ZOE (100 kHz) Fluid Status Monitor (Noninvasive Medical Technologies, Inc, Las Vegas) and a modified version ZOE 5 kHz. The modified ZOE monitor (ZOE (5 kHz)) delivers frequency of 5 kHz and 0.8 mA current instead of 100 kHz and 2 mA. The subjects of this study include a group of hemodialysis patients and a group of healthy controls. The healthy controls are used to identify a normal range within the healthy population for each method. Each hemodialysis patient will be studied twice in different hydration state. The study will not change the procedure of the patient's dialysis treatment. Since all devices are based on noninvasive bioimpedance technique, this study has minimal risk.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-02 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01814254
The ClinicalTrials.gov registry entry for NCT01814254 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Renal Research Institute, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01814254 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01814254 about?
NCT01814254 is a clinical study titled "Comparison of Body Hydration State in Hemodialysis Patients". Estimation of hydration state in dialysis patients is a major challenge in clinical practice. Although many methods have been studied, none have been established yet for clinical routine practice. The investigators have developed a method, using segmental and calf bioimpedance spectroscopy (cBIS) t...
What is the current status of trial NCT01814254?
This trial is currently terminated. The enrollment target is 67 participants. The study started on 2011-07. Estimated completion is 2013-02.
Who is sponsoring clinical trial NCT01814254?
This trial is sponsored by Renal Research Institute, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.