Comparison of Body Hydration State in Hemodialysis Patients

NCT01814254 | Terminated

• 1 other identifier: 063-11
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemodialysis; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Calf bioimpedance measurement

  2 dialysis treatments within 1 week

Study Arms (1)

Receiving hemodialysis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hemodialysis clinics

You may qualify if:

• Clinically stable

You may not qualify if:

• Implants including pacemakers, implantable pumps, artificial joints
• Limb amputations
• Pregnancy
• Simultaneous participation in another clinical study except observational trials.

Sponsors & Collaborators

• Renal Research Institute: lead

Study Sites (1)

Yorkville Dialysis

New York, New York, 10128, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Kotanko, MD

  Renal Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: March 19, 2013
• Study Start: July 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 24, 2016

Record last verified: 2016-02

Locations

US (1)