Application of Impedance Threshold Device Technologies to Treat and Prevent Hypotension During Dialysis (ITD)

Application of Impedance Threshold Device Technologies to Treat and Prevent Intradialytic Hypotension in Children Undergoing Hemodialysis

The purpose of this study is to evaluate the application of the impedance threshold device during hemodialysis in children to optimize fluid removal, reduce the incidence of complications (such as cramps,vomiting and hypotension), and device tolerance.

Study Overview

• Status: Terminated
• Conditions: End Stage Renal Disease; Intradialytic Hypotension; Low Blood Pressure
• Intervention / Treatment: Device: ITD; Device: Sham

Detailed Description

Effective fluid removal during hemodialysis is one of the biggest challenges in children with end-stage renal disease (ESRD). Generally, children do not tolerate having more than 3-4% of their body weight removed during each dialysis session thus necessitating multiple sessions each week to ensure effective renal replacement. Excessive fluid removal is often associated with nausea, vomiting, hypotension and cramps resulting in serious complications in patient care during and immediately after dialysis as well as reduced patient compliance. The development of novel therapies to increase the amount of fluid removed during each session without a corresponding increase in the incidence of complications is therefore very important to improve quality and compliance with hemodialysis; and eventually survival of children with ESRD. The purpose of this study is to evaluate the application of the impedance threshold device during hemodialysis in children to optimize fluid removal, reduce the incidence of complications (such as cramps,vomiting and hypotension), and device tolerance.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects 8-18 years of age
• Subjects undergoing hemodialysis for ESRD

Exclusion Criteria:

• Subjects less than 8 years old or greater than 18 years old.
• Hemodialysis for indications other than ESRD.
• Current symptoms of chest pain, shortness of breath, fever, presence of dilated cardiomyopathy, unstable congestive heart failure, pulmonary hypertension, atrial fibrillation, hyperthyroidism, and aortic stenosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sham Device first, ITD next; Subjects will be randomized to recieve sham device first, ITD next after washout of 7 days.	Device: ITD; ITD will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions; Other Names: ResQpod; Device: Sham; Sham will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions
Experimental: ITD first, sham device next; Subjects will be randomized to receive ITD first, sham device next, after washout of 7 days.	Device: ITD; ITD will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions; Other Names: ResQpod; Device: Sham; Sham will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid Removal	Fluid removed as percentage of dry body weight.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extra Days to Achieve Target Dry Weight	Extra number of days required for hemodialysis/ultrafiltration to achieve dry body weight	6 weeks
Changes in Heart Rate and Blood Pressure Measured by a Non-invasive Cuff.		6 weeks

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Advanced Circulatory Systems
• Investigators: Principal Investigator: Vijay Srinivasan, MD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: December 17, 2007
• First Submitted That Met QC Criteria: December 17, 2007
• First Posted (Estimate): December 19, 2007

Study Record Updates

• Last Update Posted (Estimate): February 26, 2013
• Last Update Submitted That Met QC Criteria: January 22, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: End Stage Renal Disease; Low Blood Pressure; Hypotension during dialysis; Decrease complications during dialysis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic; Hypotension
• Other Study ID Numbers: 2007-12-5712