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

NCT00576524 | Terminated Phase 2 Results

• 1 other identifier: 2007-12-5712
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intradialytic Hypotension; End Stage Renal Disease; Low Blood Pressure

Keywords

Hypotension during dialysis; End Stage Renal Disease; Decrease complications during dialysis; Low Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Fluid Removal

  Fluid removed as percentage of dry body weight.

  6 weeks

Secondary Outcomes (2)

• Extra Days to Achieve Target Dry Weight

  6 weeks

• Changes in Heart Rate and Blood Pressure Measured by a Non-invasive Cuff.

  6 weeks

Study Arms (2)

Sham Device first, ITD next

EXPERIMENTAL

Subjects will be randomized to recieve sham device first, ITD next after washout of 7 days.

Device: ITD; Device: Sham

ITD first, sham device next

EXPERIMENTAL

Subjects will be randomized to receive ITD first, sham device next, after washout of 7 days.

Device: ITD; Device: Sham

Interventions

ITD DEVICE

ITD will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions

Also known as: ResQpod

ITD first, sham device next; Sham Device first, ITD next

Sham DEVICE

Sham will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions

ITD first, sham device next; Sham Device first, ITD next

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Advanced Circulatory Systems: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Hypotension

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Marsha Wallace
• Organization: Children's Hospital of Philadelphia

wallacem@email.chop.edu

(215) 590-0119

Study Officials

• Vijay Srinivasan, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 19, 2007
• Study Start: September 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: February 26, 2013
• Results First Posted: February 26, 2013

Record last verified: 2013-01

Locations

US (1)