Trial Outcomes & Findings for Application of Impedance Threshold Device Technologies to Treat and Prevent Hypotension During Dialysis (NCT NCT00576524)

Results Overview

Fluid removed as percentage of dry body weight.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

6 weeks

Results posted on

2013-02-26

Participant Flow

The study recruited subjects from September 2007 to February 2011. The study will be performed in the Dialysis Unit of the Division of Nephrology, Department of Pediatrics at the Children's Hospital of Philadelphia (CHOP) with informed consent.

The study design will consist of a "run-in phase", followed by a randomized, cross-over, clinical "intervention phase" with application of the ITD (sham or -7 cm H2O) in 20 pediatric subjects undergoing regular hemodialysis.

Participant milestones

Participant milestones
Measure	ITD First, Sham Device Next A group of subjects will be randomized to receive the ITD first, followed by sham 7 days later.	Sham Device First, ITD Next A group of subjects will be randomized to receive sham first, followed by ITD 7 days later.
Overall Study STARTED	2	0
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham Device n=2 Participants A group of subjects will be randomized to receive the placebo sham device.	ITD Device A group of subjects will be randomized to receive Impedance Threshold Device.	Total n=2 Participants Total of all reporting groups
Age Categorical <=18 years	2 participants n=5 Participants	—	2 participants n=5 Participants
Age Categorical Between 18 and 65 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age Categorical >=65 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants	—	0 Participants n=5 Participants
Sex: Female, Male Male	NA Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	—	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Data not analyzed - study closed due to lack of recruitment

Fluid removed as percentage of dry body weight.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: Data not analyzed - study closed due to lack of recruitment

Extra number of days required for hemodialysis/ultrafiltration to achieve dry body weight

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: Data not analyzed - study closed due to lack of recruitment

Outcome measures

Outcome data not reported

Adverse Events

Sham Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ITD Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marsha Wallace

Children's Hospital of Philadelphia

Phone: (215) 590-0119

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place