Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention
Primary Purpose
Intradialytic Hypotension
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
pressure stockings
Midodrine
pressure stockings and midodrine
Sponsored by
About this trial
This is an interventional treatment trial for Intradialytic Hypotension
Eligibility Criteria
Inclusion Criteria:
- 18 years old or older
- Have been on maintenance hemodialysis at the facility for at least six months
- Have not had un-excused missed treatments for six months
- Is symptomatic to HD treatments
- Males and non-pregnant/non-nursing females, as confirmed via urine pregnancy testing of women of child bearing potential
Exclusion Criteria:
- Patient refusal
- Currently on Midodrine at the start of the Phase 1, Observation period
- Any known contraindications to Midodrine
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Phase 1 Group 1
Phase 1 Group 2
Phase 1 Group 3
Arm Description
pressure stockings worn during dialysis treatment
Midodrine before dialysis treatment
pressure stocking and Midodrine
Outcomes
Primary Outcome Measures
Hypotension
Post dialysis BP measured in mm/Hg
Weight
Post dialysis weight measure in kg
Cardiac Index
Cardiac Index results from NICaS results vs Echocardiogram results measured in L/min/m2
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03080441
Brief Title
Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention
Official Title
Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 11, 2016 (Actual)
Primary Completion Date
April 1, 2017 (Anticipated)
Study Completion Date
May 1, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nimedical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
This is a research study to test the application of FDA-approved, non-invasive device (NICaS) that measure the performance of your heart during HD treatment.
Detailed Description
The incidence of intradialytic hypotension (IDH) events, reported to occur in 15% to 50% of hemodialysis (HD) treatments, is still high despite major technical advances in HD technology. By definition, excessive reduction in intravascular volume by ultrafiltration and limited vascular refilling from tissues into the vascular space is the cause of IDH. Chronic HD patients exhibit a high prevalence of peripheral vascular and cardiac abnormalities. Specifically, hemodynamic instability during HD can occur due to insufficient reduction in venous unstressed volume, poor diastolic filling under reduced atrial pressures associated with diastolic dysfunction, altered cardiac contractility, and impaired vascular reactivity. An IDH event can lead to myocardial cerebral and other organ ischemia. Long- and short-term adverse outcomes have been associated with IDH, a common HD complication and significant cause of morbidity.
Recent pilot studies suggest that in IDH-prone subjects, measurements of hemodynamic variables during HD can be used to categorize the hemodynamic response into three subgroups: cardiac power index (CPI) reduction with stable total peripheral resistance (TPR), TPR reduction with stable CPI, and reduction in TPR and CPI groups. It is hypothesized that targeted intervention for each subgroup can reduce IDH.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intradialytic Hypotension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phase 1 Group 1
Arm Type
Experimental
Arm Description
pressure stockings worn during dialysis treatment
Arm Title
Phase 1 Group 2
Arm Type
Experimental
Arm Description
Midodrine before dialysis treatment
Arm Title
Phase 1 Group 3
Arm Type
Experimental
Arm Description
pressure stocking and Midodrine
Intervention Type
Device
Intervention Name(s)
pressure stockings
Intervention Description
pressure stockings worn during dialysis throughout treatment period
Intervention Type
Drug
Intervention Name(s)
Midodrine
Intervention Description
administered Midodrine before each dialysis treatment during treatment period based on PI's judgement. Including consideration of blood pressure.
Intervention Type
Other
Intervention Name(s)
pressure stockings and midodrine
Intervention Description
combination of Midodrine and pressure stocking before each dialysis treatment throughout treatment period
Primary Outcome Measure Information:
Title
Hypotension
Description
Post dialysis BP measured in mm/Hg
Time Frame
6 weeks
Title
Weight
Description
Post dialysis weight measure in kg
Time Frame
6 weeks
Title
Cardiac Index
Description
Cardiac Index results from NICaS results vs Echocardiogram results measured in L/min/m2
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years old or older
Have been on maintenance hemodialysis at the facility for at least six months
Have not had un-excused missed treatments for six months
Is symptomatic to HD treatments
Males and non-pregnant/non-nursing females, as confirmed via urine pregnancy testing of women of child bearing potential
Exclusion Criteria:
Patient refusal
Currently on Midodrine at the start of the Phase 1, Observation period
Any known contraindications to Midodrine
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no current plan to share IPD with other researchers
Learn more about this trial
Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention
We'll reach out to this number within 24 hrs