Intradialytic HypotensionPhase 4NCT03080441
Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention
A Phase 4 study testing pressure stockings, Midodrine and pressure stockings and midodrine in people with Intradialytic Hypotension, run by Nimedical.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intradialytic Hypotension
- What is being tested?
- pressure stockings, Midodrine and pressure stockings and midodrine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 11 Nov 2016to 1 May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient refusal
- Currently on Midodrine at the start of the Phase 1, Observation period
- Any known contraindications to Midodrine
About this study
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.
Read the 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.
- Conditions
- Intradialytic Hypotension
- Being tested
- pressure stockings, Midodrine, pressure stockings and midodrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pressure stockingsDevice
pressure stockings worn during dialysis throughout treatment period
MidodrineDrug
administered Midodrine before each dialysis treatment during treatment period based on PI's judgement. Including consideration of blood pressure.
pressure stockings and midodrineOther
combination of Midodrine and pressure stocking before each dialysis treatment throughout treatment period
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Group 1 | Experimental | pressure stockings worn during dialysis treatment Receives: Device: pressure stockings |
| Phase 1 Group 2 | Experimental | Midodrine before dialysis treatment Receives: Drug: Midodrine |
| Phase 1 Group 3 | Experimental | pressure stocking and Midodrine Receives: Other: pressure stockings and midodrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension
Post dialysis BP measured in mm/Hg
Measured: 6 weeks
Weight
Post dialysis weight measure in kg
Measured: 6 weeks
Cardiac Index
Cardiac Index results from NICaS results vs Echocardiogram results measured in L/min/m2
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start11 Nov 2016
- Primary completion1 Apr 2017 (estimated)
- Study completion1 May 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intradialytic HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nimedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080441
- Sponsor's protocol ID
- NIM01
- Status last verified
- Mar 2017
- First submitted
- 8 Feb 2017
- Last updated
- 15 Mar 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no current plan to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention
- ClinicalTrials.gov ID
- NCT03080441
- Acronym / sponsor ID
- NIM01
- Conditions
- Intradialytic Hypotension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- NimedicalIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2016 (actual)
- Primary completion
- 1 Apr 2017 (estimated)
- Study completion
- 1 May 2017 (estimated)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Group 1 | Experimental | Device: pressure stockingspressure stockings worn during dialysis treatment |
| Phase 1 Group 2 | Experimental | Drug: MidodrineMidodrine before dialysis treatment |
| Phase 1 Group 3 | Experimental | Other: pressure stockings and midodrinepressure stocking and Midodrine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Patient refusal
- Currently on Midodrine at the start of the Phase 1, Observation period
- Any known contraindications to Midodrine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pressure stockingspressure stockings worn during dialysis throughout treatment period | Device | Phase 1 Group 1 |
| Midodrineadministered Midodrine before each dialysis treatment during treatment period based on PI's judgement. Including consideration of blood pressure. | Drug | Phase 1 Group 2 |
| pressure stockings and midodrinecombination of Midodrine and pressure stocking before each dialysis treatment throughout treatment period | Other | Phase 1 Group 3 |
Primary outcome
Hypotension
Time frame: 6 weeks
Post dialysis BP measured in mm/Hg
Weight
Time frame: 6 weeks
Post dialysis weight measure in kg
Cardiac Index
Time frame: 1 week
Cardiac Index results from NICaS results vs Echocardiogram results measured in L/min/m2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Individual participant dataSharing planned: No. There is no current plan to share IPD with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pressure stockings, Midodrine and pressure stockings and midodrine in people with Intradialytic Hypotension, run by Nimedical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypotension (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2017.