Idiopathic Intracranial HypertensionNCT03867461

The Effects of MAP and EtCO2 on Venous Sinus Pressures

A study testing Venous Sinus Stenting, Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range) and Adjustment to Mean Arterial Pressure (100-110 mmHg range) in people with Idiopathic Intracranial Hypertension, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to further elaborate the role of both arterial blood pressure and end-tidal carbon dioxide concentration on measured venous pressures. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Idiopathic Intracranial Hypertension
What is being tested?: Venous Sinus Stenting, Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range) and Adjustment to Mean Arterial Pressure (100-110 mmHg range)
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 20 Jun 2019to 25 Sep 2019
Phase: Interventional
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

Adults determined to be candidates for venous sinus stenting

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Prospective Measurement of Blood Pressure and End Tidal Carbon Dioxide Content Effects on Venous Sinus Caliber and Pressures in Patients With Idiopathic Intracranial Hypertension Undergoing Stenting

The purpose of this study is to further elaborate the role of both arterial blood pressure and end-tidal carbon dioxide concentration on measured venous pressures.

Read the detailed description

To prospectively evaluate the effect of changes in end-tidal carbon dioxide and arterial blood pressure on venous sinus pressure measurements in patients undergoing venous sinus stenting under general anesthesia. Venous sinus pressure measurements will increase with increases in both arterial blood pressure and end-tidal carbon dioxide concentrations.

Conditions: Idiopathic Intracranial Hypertension
Being tested: Venous Sinus Stenting, Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range), Adjustment to Mean Arterial Pressure (100-110 mmHg range), Adjustment to Mean Arterial Pressure (60-80 mmHg range), Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range)
Keywords: End-Tidal Carbon Dioxide, Venous Sinus Stenting, Venous Sinus Caliber and Pressures
Medical subject headings: Pseudotumor Cerebri

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Venous Sinus StentingProcedure or surgery
Venous sinus stenting is performed under general anesthesia. Patients are loaded with aspirin and clopidogrel before the procedure. After induction, the right femoral vein is accessed and an 8 F sheath is placed. Intravenous heparin is administered. A 0.070-0.088 guide catheter is navigated into the ipsilateral jugular vein near the jugular bulb. Pre-stenting manometry is performed in every patient. To do so, a Renegade Hi-Flo microcatheter is navigated into the superior sagittal sinus and then used to measure ipsilateral venous pressures across the site of outflow obstruction (this will be the time point where the study intervention will be performed).
Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)Other
End-tidal carbon dioxide concentrations will be adjusted to fall in the End-tidal carbon dioxide concentrations will be adjusted to fall in the 38-40 mmHg range
Adjustment to Mean Arterial Pressure (100-110 mmHg range)Other
Mean arterial pressure will be adjusted to fall in the 100-110 mmHg range
Adjustment to Mean Arterial Pressure (60-80 mmHg range)Other
Mean arterial pressure will be adjusted to fall in the 60-80 mmHg range
Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range)Other
End-tidal carbon dioxide concentrations will be adjusted to fall in the 24-26 mmHg range

Study groups in NCT03867461
Study group	Role	What they receive
Group A	Active comparator	Adult patients determined to be candidates for venous sinus stenting. End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention: For Group A: Initial Recording: Mean Arterial Pressure 60-80 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 100-80 mmHg, End tidal CO2 38-40 mmHg. Receives: Procedure: Venous Sinus Stenting; Other: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range); Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range)
Group B	Active comparator	Adult patients determined to be candidates for venous sinus stenting. End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention: For Group B: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 60-80 mmHg, End tidal CO2 38-40 mmHg, Receives: Procedure: Venous Sinus Stenting; Other: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range); Other: Adjustment to Mean Arterial Pressure (60-80 mmHg range)
Group C	Active comparator	Adult patients determined to be candidates for venous sinus stenting. End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention: For Group C: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 24-26 mmHg, Subsequent Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg, Receives: Procedure: Venous Sinus Stenting; Other: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range); Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range)
Group D	Active comparator	Adult patients determined to be candidates for venous sinus stenting. End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention: For Group D: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 100-100 mmHg, End tidal CO2 24-24 mmHg, Receives: Procedure: Venous Sinus Stenting; Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range); Other: Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range)

What is being measured

The primary outcome is the main question the study is designed to answer.

Venous Sinus Pressures
Measured: Baseline
Venous Sinus Pressures
Measured: After intervention, up to 5 minutes

Secondary outcomes (2)

Venous Sinus Diameter
Measured: Baseline
Venous Sinus Diameter
Measured: After Intervention, up to 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jun 201925 Sep 2019

First posted8 Mar 2019
Study start20 Jun 2019
Primary completion25 Sep 2019
Study completion25 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Idiopathic Intracranial HypertensionStudies of the same condition, open and under way.
More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
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 N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03867461
Sponsor's protocol ID: IRB00055942
Status last verified: Apr 2019
First submitted: 6 Mar 2019
Last updated: 12 May 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Satti SR, Leishangthem L, Chaudry MI. Meta-Analysis of CSF Diversion Procedures and Dural Venous Sinus Stenting in the Setting of Medically Refractory Idiopathic Intracranial Hypertension. AJNR Am J Neuroradiol. 2015 Oct;36(10):1899-904. doi: 10.3174/ajnr.A4377. Epub 2015 Aug 6.
PubMed 26251432
Teleb MS, Cziep ME, Lazzaro MA, Gheith A, Asif K, Remler B, Zaidat OO. Idiopathic Intracranial Hypertension. A Systematic Analysis of Transverse Sinus Stenting. Interv Neurol. 2013;2(3):132-143. doi: 10.1159/000357503.
PubMed 24999351
Levitt MR, Albuquerque FC, Gross BA, Moon K, Jadhav AP, Ducruet AF, Crowley RW. Venous sinus stenting in patients without idiopathic intracranial hypertension. J Neurointerv Surg. 2017 May;9(5):512-515. doi: 10.1136/neurintsurg-2016-012405. Epub 2016 May 19.
PubMed 27199383
Ahmed RM, Wilkinson M, Parker GD, Thurtell MJ, Macdonald J, McCluskey PJ, Allan R, Dunne V, Hanlon M, Owler BK, Halmagyi GM. Transverse sinus stenting for idiopathic intracranial hypertension: a review of 52 patients and of model predictions. AJNR Am J Neuroradiol. 2011 Sep;32(8):1408-14. doi: 10.3174/ajnr.A2575. Epub 2011 Jul 28.
PubMed 21799038
West JL, Garner RM, Greeneway GP, Traunero JR, Aschenbrenner CA, Singh J, Wolfe SQ, Fargen KM. Venous waveform morphological changes associated with treatment of symptomatic venous sinus stenosis. J Neurointerv Surg. 2018 Nov;10(11):1108-1113. doi: 10.1136/neurintsurg-2018-013858. Epub 2018 Mar 21.
PubMed 29563210
Fargen KM, Spiotta AM, Hyer M, Lena J, Turner RD, Turk AS, Chaudry I. Comparison of venous sinus manometry gradients obtained while awake and under general anesthesia before venous sinus stenting. J Neurointerv Surg. 2017 Oct;9(10):990-993. doi: 10.1136/neurintsurg-2016-012608. Epub 2016 Sep 15.
PubMed 27634954
Raper DMS, Buell TJ, Chen CJ, Ding D, Starke RM, Liu KC. Intracranial venous pressures under conscious sedation and general anesthesia. J Neurointerv Surg. 2017 Oct;9(10):986-989. doi: 10.1136/neurintsurg-2017-012984. Epub 2017 Mar 30.
PubMed 28360352
West JL, Garner RM, Traunero JR, Wolfe SQ, Fargen KM. Changes in End-Tidal Carbon Dioxide Partial Pressure Alter Venous Sinus Pressure Measurements in Idiopathic Intracranial Hypertension. World Neurosurg. 2018 Dec;120:495-499. doi: 10.1016/j.wneu.2018.09.117. Epub 2018 Sep 26.
PubMed 30266712

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Idiopathic Intracranial Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Measurement of Blood Pressure and End Tidal Carbon Dioxide Content Effects on Venous Sinus Caliber and Pressures in Patients With Idiopathic Intracranial Hypertension Undergoing Stenting
ClinicalTrials.gov ID: NCT03867461
Acronym / sponsor ID: IRB00055942
Conditions: Idiopathic Intracranial Hypertension
Keywords: End-Tidal Carbon Dioxide, Venous Sinus Stenting, Venous Sinus Caliber and Pressures
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Study start: 20 Jun 2019 (actual)
Primary completion: 25 Sep 2019 (actual)
Study completion: 25 Sep 2019 (actual)
First posted: 8 Mar 2019 (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.

The purpose of this study is to further elaborate the role of both arterial blood pressure and end-tidal carbon dioxide concentration on measured venous pressures.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group A	Active comparator	Procedure: Venous Sinus Stenting, Other: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range), Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range)Adult patients determined to be candidates for venous sinus stenting. End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention: For Group A: Initial Recording: Mean Arterial Pressure 60-80 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 100-80 mmHg, End tidal CO2 38-40 mmHg.
Group B	Active comparator	Procedure: Venous Sinus Stenting, Other: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range), Other: Adjustment to Mean Arterial Pressure (60-80 mmHg range)Adult patients determined to be candidates for venous sinus stenting. End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention: For Group B: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 60-80 mmHg, End tidal CO2 38-40 mmHg,
Group C	Active comparator	Procedure: Venous Sinus Stenting, Other: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range), Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range)Adult patients determined to be candidates for venous sinus stenting. End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention: For Group C: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 24-26 mmHg, Subsequent Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg,
Group D	Active comparator	Procedure: Venous Sinus Stenting, Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range), Other: Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range)Adult patients determined to be candidates for venous sinus stenting. End tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention: For Group D: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 100-100 mmHg, End tidal CO2 24-24 mmHg,

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adults determined to be candidates for venous sinus stenting

Key exclusion criteria (0 listed)

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
Venous Sinus StentingVenous sinus stenting is performed under general anesthesia. Patients are loaded with aspirin and clopidogrel before the procedure. After induction, the right femoral vein is accessed and an 8 F sheath is placed. Intravenous heparin is administered. A 0.070-0.088 guide catheter is navigated into the ipsilateral jugular vein near the jugular bulb. Pre-stenting manometry is performed in every patient. To do so, a Renegade Hi-Flo microcatheter is navigated into the superior sagittal sinus and then used to measure ipsilateral venous pressures across the site of outflow obstruction (this will be the time point where the study intervention will be performed).	Procedure or surgery	Group A, Group B, Group C, Group D
Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)End-tidal carbon dioxide concentrations will be adjusted to fall in the End-tidal carbon dioxide concentrations will be adjusted to fall in the 38-40 mmHg range	Other	Group A, Group B, Group C
Adjustment to Mean Arterial Pressure (100-110 mmHg range)Mean arterial pressure will be adjusted to fall in the 100-110 mmHg range	Other	Group A, Group C, Group D
Adjustment to Mean Arterial Pressure (60-80 mmHg range)Mean arterial pressure will be adjusted to fall in the 60-80 mmHg range	Other	Group B
Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range)End-tidal carbon dioxide concentrations will be adjusted to fall in the 24-26 mmHg range	Other	Group D

Primary outcome

Venous Sinus Pressures
Time frame: Baseline
Venous Sinus Pressures
Time frame: After intervention, up to 5 minutes

2 secondary outcomes

Venous Sinus Diameter
Time frame: Baseline
Venous Sinus Diameter
Time frame: After Intervention, up to 5 minutes

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
Background: PubMed 26251432Satti SR, Leishangthem L, Chaudry MI. Meta-Analysis of CSF Diversion Procedures and Dural Venous Sinus Stenting in the Setting of Medically Refractory Idiopathic Intracranial Hypertension. AJNR Am J Neuroradiol. 2015 Oct;36(10):1899-904. doi: 10.3174/ajnr.A4377. Epub 2015 Aug 6.
Background: PubMed 24999351Teleb MS, Cziep ME, Lazzaro MA, Gheith A, Asif K, Remler B, Zaidat OO. Idiopathic Intracranial Hypertension. A Systematic Analysis of Transverse Sinus Stenting. Interv Neurol. 2013;2(3):132-143. doi: 10.1159/000357503.
Background: PubMed 27199383Levitt MR, Albuquerque FC, Gross BA, Moon K, Jadhav AP, Ducruet AF, Crowley RW. Venous sinus stenting in patients without idiopathic intracranial hypertension. J Neurointerv Surg. 2017 May;9(5):512-515. doi: 10.1136/neurintsurg-2016-012405. Epub 2016 May 19.
Background: PubMed 21799038Ahmed RM, Wilkinson M, Parker GD, Thurtell MJ, Macdonald J, McCluskey PJ, Allan R, Dunne V, Hanlon M, Owler BK, Halmagyi GM. Transverse sinus stenting for idiopathic intracranial hypertension: a review of 52 patients and of model predictions. AJNR Am J Neuroradiol. 2011 Sep;32(8):1408-14. doi: 10.3174/ajnr.A2575. Epub 2011 Jul 28.
Background: PubMed 29563210West JL, Garner RM, Greeneway GP, Traunero JR, Aschenbrenner CA, Singh J, Wolfe SQ, Fargen KM. Venous waveform morphological changes associated with treatment of symptomatic venous sinus stenosis. J Neurointerv Surg. 2018 Nov;10(11):1108-1113. doi: 10.1136/neurintsurg-2018-013858. Epub 2018 Mar 21.
Background: PubMed 27634954Fargen KM, Spiotta AM, Hyer M, Lena J, Turner RD, Turk AS, Chaudry I. Comparison of venous sinus manometry gradients obtained while awake and under general anesthesia before venous sinus stenting. J Neurointerv Surg. 2017 Oct;9(10):990-993. doi: 10.1136/neurintsurg-2016-012608. Epub 2016 Sep 15.
Background: PubMed 28360352Raper DMS, Buell TJ, Chen CJ, Ding D, Starke RM, Liu KC. Intracranial venous pressures under conscious sedation and general anesthesia. J Neurointerv Surg. 2017 Oct;9(10):986-989. doi: 10.1136/neurintsurg-2017-012984. Epub 2017 Mar 30.
Background: PubMed 30266712West JL, Garner RM, Traunero JR, Wolfe SQ, Fargen KM. Changes in End-Tidal Carbon Dioxide Partial Pressure Alter Venous Sinus Pressure Measurements in Idiopathic Intracranial Hypertension. World Neurosurg. 2018 Dec;120:495-499. doi: 10.1016/j.wneu.2018.09.117. Epub 2018 Sep 26.
Individual participant dataSharing planned: No

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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.

Kyle Fargen, MD principal investigator

Wake Forest University Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 0 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: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Venous Sinus Pressures (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03867461, which also lists 8 linked publications.

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 12 May 2020.