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Mitigating Cephalad Fluid Shifts: A NSBRI Study (NSBRI)

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ClinicalTrials.gov Identifier: NCT03097523
Recruitment Status : Completed
First Posted : March 31, 2017
Last Update Posted : August 16, 2017
Sponsor:
Collaborator:
National Space Biomedical Research Institute
Information provided by (Responsible Party):
John Wayne Cancer Institute

Brief Summary:
This is a feasibility study to determine optimal thigh cuff design using a cephalad fluid shift protocol in patients who have an intraventricular catheter (such as Ommaya reservoir) placed for the delivery of central nervous system chemotherapy or for diagnosing potential elevation of ICP and monitoring its progression as part of standard medical care.

Condition or disease Intervention/treatment Phase
Intracranial Pressure Device: Custom Thigh Cuff Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Validation of a Cephalad Fluid Shift Countermeasure: Selection of Optimal Thigh Cuff Design Followed by Intracranial Pressure (ICP) Measurements During Extended Thigh Cuff Application
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Arm Intervention/treatment
Experimental: Study Arm

Patients with intraventricular catheter meeting eligibility criteria will undergo the following procedures:

  • Blood pressure, heart rate, electrocardiogram and Intracranial Pressure (ICP) monitoring after standard of care procedures are completed
  • Continuous ICP monitoring using a disposable pressure transducer (i.e., TruWaveTM)
  • Sequential placement in an upright, seated, supine 0°, and supine 15° head down tilt (HDT) positions for approximately 15 minutes for stabilization, followed by: Non-invasive ICP, intra-ocular pressure (IOP) assessment, femoral vascular ultrasound, jugular vascular ultrasound, and assessment of adverse events
Device: Custom Thigh Cuff
The aim is to achieve positive and near normal forward arterial vascular blood flow to the lower extremities. Milder cuff pressures up to 65 mmHg will be used to limit venous return to the upper body.




Primary Outcome Measures :
  1. Changes in intracranial pressure using cerebral and cochlear fluid pressure (CCFP) analyser and a disposable pressure transducer [ Time Frame: 20 minutes ]
    Noninvasive and invasive ICP monitoring following standard of care procedures requiring access to ventricular catheter



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, 18-89 years old
  • Willing and able to provide informed consent
  • Patients who have an intraventricular catheter placed for the delivery of central nervous system chemotherapy or for diagnosing potential elevation of ICP and monitoring its progression as part of standard medical care
  • KPS ≥ 70
  • For patients on active anti-cancer (intra-thecal or IV) therapy, must be at least 2 weeks since last treatment; oral therapy is permitted

Exclusion Criteria:

  • Less than 2 weeks since any prior surgery
  • ICP > 20 mmHg that cannot be clinically stabilized
  • Pregnant (Note: women of child-bearing potential must have a negative urine pregnancy test; women who are not of child-bearing potential are defined as: post-menopausal, age > 55 years with cessation of menses for 12 or more months; or less than 55 years with postmenopausal status confirmed by follicle-stimulating hormone in the post-menopausal range; or who have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)
  • Existing cardiovascular disease, diabetes, syncope, ocular disease that, in the opinion of the investigator, may confound the study results
  • Uncontrolled neurological symptoms such as headache, nausea or vomiting that, in the opinion of the investigator, will limit the patient's ability to participate in the study
  • Injury, trauma, venous thromboembolism, peripheral arterial disease or any condition that, in the opinion of the investigator, will prevent the subject from tolerating the application of a thigh cuff; history of treated DVT is permitted

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03097523


Locations
United States, California
John Wayne Cancer Institute at Providence Saint John's Health Center
Santa Monica, California, United States, 90404
Sponsors and Collaborators
John Wayne Cancer Institute
National Space Biomedical Research Institute
Investigators
Principal Investigator: Santosh Kesari, MD, PhD John Wayne Cancer Institute

Responsible Party: John Wayne Cancer Institute
ClinicalTrials.gov Identifier: NCT03097523     History of Changes
Other Study ID Numbers: JWCI-16-0501
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data transfers or sharing is restricted to those JWCI study personnel identified on the site delegation log and/or per data use agreements. Data will be provided to the study sponsor.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by John Wayne Cancer Institute:
NSBRI