Mitigating Cephalad Fluid Shifts: A NSBRI Study

NCT03097523 | Completed

• 1 other identifier: JWCI-16-0501
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Pressure

Keywords

NSBRI

Outcome Measures

Primary Outcomes (1)

• Changes in intracranial pressure using cerebral and cochlear fluid pressure (CCFP) analyser and a disposable pressure transducer

  Noninvasive and invasive ICP monitoring following standard of care procedures requiring access to ventricular catheter

  20 minutes

Study Arms (1)

Study Arm

EXPERIMENTAL

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

Interventions

Custom Thigh Cuff DEVICE

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.

Study Arm

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint John's Cancer Institute: lead
• National Space Biomedical Research Institute: collaborator

Study Sites (1)

John Wayne Cancer Institute at Providence Saint John's Health Center

Santa Monica, California, 90404, United States

Location

Study Officials

• Santosh Kesari, MD, PhD

  Saint John's Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: March 31, 2017
• Study Start: January 1, 2017
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: August 16, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)