Mitigating Cephalad Fluid Shifts: A NSBRI Study

NCT ID: NCT03097523

Last Updated: 2017-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2017-05-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Custom Thigh Cuff

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Space Biomedical Research Institute

OTHER

Sponsor Role: collaborator

Saint John's Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Santosh Kesari, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Saint John's Cancer Institute

Locations

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

Santa Monica, California, United States

Countries

United States

Other Identifiers

JWCI-16-0501

Identifier Type: -

Identifier Source: org_study_id