Mitigating Cephalad Fluid Shifts: A NSBRI Study

Intracranial Pressure Clinical Trial

— NSBRI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097523
• Other study ID #: JWCI-16-0501
• Status: Completed
• Phase: N/A
• First received: March 27, 2017
• Last updated: August 14, 2017
• Start date: January 1, 2017
• Est. completion date: May 31, 2017

Study information

• Verified date: August 2017
• Source: John Wayne Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Intracranial Pressure

Intervention

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.

Locations

Country	Name	City	State
United States	John Wayne Cancer Institute at Providence Saint John's Health Center	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
John Wayne Cancer Institute	National Space Biomedical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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