Mitigating Cephalad Fluid Shifts: A NSBRI Study

Completed · Not applicable

Conditions studied: Intracranial Pressure

In brief

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.

Key facts

Study ID

NCT03097523

Run by

Saint John's Cancer Institute

People needed

3

Starts

2017-01-01

Expected to finish

2017-05-31

Last updated by the study team

2017-08-16

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• John Wayne Cancer Institute at Providence Saint John's Health Center — Santa Monica, California, United States

Full record on ClinicalTrials.gov

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