Autonomic Control of the Circulation and VDR

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

August 14, 2019

Primary Completion Date

May 1, 2026

Study Completion Date

May 30, 2026

Conditions
Venous Distension ReflexBlood Pressure
Interventions
OTHER

Wrist-to-elbow (W-E) occlusion

"An IV will be inserted in the antecubital fossa of one arm. The arm will be fitted with occlusion cuffs arranged in a continuous fashion from the wrist to the elbow. A final cuff will be placed on the upper arm. The cuffs from the wrist to the elbow will be inflated to the same pressure of up to 300 mmHg using a pressurized air tank.~First, the subject?s arm will be elevated and the subject will make a fist to squeeze blood from the hand. Then the wrist cuff will be inflated. Once that cuff is fully inflated, the next cuff in the sequence will be inflated. Cuffs are inflated in sequence until the elbow cuff is inflated. After a 10-15 second period to allow blood to drain, the upper arm cuff will inflate (up to 250 mmHg) to keep any additional blood from entering the forearm. Next, the cuffs on the forearm will be removed but the upper arm cuff will remain inflated."

DRUG

ketorolac tromethamine

In the COX blockade trial, just after the Wrist-to-elbow occlusion, 6 mg ketorolac tromethamine in 10 ml saline will be infused into the forearm over 1 minute. After 10 minutes, a second infusion of ketorolac tromethamine (up to 3 mg) in 5% of the forearm volume of saline,( \~40-60 ml) will be infused into the occluded forearm at a rate of \~ 30 ml/min. Five minutes of data will then be collected before releasing the upper arm cuff. Infusion 1 is to block the COX pathway, while infusion 2 is to induce venous distension.

DRUG

saline control

In the saline control trial performed on a separate day, saline (without ketorolac) in identical volumes as those in the COX blockade trial, will be infused.

Trial Locations (1)

17033

RECRUITING

Penn State Milton S. Hershey Medical Center, Hershey

All Listed Sponsors
lead

Milton S. Hershey Medical Center

OTHER