Digital Ischemia Reduction in Critically Ill Patients (DIR)

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Digital Ischemia; Hypovolemic Shock; Cardiogenic Shock

Treatments: Device: the combined use of vacuum assisted suction and heat exchanger warming

Study type: Interventional

Funder types: Other

Identifiers

NCT05661773

IRB00089927

Details and patient eligibility

About

Patients requiring high dose pressors (minimum 2) who are unlikely to be weaned off them over 1 day will be identified. Patients will have the device applied to one hand while expectant medical management will continue to the contralateral hand.

Full description

The proposed study offers no foreseeable risk to patients. The device relies on a wound vac system for vacuum generation which is industry standard and approved for creating safe suction applied to wounds. In this application, the same suction and device would be used to apply suction to an enclosure through which the hand is placed. Similarly, a heat exchanger would be used to run lukewarm water through a warming bad, which is technology that is routinely used in surgery. Heater coolers are used in every bypass surgery, and warming fluid blankets are common for helping to rewarm patients on the operating room table.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients in the cardiac critical care unit/cardiovascular intensive care unit with cardiac pathologies on vasopressor support

Exclusion criteria

• Patients who are not on vasopressor support
• Patients under the age of 18

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

combined use of vacuum assisted suction and heat exchanger warming

Experimental group

Description:

The novel idea that this study proposes, is the combined use of vacuum assisted suction and heat exchanger warming. It is well known that heat causes capillary vasodilation, where warming hands and toes improves blood flow while cooling them causes vasoconstriction. Applying a vacuum across a capillary bed increases the transcapillary gradient increasing the driving force of blood flow into tissues. The combination of these two mechanisms can work synchronously to improve blood flow to ischemic extremities and digits.

Treatment:

Device: the combined use of vacuum assisted suction and heat exchanger warming

expectant medical management

No Intervention group

Description:

expectant medical management will continue to the contralateral hand