Digital Ischemia Reduction in Critically Ill Patients

Cardiogenic Shock Clinical Trial

— DIR  

Official title:

Assessing the Effect of Vacuum Suction on Digital Ischemia in Critically Ill Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05661773
• Other study ID #: IRB00089927
• Status: Withdrawn
• Phase: N/A
• Start date: November 2023
• Est. completion date: November 2024

Study information

• Verified date: June 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Hypovolemia
• Hypovolemic Shock
• Ischemia
• Shock
• Shock, Cardiogenic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of digital ischemia	rate of digital ischemia characterized by tissue loss or destruction - measure incidence rate as a ratio of patients who got digital ischemia with the number of patients who were on vasopressors	Day 14
Secondary	extent of digital ischemia - number of digits involved	extent of digital ischemia - determined by number of digits involved	Day 14
Secondary	extent of digital ischemia - length of digits involved	extent of digital ischemia - determined by degree of length of digits involved (like distal finger joint, proximal finger joint, entire finger, into the palm, etc)	Day 14