Digital Ischemia Reduction in Critically Ill Patients

Not Applicable

Withdrawn

• Conditions: Digital Ischemia; Cardiogenic Shock; Hypovolemic Shock
• Interventions: Device: the combined use of vacuum assisted suction and heat exchanger warming

• Registration Number: NCT05661773
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-22
• Status Verified: 2023-06
• Last Update Submitted: 2023-10-30
• Study Start: 2023-11
• Last Update Posted: 2023-11-01
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combined use of vacuum assisted suction and heat exchanger warming	the combined use of vacuum assisted suction and heat exchanger warming	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.

Primary Outcome Measures

Name	Time	Method
Incidence of digital ischemia	Day 14	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

Secondary Outcome Measures

Name	Time	Method
extent of digital ischemia - length of digits involved	Day 14	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)
extent of digital ischemia - number of digits involved	Day 14	extent of digital ischemia - determined by number of digits involved