Digital Ischemia Reduction in Critically Ill Patients

NCT05661773 | Withdrawn FDA Device

• 1 other identifier: IRB00089927
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypovolemic Shock; Cardiogenic Shock; Digital Ischemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• extent of digital ischemia - number of digits involved

  Day 14

• extent of digital ischemia - length of digits involved

  Day 14

Study Arms (2)

combined use of vacuum assisted suction and heat exchanger warming

EXPERIMENTAL

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.

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

expectant medical management

NO INTERVENTION

expectant medical management will continue to the contralateral hand

Interventions

the combined use of vacuum assisted suction and heat exchanger warming DEVICE

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.

combined use of vacuum assisted suction and heat exchanger warming

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

Shock; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Necrosis

Study Officials

• Bartlomiej Imielski, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each patient will act as their own control. By applying the vacuum assisted warmer to one hand, results can be compared to the contralateral hand. In this way, patient outcomes can be assessed between patients and indexed to each patient.

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 22, 2022
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 1, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share