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Digital Ischemia Reduction in Critically Ill Patients (DIR)

Primary Purpose

Hypovolemic Shock, Cardiogenic Shock, Digital Ischemia

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
the combined use of vacuum assisted suction and heat exchanger warming
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypovolemic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

combined use of vacuum assisted suction and heat exchanger warming

expectant medical management

Arm 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.

expectant medical management will continue to the contralateral hand

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

extent of digital ischemia - number of digits involved
extent of digital ischemia - determined by number of digits involved
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)

Full Information

First Posted
December 14, 2022
Last Updated
August 30, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05661773
Brief Title
Digital Ischemia Reduction in Critically Ill Patients
Acronym
DIR
Official Title
Assessing the Effect of Vacuum Suction on Digital Ischemia in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Suspended
Why Stopped
The reason for suspending the study is the current lack of research infrastructure, primarily a research coordinator. Email dated 23JUN23
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovolemic Shock, Cardiogenic Shock, Digital Ischemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
combined use of vacuum assisted suction and heat exchanger warming
Arm Type
Experimental
Arm 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.
Arm Title
expectant medical management
Arm Type
No Intervention
Arm Description
expectant medical management will continue to the contralateral hand
Intervention Type
Device
Intervention Name(s)
the combined use of vacuum assisted suction and heat exchanger warming
Intervention Description
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 Measure Information:
Title
Incidence of digital ischemia
Description
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
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
extent of digital ischemia - number of digits involved
Description
extent of digital ischemia - determined by number of digits involved
Time Frame
Day 14
Title
extent of digital ischemia - length of digits involved
Description
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)
Time Frame
Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bartlomiej Imielski, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Digital Ischemia Reduction in Critically Ill Patients

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