Hypovolemic ShockDIRNCT05661773
Digital Ischemia Reduction in Critically Ill Patients
A study testing the combined use of vacuum assisted suction and heat exchanger warming in people with Hypovolemic Shock and Cardiogenic Shock, run by Wake Forest University Health Sciences.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypovolemic Shock, Cardiogenic Shock, Digital Ischemia
- What is being tested?
- the combined use of vacuum assisted suction and heat exchanger warming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in the cardiac critical care unit/cardiovascular intensive care unit with cardiac pathologies on vasopressor support
Who cannot join
- Patients who are not on vasopressor support
- Patients under the age of 18
About this study
Official title: Assessing the Effect of Vacuum Suction on Digital Ischemia in Critically Ill Patients
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.
Read the 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.
- Conditions
- Hypovolemic Shock, Cardiogenic Shock, Digital Ischemia
- Being tested
- the combined use of vacuum assisted suction and heat exchanger warming
- Medical subject headings
- Shock, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the combined use of vacuum assisted suction and heat exchanger warmingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 14
Secondary outcomes (2)
extent of digital ischemia - number of digits involved
extent of digital ischemia - determined by number of digits involved
Measured: Day 14
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)
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study startNov 2023 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Why it stopped: FDA required a new investigational device disclosure for using the wound vac in a new way
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypovolemic ShockStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bartlomiej Imielski, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661773
- Sponsor's protocol ID
- IRB00089927
- Acronym
- DIR
- Status last verified
- Jun 2023
- First submitted
- 14 Dec 2022
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of Vacuum Suction on Digital Ischemia in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT05661773
- Acronym / sponsor ID
- DIR / IRB00089927
- Conditions
- Hypovolemic Shock, Cardiogenic Shock, Digital Ischemia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: FDA required a new investigational device disclosure for using the wound vac in a new way
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| combined use of vacuum assisted suction and heat exchanger warming | Experimental | Device: the combined use of vacuum assisted suction and heat exchanger warmingThe 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 | No intervention | –expectant medical management will continue to the contralateral hand |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in the cardiac critical care unit/cardiovascular intensive care unit with cardiac pathologies on vasopressor support
Key exclusion criteria (2 listed)
- Patients who are not on vasopressor support
- Patients under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the combined use of vacuum assisted suction and heat exchanger warmingHeat 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 | combined use of vacuum assisted suction and heat exchanger warming |
Primary outcome
Incidence of digital ischemia
Time frame: 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
2 secondary outcomes
extent of digital ischemia - number of digits involved
Time frame: Day 14
extent of digital ischemia - length of digits involved
Time frame: Day 14
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bartlomiej Imielski, MD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing the combined use of vacuum assisted suction and heat exchanger warming in people with Hypovolemic Shock and Cardiogenic Shock, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of digital ischemia (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.