Severe SepsisURHCNCT01726595
Ultrasound Measurement of Reactive Hyperemia in Critical Care
An observational study of Severe Sepsis and Critical Illness, run by University of Rochester at 1 site in United States.
Trial summary
The investigators hypothesize that doctors and nurses can undergo a brief period of training and then use ultrasound to accurately measure blood flow in a forearm artery after a brief period when this flow is interrupted with a blood pressure cuff, a measurement the investigators call reactive hyperemia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Severe Sepsis, Critical Illness
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2019
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Critically ill Patients: Patients admitted to University of Rochester Medical Center ICU services with 2 of the 4 systemic inflammatory response syndrome (SIRS) criteria and acute organ dysfunction will be considered for enrollment. Healthy Control subjects: Healthy control subjects >= 18 years of age will be recruited from the University and Rochester region at large.
Who may be able to join
- Patients admitted to University of Rochester Medical Center ICU services with 2 of the 4 systemic inflammatory response syndrome (SIRS) criteria and acute organ dysfunction will be considered for enrollment.
- Healthy control subjects >= 18 years of age will be recruited from the University and Rochester region at large.
Who cannot join
- Critically ill patients:
- Refusal of patient or designated surrogate decision-maker to provide written informed consent, or inability to obtain consent within 48 hours of diagnosis
- Attending physician refusal
- Hematocrit (Hct) < 21%
- Acute bleeding requiring PRBC transfusion
- History of chronic, dialysis dependent renal failure
Show all 20Show fewer
- End-stage liver disease and Child-Pugh Grade C
- History of organ, bone marrow, or stem cell transplant
- Pregnancy
- Cardiac surgery (including ventricular assist device prior to first sample collection)
- Do not resuscitate at screening or plans for withdrawal of life support imminent
- Suicide attempt or intentional drug overdose;
- Jehovah's witness
- Healthy Control subjects:
- Absent doppler signal in brachial or radial arteries.
- Asymmetric cyanosis, poor capillary refill or cold temperature
- Known venous thrombosis or there is asymmetric swelling (arm circumference > 2 inches larger than opposite side).
- Evidence of inflammation or impaired skin integrity of the involved limb.
- History of surgery involving the blood or lymphatic vessels of this limb, including axillary lymph node dissection, will preclude this testing.
- History of Anemia or G6PD deficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Ultrasound Measurement of Reactive Hyperemia in Critical Care: Prognostic and Pathophysiologic Significance
The investigators hypothesize that doctors and nurses can undergo a brief period of training and then use ultrasound to accurately measure blood flow in a forearm artery after a brief period when this flow is interrupted with a blood pressure cuff, a measurement the investigators call reactive hyperemia. Reactive hyperemia indicates whether the small blood vessels in the body are healthy -- lower reactive hyperemia indicates worse small blood vessel function. When measured by experienced ultrasound experts, low reactive hyperemia strongly predicts death in critically ill patients with infection (severe sepsis).
The investigators are conducting this study to determine if doctors and nurses, without specific pre-existing expertise in ultrasound, can be trained to make these measurements accurately. If so, the investigators will prove that these measurements can be applied reliably in real-world practice.
Read more
The investigators also hypothesize that reactive hyperemia predict the outcomes of illness not just in patients with severe infection, but in other critically ill patients as well.
Finally, the investigators hypothesize that reduced blood flow after blood pressure cuff occlusion is linked with other abnormalities of blood, previously identified in critically ill patients. For example, red blood cells from patients with severe sepsis have been shown to be stiffer than normal, so they are less able to flow along the small blood vessel passages of the body. Red blood cells become stiffer when there is a certain type of stress in the body known as "oxidative stress."
If the investigators show that low reactive hyperemia, stiff red blood cells, and oxidative stress are linked, the investigators hope to develop new treatments that reduce oxidative stress, reduce the stiffness of red blood cells, and in turn improve reactive hyperemia. Improvements in reactive hyperemia indicate improvements in small blood vessel function. Better small blood vessel function means better delivery of oxygen throughout the body. The investigators believe that this will improve outcomes for critically ill patients.
- Conditions
- Severe Sepsis, Critical Illness
- Keywords
- critical care, severe sepsis, microvascular function, ultrasound
- Medical subject headings
- Sepsis, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| severe sepsis | Patients with severe sepsis or septic shock | |
| non-infected critically ill | Patients with severe non-infectious systemic inflammatory response syndrome | |
| healthy | healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital mortality
Measured: vital status at hospital discharge, an expected average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony P. Pietropaoli, University of Rochester
- Investigators
- Anthony P. Pietropaoli, M.D., M.P.H., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726595
- Sponsor's protocol ID
- 00030546
- Acronym
- URHC
- Status last verified
- Feb 2020
- First submitted
- 6 Jul 2012
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Wexler O, Morgan MA, Gough MS, Steinmetz SD, Mack CM, Darling DC, Doolin KP, Apostolakos MJ, Graves BT, Frampton MW, Chen X, Pietropaoli AP. Brachial artery reactivity in patients with severe sepsis: an observational study. Crit Care. 2012 Dec 12;16(2):R38. doi: 10.1186/cc11223.
PubMed 22390813
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Measurement of Reactive Hyperemia in Critical Care: Prognostic and Pathophysiologic Significance
- ClinicalTrials.gov ID
- NCT01726595
- Acronym / sponsor ID
- URHC / 00030546
- Conditions
- Severe Sepsis, Critical Illness
- Keywords
- critical care, severe sepsis, microvascular function, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 15 Nov 2012 (estimated)
- 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.
The investigators hypothesize that doctors and nurses can undergo a brief period of training and then use ultrasound to accurately measure blood flow in a forearm artery after a brief period when this flow is interrupted with a blood pressure cuff, a measurement the investigators call reactive hyperemia. Reactive hyperemia indicates whether the small blood vessels in the body are healthy -- lower reactive hyperemia indicates worse small blood vessel function. When measured by experienced ultrasound experts, low reactive hyperemia strongly predicts death in critically ill patients with infection (severe sepsis).
The investigators are conducting this study to determine if doctors and nurses, without specific pre-existing expertise in ultrasound, can be trained to make these measurements accurately. If so, the investigators will prove that these measurements can be applied reliably in real-world practice.
The investigators also hypothesize that reactive hyperemia predict the outcomes of illness not just in patients with severe infection, but in other critically ill patients as well.
Finally, the investigators hypothesize that reduced blood flow after blood pressure cuff occlusion is linked with other abnormalities of blood, previously identified in critically ill patients. For example, red blood cells from patients with severe sepsis have been shown to be stiffer than normal, so they are less able to flow along the small blood vessel passages of the body. Red blood cells become stiffer when there is a certain type of stress in the body known as "oxidative stress."
If the investigators show that low reactive hyperemia, stiff red blood cells, and oxidative stress are linked, the investigators hope to develop new treatments that reduce oxidative stress, reduce the stiffness of red blood cells, and in turn improve reactive hyperemia. Improvements in reactive hyperemia indicate improvements in small blood vessel function. Better small blood vessel function means better delivery of oxygen throughout the body. The investigators believe that this will improve outcomes for critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| severe sepsis | – | –Patients with severe sepsis or septic shock |
| non-infected critically ill | – | –Patients with severe non-infectious systemic inflammatory response syndrome |
| healthy | – | –healthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill Patients: Patients admitted to University of Rochester Medical Center ICU services with 2 of the 4 systemic inflammatory response syndrome (SIRS) criteria and acute organ dysfunction will be considered for enrollment. Healthy Control subjects: Healthy control subjects >= 18 years of age will be recruited from the University and Rochester region at large.
Key inclusion criteria (2 listed)
- Patients admitted to University of Rochester Medical Center ICU services with 2 of the 4 systemic inflammatory response syndrome (SIRS) criteria and acute organ dysfunction will be considered for enrollment.
- Healthy control subjects >= 18 years of age will be recruited from the University and Rochester region at large.
Key exclusion criteria (20 listed)
- Critically ill patients:
- Healthy Control subjects:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hospital mortality
Time frame: vital status at hospital discharge, an expected average of 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Background: PubMed 22390813Wexler O, Morgan MA, Gough MS, Steinmetz SD, Mack CM, Darling DC, Doolin KP, Apostolakos MJ, Graves BT, Frampton MW, Chen X, Pietropaoli AP. Brachial artery reactivity in patients with severe sepsis: an observational study. Crit Care. 2012 Dec 12;16(2):R38. doi: 10.1186/cc11223.
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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.
Anthony P. Pietropaoli, M.D., M.P.H. principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis and Critical Illness, run by University of Rochester at 1 site in United States.
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 2 inclusion and 20 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: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
hospital mortality (time frame: vital status at hospital discharge, an expected average of 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01726595, which also lists 1 linked publication.
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 12 Feb 2020.