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Ultrasound Measurement of Reactive Hyperemia in Critical Care (URHC)

This study is not yet open for participant recruitment.
Verified July 2012 by University of Rochester
Sponsor:
Information provided by (Responsible Party):
Anthony P. Pietropaoli, University of Rochester
ClinicalTrials.gov Identifier:
NCT01726595
First received: July 6, 2012
Last updated: November 28, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition
Severe Sepsis
Critical Illness

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasound Measurement of Reactive Hyperemia in Critical Care: Prognostic and Pathophysiologic Significance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • hospital mortality [ Time Frame: vital status at hospital discharge, an expected average of 3 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood and urine specimens will be obtained within 48 hours of diagnosis of severe sepsis or severe non-infectious systemic inflammatory response syndrome. Subsequent blood and urine samples will be obtained 3-5 days after the first set of samples, within 48 hours of ICU discharge, and within 48 hours of hospital discharge. Samples will analyzed immediately or stored at -80 degrees celsius until use.


Estimated Enrollment: 252
Study Start Date: January 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria

  • Critically ill patients:

    1. Refusal of patient or designated surrogate decision-maker to provide written informed consent, or inability to obtain consent within 48 hours of diagnosis
    2. Attending physician refusal
    3. Hematocrit (Hct) < 21%
    4. Acute bleeding requiring PRBC transfusion
    5. History of chronic, dialysis dependent renal failure
    6. End-stage liver disease and Child-Pugh Grade C
    7. History of organ, bone marrow, or stem cell transplant
    8. Pregnancy
    9. Cardiac surgery (including ventricular assist device prior to first sample collection)
    10. Do not resuscitate at screening or plans for withdrawal of life support imminent
    11. Suicide attempt or intentional drug overdose;
    12. Jehovah's witness

  • Healthy Control subjects:

    1. Absent doppler signal in brachial or radial arteries.
    2. Asymmetric cyanosis, poor capillary refill or cold temperature
    3. Known venous thrombosis or there is asymmetric swelling (arm circumference > 2 inches larger than opposite side).
    4. Evidence of inflammation or impaired skin integrity of the involved limb.
    5. History of surgery involving the blood or lymphatic vessels of this limb, including axillary lymph node dissection, will preclude this testing.
    6. History of Anemia or G6PD deficiency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726595

Contacts
Contact: Kathleen L. Falkner, R.N., B.S.N. (585) 276-3144 Kathleen_Falkner@urmc.rochester.edu

Locations
United States, New York
University of Rochester Medical Center Not yet recruiting
Rochester, New York, United States, 14642
Contact: Kathleen L. Falkner, R.N., B.S.N.     585-276-3144     Kathleen_Falkner@urmc.rochester.edu    
Sub-Investigator: Orren Wexler, M.D.            
Sub-Investigator: Rodel Banal, M.D.            
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Anthony P. Pietropaoli, M.D., M.P.H. University of Rochester
  More Information

Publications:

Responsible Party: Anthony P. Pietropaoli, Associate Professor of Medicine, University of Rochester
ClinicalTrials.gov Identifier: NCT01726595     History of Changes
Other Study ID Numbers: 00030546
Study First Received: July 6, 2012
Last Updated: November 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
critical care
severe sepsis
microvascular function
ultrasound

Additional relevant MeSH terms:
Critical Illness
Hyperemia
Sepsis
Disease Attributes
Pathologic Processes
 Vascular Diseases
Cardiovascular Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on May 16, 2013