Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2025-12-24 @ 1:27 PM
NCT ID:
NCT01726595
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01726595
Study Brief:
Protocol Section:
NCT01726595