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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT01087450
Eligibility Criteria:
Inclusion Criteria:
* The patients must be 18 years old and over to be included in the study. They must meet criteria for sepsis defined as:40
1. Two or more criteria for the systemic inflammatory response syndrome (SIRS):
* heart rate greater than 90 beats per minute, or paced, or taking beta-blockers or the calcium channel blockers verapamil or diltiazem
* respiratory rate greater than 20 breathes per minute, or a PaC02 less than 32 mmHg, or mechanically ventilated
* temperature greater than 38 or less than 36 degrees Celsius
* white blood cell count greater than 12 x 109/L or less than 4 x 109/L, or more than 10% bands on the differential.
2. Suspected or confirmed source of infection
And either one of the following definitions:
3. Severe Sepsis: Sepsis with at least one organ dysfunction defined as urine output \< 0.5 ml/kg/hr for 1 hour, PaO2/FiO2 \< 250 (less than 200 if lung is the only dysfunctional organ), platelets \< 80 x109/L or a 50% decrease from baseline in the past 3 days, or pH \< 7.30 or lactate \> 1.5 mmole/L upper normal with base deficit \> 5
4. Septic shock \<48hrs: Persistent arterial hypotension with a systolic pressure \< 90 mmHg or a MAP \< 60 mmHg or a reduction of in systolic blood pressure \> 40 mmHg from baseline, despite adequate fluid resuscitation in the absence of other cause for hypotension or requiring the administration of a pressor agent to maintain the above blood pressure.
Exclusion Criteria:
* Clinically apparent other forms of shock including cardiogenic, obstructive (massive pulmonary embolism, cardiac tamponade, tension pneumothorax) or hemorrhagic shock
* A known previous severe reaction to erythropoietin
* Uncontrolled hypertension (hypertensive urgency, hypertensive emergency and hypertensive encephalopathy)
* Myocardial infarction and/or stroke within one month
* Hypersensitivity reaction after previous rh-EPO use. Known sensitivity to products from mammalian cell cultures
* Previous history of deep venous thromboses or pulmonary embolism
* Burns
* Cirrhosis
* Traumatic brain injury
* Less than 18 years of age
* Family or patient not committed to aggressive care
* Currently enrolled in another related interventional study
* Any active cancer patients of any type and stage except for patients with basal and squamous cell skin cancers
* Patient weighing \> 100 kg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01087450
Study Brief:
Protocol Section:
NCT01087450