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:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT03853005
Eligibility Criteria:
Inclusion Criteria:
1. ≥ 18 years
2. Severe sepsis defined by Quick SOFA score by presentation of 2 or more of the following criteria:
* Mental clouding: decreased glasco coma scale GCS \< 15
* Hypotension: Systolic blood pressure \< 100 mmgH
* Tachypnea: respiratory rate \> 22 breath/ minute Then serum lactate is analysed to confirm sepsis hypoperfusion if ≥ 2mmol/L
3. Organs dysfunction (including one of them respiratory failure).
Organ dysfunctions are defined as following:
Respiratory dysfunction (criteria for ARDS):
* PaO2/FiO2 \<200
* Bilateral infiltrates in chest X-ray
* Resistant hypoxemia
* Tachypnoea (RR \> 40 breath/minute)
* The need for invasive mechanical ventilation
* Excluded cardiac causes of pulmonary edema
CNS failure:
* Decreased GCS ≥ 4 decreased points
CVS dysfunction:
* Sustained hypotension even on very high inotropes doses (Noradrenaline \>1µm/min)+ adrenaline\>1.5µm/min associated
* with high CVP pressure \> 12 mmHg and not responding to fluid challenge test to exclude hypovolemia.
* Cardiomegaly detected by either echocardiography assessment, or chest X-ray
* Resistant frequent ventricular ectopics not explained by organic causes.
Liver dysfunction:
* Elevated total and direct bilirubin than double normal or basal levels
* Elevated prothrombin time \> 17 seconds or INR \> 1.5
* Elevated liver enzymes \> triple normal level
Renal dysfunction:
* Decreased urine output \< 0.5 ml/kg.
* Elevated creatinine level \> 164 µmol/L (1.5mg/dL).
* Decreased creatinine clearance \<50ml/minute if available.
Bone marrow depression:
* Decreased platelets \< 90 X 103/µL
* Decreased leukocytes \<4 X 103/µL
* Decreased RBCs count \< 4 X 106/µL
Exclusion Criteria:
1. Patient relatives' refusal
2. Pregnancy
3. Recent active internal hemorrhage
4. Not mechanically ventilated.
5. Hypersensitivity to the dialyser fluid
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03853005
Study Brief:
Protocol Section:
NCT03853005