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 @ 12:12 PM
Ignite Modification Date:
2025-12-24 @ 12:12 PM
NCT ID:
NCT03256461
Eligibility Criteria:
Inclusion Criteria:
* Older than 17 years old.
* Primary diagnosis is sepsis, means being confirmed or suspected infection while have at least 2 points of quickSOFA(qSOFA).
* Be transferred to intensive care unit (ICU) for the first time during this hospitalization.
* Elevated lactate ≥3.0mmol/L.
Exclusion Criteria:
* Acute hemorrhage uncontrolled.
* Pregnancy.
* Known liver disease - Child-Pugh classes C, acute hepatic failure, severe hepatopathy accompany with prominent portal hypertension.
* Known being in an immunosuppressive state:
1. Suffering from any disease that is unrelated with sepsis that severely inhibits the immune to infection, such as: active hematological or lymphoma malignancy, or during immunosuppressive therapy, such as chemotherapy or radiotherapy.
2. Known human immunodeficiency virus (HIV) serology positive.
* Known chronic kidney disease.
* Suffering from any disease that affects lactate kinetics, such as mitochondrial encephalopathy, congenital hyperlipidemia, Wernicke encephalopathy, etc. Or other probable cause of hyperlactatemia.
* Took any drugs that affect lactate kinetics within the effective time window, such as taking metformin or phenylephrine within 1 week.
* Suffering from any disease that restricts resuscitation, such as heart failure, cardiac surgery, severe heart disease etc, or suffered from a cardio-pulmonary resuscitation,.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03256461
Study Brief:
Protocol Section:
NCT03256461