Improvement of Organ Function by Apigenin in Elderly Patients With Sepsis

Investigational drug: Apigenin Study title: Improvement of Organ function by Apigenin in Elderly Patients With Sepsis: A Single-center, Single-blind, Randomized, Placebo-controlled, pilot Clinical Trial Principal Investigator: Zhanguo Liu, professor, Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University Study subjects: Elderly septic/septic shock patients who meet the diagnostic criteria of the 2016 International Sepsis Guidelines.

Study objectives: The objective of the study is to determine whether apigenin, compared to placebo, improves organ dysfunction scores (SOFA scores) in elderly septic patients.

Study design: A single-center, single-blind, randomized, placebo-controlled pilot Clinical Trial.

Method: Apigenin group: Intragastric tube injection of ground apigenin tablet 50 mg with 5 ml of sterilized water + conventional standardized treatment, for 4 days or until ICU discharge. Placebo control group: Gastric tube injection of 5 ml of sterilized water for injection + conventional standardized treatment, for 4 days or ICU discharge.

Course: 4 days Sample size: 20 The number of study center: 1

Study center:

• Department of Critical Care Medicine of Zhujiang Hospital, Guangzhou, Guangdong, China Primary endpoint: 96-hour Sequential Organ Failure Assessment (SOFA) score

Secondary endpoints:

• The state of inflammatory response: the serum level of interleukin-6(IL-6) and C-reactive protein (CRP) at 96 h after randomization.
• The state of liver function: the serum level of transaminase (AST#ALT) #total bilirubin at 96 h after randomization.
• The state of lung function: oxygenation index (PaO2/FiO2) at 96h after Randomization.
• The state of kidney function: the serum level of Creatinine (Cr)#blood urea nitrogen (BUN)# at 96 h after randomization.
• The state of infection: the serum level of procalcitonin (PCT) at 96 h after randomization.
• The state of circulation system: the serum level of lactate at 96 h after Randomization.
• The duration of successful cessation of supportive therapies for organ dysfunction including vasoactive agents, mechanical ventilation.
• The daily urine output#duration of continuous renal replacement therapy (CRRT) #fluid balance.
• The length of stay in ICU.

Safety endpoints:

• adverse events
• Serious adverse events

Inclusion criteria

• age ≥65 years;
• meeting the diagnostic criteria of the 2016 International Sepsis Guidelines;
• subjects who voluntarily participated in this study and signed an informed consent form.

Exclusion criteria

• patients who are allergic to the study products;
• patients who are unable to feed via gastrointestinal nutrition tube.