Improvement of Organ Function by Apigenin in Elderly Patients With Sepsis

Zhujiang Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Septic Shock; Sepsis

Treatments: Other: sterilized water; Other: apigenin

Study type: Interventional

Funder types: Other

Identifiers

NCT05999682

2023-KY-085-03

Details and patient eligibility

About

In this single-center, randomized, single-blind, placebo-controlled pilot clinical trial. The effect of apigenin on the improvement of organ function will be investigated in elderly patients with sepsis. Researchers will screen patients admitted to the Department of Critical Care Medicine at Zhujiang Hospital to identify patients with sepsis based on including and excluding criteria and obtain informed consent and randomize them into groups. The treatment group will be given apigenin tablets 50mg ground with 5ml of sterilized water for intra-gastric tube injection; the control group will be given an equal volume of sterilized water for intra-gastric tube injection. The changes in SOFA score and other clinically meaningful outcomes in 4 days will be collected.

Full description

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:

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

   Secondary endpoints:

2. The state of inflammatory response: the serum level of interleukin-6(IL-6) and C-reactive protein (CRP) at 96 h after randomization.

3. The state of liver function: the serum level of transaminase (AST#ALT) #total bilirubin at 96 h after randomization.

4. The state of lung function: oxygenation index (PaO2/FiO2) at 96h after Randomization.

5. The state of kidney function: the serum level of Creatinine (Cr)#blood urea nitrogen (BUN)# at 96 h after randomization.

6. The state of infection: the serum level of procalcitonin (PCT) at 96 h after randomization.

7. The state of circulation system: the serum level of lactate at 96 h after Randomization.

8. The duration of successful cessation of supportive therapies for organ dysfunction including vasoactive agents, mechanical ventilation.

9. The daily urine output#duration of continuous renal replacement therapy (CRRT) #fluid balance.

10. The length of stay in ICU.

Safety endpoints:

1. adverse events
2. Serious adverse events

Enrollment: 20 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

apigenin

Experimental group

Description:

Intragastric tube injection of ground apigenin tablet 50 mg with 5 ml of sterilized water + conventional standardized treatment, for 4 consecutive days.

Treatment:

Other: apigenin

sterilized water

Placebo Comparator group

Description:

Gastric tube injection of 5 ml of sterilized water for injection + conventional standardized treatment, for 4 consecutive days.

Treatment:

Other: sterilized water