Improvement of Organ Function by Apigenin in Elderly Patients With Sepsis

NCT ID: NCT05999682

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-01-05

Brief Summary

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.

Detailed 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

Conditions

Sepsis; Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

apigenin

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

Group Type: EXPERIMENTAL

apigenin

Intervention Type: OTHER

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

sterilized water

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

Group Type: PLACEBO_COMPARATOR

sterilized water

Intervention Type: OTHER

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

Interventions

apigenin

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

Intervention Type: OTHER

sterilized water

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Liu Zhanguo

Director of the department of critical care medicine, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhanguo Liu, M.D.PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Critical Care Medicine of Zhujiang Hospital

Locations

Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University

Guanzhou, Guangdong, China

Countries

China

Other Identifiers

2023-KY-085-03

Identifier Type: -

Identifier Source: org_study_id