Improvement of Organ Function by Apigenin in Elderly Patients With Sepsis

NCT05999682 | Completed Phase 1 DMC

• 1 other identifier: 2023-KY-085-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Septic Shock

Keywords

sepsis; apigenin; septic shock

Outcome Measures

Primary Outcomes (1)

• 96-hour Sequential Organ Failure Assessment (SOFA) score

  The SOFA score is the Sequential Organ Failure Score, which is used to assess a patient's prognosis by determining the degree of impairment of major organ function. The score is divided into 6 sections: respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal, and ranges from 0 to 4, with higher SOFA scores associated with a higher incidence of poor prognosis.

  The outcome will be assessed at the 0,1,2,3,4 day after enrollment

Secondary Outcomes (16)

• inflammatory response(1)

  The outcome will be assessed at the 0,1,2,3,4 day after enrollment

• inflammatory response(2)

  The outcome will be assessed at the 0,1,2,3,4 day after enrollment

• Duration of use of vasoactive drugs

  The outcome will be assessed at the 0,1,2,3,4 day after enrollment

• liver function(1)

  The outcome will be assessed at the 0,1,2,3,4 day after enrollment

• liver function(2)

  The outcome will be assessed at the 0,1,2,3,4 day after enrollment

Other Outcomes (2)

• Incidence of adverse events

  The outcome will be assessed at the 28 day after enrollment

• Incidence of serious adverse events

  The outcome will be assessed at the 28 day after enrollment

Study Arms (2)

apigenin

EXPERIMENTAL

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

Other: apigenin

sterilized water

PLACEBO COMPARATOR

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

Other: sterilized water

Interventions

apigenin OTHER

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

apigenin

sterilized water OTHER

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

sterilized water

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

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

Guanzhou, Guangdong, China

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Apigenin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Zhanguo Liu, M.D.PhD

  Department of Critical Care Medicine of Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single(Participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of critical care medicine, Principal Investigator

Model Details: Treatment group: Intragastric tube injection of ground apigenin tablet 50 mg with 5 ml of sterilized water + conventional standardized treatment, for 4 days or ICU discharge. Control group: Intragastric tube injection of 5 ml of sterilized water + conventional standardized treatment, for 4 days or ICU discharge.

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 21, 2023
• Study Start: September 1, 2023
• Primary Completion: January 5, 2024
• Study Completion: January 5, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

CN (1)