Improvement of Organ Function by Apigenin in Elderly Patients With Sepsis

Sepsis Clinical Trial

Official title:

Improvement of Organ Function by Apigenin in Elderly Patients With Sepsis: A Single-center, Single-blind, Randomized, Placebo-controlled, Pilot Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05999682
• Other study ID #: 2023-KY-085-03
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 1, 2023
• Est. completion date: January 5, 2024

Study information

• Verified date: March 2024
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 5, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Shock, Septic
• Toxemia

Intervention

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

Locations

Country	Name	City	State
China	Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University	Guanzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse events	A adverse event refers to any adverse medical event that occur after the intervention of trial. The adverse events are not necessarily causally related to the trial treatment.	The outcome will be assessed at the 28 day after enrollment
Other	Incidence of serious adverse events	Any adverse medical event occurs at any dose that meets one or more of the following criteria: 1. causes death 2.life-threatening 3. requires hospitalization or hospitalization for an extended period of time 4. causes permanent or significant disability and functional defects 5. causes deformity.	The outcome will be assessed at the 28 day after enrollment
Primary	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	inflammatory response(1)	the serum level of C-reactive protein(CRP)	The outcome will be assessed at the 0,1,2,3,4 day after enrollment
Secondary	inflammatory response(2)	the serum level of interleukin-6(IL-6)	The outcome will be assessed at the 0,1,2,3,4 day after enrollment
Secondary	Duration of use of vasoactive drugs	The duration from the vasoactive drugs administration to the successful cessation in hours( The successful cessation is defined as the attainment of a clinician-prescribed mean arterial pressure target for more than 24-hours without the use of vasoactive drugs.This outcome measure is intended only for patients receiving vasoactive drugs)	The outcome will be assessed at the 0,1,2,3,4 day after enrollment
Secondary	liver function(1)	the serum level of Alanine transaminase(ALT)	The outcome will be assessed at the 0,1,2,3,4 day after enrollment
Secondary	liver function(2)	the serum level of Aspartate transaminase (AST)	The outcome will be assessed at the 0,1,2,3,4 day after enrollment
Secondary	liver function(3)	the serum level of total bilirubin(TBil)	The outcome will be assessed at the 0,1,2,3,4 day after enrollment
Secondary	lung function	oxygenation index(PaO2/FiO2),the patients treated with extracorporeal membrane oxygenation will not collect this indicator	The outcome will be assessed at the 0,1,2,3,4 day after enrollment
Secondary	kidney function(1)	serum level of Creatinine (Cr)	The outcome will be assessed at the 0,1,2,3,4 day after enrollment
Secondary	kidney function(2)	serum level of blood urea nitrogen(BUN)	The outcome will be assessed at the 0,1,2,3,4 day after enrollment
Secondary	Indicators of infection	the serum level of procalcitonin(PCT)	The outcome will be assessed at the 0,1,2,3,4 day after enrollment
Secondary	The level of lactate	the serum level of lactic acid	The outcome will be assessed at the 0,1,2,3,4 day after enrollment
Secondary	The Duration of use of mechanical ventilation (MV)	The duration from the MV administration to the successful cessation in hours( The successful cessation is defined as the termination of MV for more than 48-hours. This outcome measure is intended only for patients receiving MV)	The outcome will be assessed at the 28 day after enrollment
Secondary	The duration of CRRT	The duration of CRRT therapy in hours	The outcome will be assessed at the 28 day after enrollment
Secondary	Daily urine output	Daily urine output in milliliters from 0:00 - 24:00	The outcome will be assessed at the 1,2,3,4 day after enrollment
Secondary	fluid balance	Net fluid intake and output in 24 hours	The outcome will be assessed at the 1,2,3,4 day after enrollment
Secondary	The length of ICU stay	ICU length of ICU stay	The outcome will be assessed at the 28 day after enrollment