Clinical trial NCT05999682: Improvement of Organ Function by Apigenin in Elderly Patients With Sepsis
Official title: Improvement of Organ Function by Apigenin in Elderly Patients With Sepsis: A Single-center, Single-blind, Randomized, Placebo-controlled, Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sepsis
Septic Shock
Keywords: sepsis
apigenin
septic shock
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: 96-hour Sequential Organ Failure Assessment (SOFA) score
timeFrame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
Secondary outcomes:
measure: inflammatory response(1)
timeFrame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
measure: inflammatory response(2)
timeFrame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
measure: Duration of use of vasoactive drugs
timeFrame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
measure: liver function(1)
timeFrame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
measure: liver function(2)
timeFrame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
measure: liver function(3)
timeFrame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
measure: lung function
timeFrame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
measure: kidney function(1)
timeFrame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
measure: kidney function(2)
timeFrame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
measure: Indicators of infection
timeFrame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
measure: The level of lactate
timeFrame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
measure: The Duration of use of mechanical ventilation (MV)
timeFrame: The outcome will be assessed at the 28 day after enrollment
measure: The duration of CRRT
timeFrame: The outcome will be assessed at the 28 day after enrollment
measure: Daily urine output
timeFrame: The outcome will be assessed at the 1,2,3,4 day after enrollment
measure: fluid balance
timeFrame: The outcome will be assessed at the 1,2,3,4 day after enrollment
measure: The length of ICU stay
timeFrame: The outcome will be assessed at the 28 day after enrollment
Other outcomes:
measure: Incidence of adverse events
timeFrame: The outcome will be assessed at the 28 day after enrollment
measure: Incidence of serious adverse events
timeFrame: The outcome will be assessed at the 28 day after enrollment
Locations:
city: Guanzhou
country: China
facility: Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University
state: Guangdong
Study officials:
affiliation: Department of Critical Care Medicine of Zhujiang Hospital
name: Zhanguo Liu, M.D.PhD
role: PRINCIPAL_INVESTIGATOR
References: