Sepsis, Septic Shock
Conditions
Keywords
sepsis, apigenin, septic shock
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
Interventions
OTHERapigenin
Intragastric tube injection of ground apigenin tablet 50 mg with 5 ml of sterilized water + conventional standardized treatment, for 4 consecutive days.
OTHERsterilized water
Intragastric tube injection of 5 ml of sterilized water + conventional standardized treatment, for 4 consecutive days.
Sponsors
Zhujiang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single(Participant)
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 96-hour Sequential Organ Failure Assessment (SOFA) score | The outcome will be assessed at the 0,1,2,3,4 day after enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| inflammatory response(1) | The outcome will be assessed at the 0,1,2,3,4 day after enrollment | the serum level of C-reactive protein(CRP) |
| inflammatory response(2) | The outcome will be assessed at the 0,1,2,3,4 day after enrollment | the serum level of interleukin-6(IL-6) |
| Duration of use of vasoactive drugs | The outcome will be assessed at the 0,1,2,3,4 day after enrollment | 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) |
| liver function(1) | The outcome will be assessed at the 0,1,2,3,4 day after enrollment | the serum level of Alanine transaminase(ALT) |
| liver function(2) | The outcome will be assessed at the 0,1,2,3,4 day after enrollment | the serum level of Aspartate transaminase (AST) |
| liver function(3) | The outcome will be assessed at the 0,1,2,3,4 day after enrollment | the serum level of total bilirubin(TBil) |
| lung function | The outcome will be assessed at the 0,1,2,3,4 day after enrollment | oxygenation index(PaO2/FiO2),the patients treated with extracorporeal membrane oxygenation will not collect this indicator |
| kidney function(1) | The outcome will be assessed at the 0,1,2,3,4 day after enrollment | serum level of Creatinine (Cr) |
| fluid balance | The outcome will be assessed at the 1,2,3,4 day after enrollment | Net fluid intake and output in 24 hours |
| The length of ICU stay | The outcome will be assessed at the 28 day after enrollment | ICU length of ICU stay |
| kidney function(2) | The outcome will be assessed at the 0,1,2,3,4 day after enrollment | serum level of blood urea nitrogen(BUN) |
| Indicators of infection | The outcome will be assessed at the 0,1,2,3,4 day after enrollment | the serum level of procalcitonin(PCT) |
| The level of lactate | The outcome will be assessed at the 0,1,2,3,4 day after enrollment | the serum level of lactic acid |
| The Duration of use of mechanical ventilation (MV) | The outcome will be assessed at the 28 day after enrollment | 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 duration of CRRT | The outcome will be assessed at the 28 day after enrollment | The duration of CRRT therapy in hours |
| Daily urine output | The outcome will be assessed at the 1,2,3,4 day after enrollment | Daily urine output in milliliters from 0:00 - 24:00 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | The outcome will be assessed at the 28 day after enrollment | 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. |
| Incidence of serious adverse events | The outcome will be assessed at the 28 day after enrollment | 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. |
Countries
China
Outcome results
None listed