SepsisPhase 1/2NCT05999682
Improvement of Organ Function by Apigenin in Elderly Patients With Sepsis
A Phase 1/2 study testing apigenin and sterilized water in people with Sepsis and Septic Shock, run by Zhujiang Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- apigenin and sterilized water
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 5 Jan 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- patients who are allergic to the study products;
- patients who are unable to feed via gastrointestinal nutrition tube.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University
Guanzhou, Guangdong
About this study
Official title: Improvement of Organ Function by Apigenin in Elderly Patients With Sepsis: A Single-center, Single-blind, Randomized, Placebo-controlled, Pilot Clinical Trial
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.
Read the 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:
- Department of Critical Care Medicine of Zhujiang Hospital, Guangzhou, Guangdong, China Primary endpoint: 96-hour Sequential Organ Failure Assessment (SOFA) score Secondary endpoints:
- The state of inflammatory response: the serum level of interleukin-6(IL-6) and C-reactive protein (CRP) at 96 h after randomization.
- The state of liver function: the serum level of transaminase (AST#ALT) #total bilirubin at 96 h after randomization.
- The state of lung function: oxygenation index (PaO2/FiO2) at 96h after Randomization.
- The state of kidney function: the serum level of Creatinine (Cr)#blood urea nitrogen (BUN)# at 96 h after randomization.
- The state of infection: the serum level of procalcitonin (PCT) at 96 h after randomization.
- The state of circulation system: the serum level of lactate at 96 h after Randomization.
- The duration of successful cessation of supportive therapies for organ dysfunction including vasoactive agents, mechanical ventilation.
- The daily urine output#duration of continuous renal replacement therapy (CRRT) #fluid balance.
- The length of stay in ICU.
Safety endpoints:
- adverse events
- Serious adverse events
- Conditions
- Sepsis, Septic Shock
- Being tested
- apigenin, sterilized water
- Keywords
- sepsis, apigenin, septic shock
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apigeninOther
Intragastric tube injection of ground apigenin tablet 50 mg with 5 ml of sterilized water + conventional standardized treatment, for 4 consecutive days.
sterilized waterOther
Intragastric tube injection of 5 ml of sterilized water + conventional standardized treatment, for 4 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| apigenin | Experimental | Intragastric tube injection of ground apigenin tablet 50 mg with 5 ml of sterilized water + conventional standardized treatment, for 4 consecutive days. Receives: Other: apigenin |
| sterilized water | Placebo comparator | Gastric tube injection of 5 ml of sterilized water for injection + conventional standardized treatment, for 4 consecutive days. Receives: Other: sterilized water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
Secondary outcomes (16)
inflammatory response(1)
the serum level of C-reactive protein(CRP)
Measured: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
inflammatory response(2)
the serum level of interleukin-6(IL-6)
Measured: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
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)
Measured: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
liver function(1)
the serum level of Alanine transaminase(ALT)
Measured: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
liver function(2)
the serum level of Aspartate transaminase (AST)
Measured: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
liver function(3)
the serum level of total bilirubin(TBil)
Measured: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
lung function
oxygenation index(PaO2/FiO2),the patients treated with extracorporeal membrane oxygenation will not collect this indicator
Measured: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
kidney function(1)
serum level of Creatinine (Cr)
Measured: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
kidney function(2)
serum level of blood urea nitrogen(BUN)
Measured: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
Indicators of infection
the serum level of procalcitonin(PCT)
Measured: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
The level of lactate
the serum level of lactic acid
Measured: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
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)
Measured: The outcome will be assessed at the 28 day after enrollment
The duration of CRRT
The duration of CRRT therapy in hours
Measured: The outcome will be assessed at the 28 day after enrollment
Daily urine output
Daily urine output in milliliters from 0:00 - 24:00
Measured: The outcome will be assessed at the 1,2,3,4 day after enrollment
fluid balance
Net fluid intake and output in 24 hours
Measured: The outcome will be assessed at the 1,2,3,4 day after enrollment
The length of ICU stay
ICU length of ICU stay
Measured: The outcome will be assessed at the 28 day after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Sep 2023
- Primary completion5 Jan 2024
- Study completion5 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhanguo, Zhujiang Hospital
- Investigators
- Zhanguo Liu, M.D.PhD, Principal investigator, Department of Critical Care Medicine of Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999682
- Sponsor's protocol ID
- 2023-KY-085-03
- Status last verified
- Mar 2024
- First submitted
- 11 Aug 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets generated and analyzed during the study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Organ Function by Apigenin in Elderly Patients With Sepsis: A Single-center, Single-blind, Randomized, Placebo-controlled, Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT05999682
- Acronym / sponsor ID
- 2023-KY-085-03
- Conditions
- Sepsis, Septic Shock
- Keywords
- sepsis, apigenin, septic shock
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Department of Critical Care Medicine of Zhujiang Hospital, Guangzhou, Guangdong, China Primary endpoint: 96-hour Sequential Organ Failure Assessment (SOFA) score Secondary endpoints:
- The state of inflammatory response: the serum level of interleukin-6(IL-6) and C-reactive protein (CRP) at 96 h after randomization.
- The state of liver function: the serum level of transaminase (AST#ALT) #total bilirubin at 96 h after randomization.
- The state of lung function: oxygenation index (PaO2/FiO2) at 96h after Randomization.
- The state of kidney function: the serum level of Creatinine (Cr)#blood urea nitrogen (BUN)# at 96 h after randomization.
- The state of infection: the serum level of procalcitonin (PCT) at 96 h after randomization.
- The state of circulation system: the serum level of lactate at 96 h after Randomization.
- The duration of successful cessation of supportive therapies for organ dysfunction including vasoactive agents, mechanical ventilation.
- The daily urine output#duration of continuous renal replacement therapy (CRRT) #fluid balance.
- The length of stay in ICU.
Safety endpoints:
- adverse events
- Serious adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| apigenin | Experimental | Other: apigeninIntragastric tube injection of ground apigenin tablet 50 mg with 5 ml of sterilized water + conventional standardized treatment, for 4 consecutive days. |
| sterilized water | Placebo comparator | Other: sterilized waterGastric tube injection of 5 ml of sterilized water for injection + conventional standardized treatment, for 4 consecutive days. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- patients who are allergic to the study products;
- patients who are unable to feed via gastrointestinal nutrition tube.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| apigeninIntragastric tube injection of ground apigenin tablet 50 mg with 5 ml of sterilized water + conventional standardized treatment, for 4 consecutive days. | Other | apigenin |
| sterilized waterIntragastric tube injection of 5 ml of sterilized water + conventional standardized treatment, for 4 consecutive days. | Other | sterilized water |
Primary outcome
96-hour Sequential Organ Failure Assessment (SOFA) score
Time frame: 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.
16 secondary outcomes
inflammatory response(1)
Time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
inflammatory response(2)
Time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
Duration of use of vasoactive drugs
Time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
liver function(1)
Time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
liver function(2)
Time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
liver function(3)
Time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
lung function
Time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
kidney function(1)
Time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
kidney function(2)
Time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
Indicators of infection
Time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
The level of lactate
Time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
The Duration of use of mechanical ventilation (MV)
Time frame: The outcome will be assessed at the 28 day after enrollment
The duration of CRRT
Time frame: The outcome will be assessed at the 28 day after enrollment
Daily urine output
Time frame: The outcome will be assessed at the 1,2,3,4 day after enrollment
fluid balance
Time frame: The outcome will be assessed at the 1,2,3,4 day after enrollment
The length of ICU stay
Time frame: The outcome will be assessed at the 28 day after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: Undecided. The datasets generated and analyzed during the study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhanguo Liu, M.D.PhD principal investigator
Department of Critical Care Medicine of Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing apigenin and sterilized water in people with Sepsis and Septic Shock, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
96-hour Sequential Organ Failure Assessment (SOFA) score (time frame: The outcome will be assessed at the 0,1,2,3,4 day after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.