Septic ShockPhase 2/3NCT03749525
Shenfu Injection Improves Arterial Vascular Reactivity
A Phase 2/3 study testing shenfu injection in people with Septic Shock and Shenfu, run by Jianfeng Xie.
Trial summary
Septic shock is a common and critical illness in ICU.The vascular dysfunction of septic shock is manifested by vasospasm and decreased arterial vascular reactivity . Current studies have shown that the main mechanisms of vasospasm and decreased arterial vascular reactivity include increased vasospasm and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Septic Shock, Shenfu, Vascular Reactivity
- What is being tested?
- shenfu injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2018to Sep 2019
- Phase
- Phase 2/3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed as septic shock according to 2016 SSC Guidelines;
- The dose of norepinephrine required to maintain MAP>65mmHg ≥0.5μg/kg.min;
- SVRI <800 dyns/cm5.m2;
- CI>2.5L/min/m2;
- The patient or the patient's family signed the informed consent form for this trial.
Who cannot join
- septic shock occurs more than 24 hours;
- Age > 85 years old or <18 years old;
- pregnant or lactating women;
- There are shock patients caused by other causes such as cardiogenicity and neurogenicity;
- The terminal state of malignant tumor end-stage disease or the patient who is expected to die within 24 hours.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Shenfu Injection on Arterial Vascular Reactivity in Patients With Septic Shock
Septic shock is a common and critical illness in ICU.The vascular dysfunction of septic shock is manifested by vasospasm and decreased arterial vascular reactivity . Current studies have shown that the main mechanisms of vasospasm and decreased arterial vascular reactivity include increased vasospasm and down-regulation of receptor sensitivity , and eventually cause a decrease in vascular smooth muscle contractility.A large number of vasodilators are released during septic shock, in which inducible nitric oxide synthase (iNOS) and prostacyclin (PGI2) are important vasodilators leading to septic shock vasospasm.At present, vasoactive drugs are widely used in clinically to improve vascular tone and are important means of circulation support. However, when the infection is heavier, the reactivity of the blood vessels to the vasoactive drugs is lowered, and it is difficult for the large doses of the vasoactive drugs to maintain the circulation stability. At this time, the use of vasoactive drugs alone does not benefit patients with septic shock and may require the combination of other drugs.From the perspective of Chinese medicine, shock is a disease of yang. Shenfu injection has the effect of rejuvenating the yang and replenishing the qi. This trial was designed to give patients with septic shock the use of Shenfu injection to determine the specific effects of Shenfu injection on vascular reactivity in patients with septic shock.
- Conditions
- Septic Shock, Shenfu, Vascular Reactivity
- Being tested
- shenfu injection
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shenfu injectionDrug
Also called 5% GS solution
we hypothesis that shenfu injection could improve patients' arterial vascular reactivity with septic shock
| Study group | Role | What they receive |
|---|---|---|
| placebo group | Placebo comparator | 5% GS solution Receives: Drug: shenfu injection |
| control group | Active comparator | shenfu injection Receives: Drug: shenfu injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of peripheral vascular resistance
Peripheral vascular resistance will be measured by PiCCO or Swan-Ganz and the change between day 0 and day 3
Measured: day 0(before shenfu injection is used), day 3 (after shenfu injection is used for 72 hours)
Secondary outcomes (2)
Diastolic blood pressure
We will measure blood pressure every hour and diastolic blood pressure will be recorded per hour.
Measured: day 1, day 2, day 3
Dosage of vasoactive drugs
dosages of noradrenaline, adrenaline or any other kinds of vasoactive drugs
4/5000 dosages of adrenaline and norepinephrine
Measured: day 1, day 2,day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start1 Dec 2018 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianfeng Xie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianfeng Xie, Southeast University, China
- Investigators
- haibo qin, professor, Study chair, southeast university zhongda hospitial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749525
- Sponsor's protocol ID
- shenfu injection
- Status last verified
- Nov 2018
- First submitted
- 9 Jul 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shenfu Injection on Arterial Vascular Reactivity in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT03749525
- Acronym / sponsor ID
- shenfu injection
- Conditions
- Septic Shock, Shenfu, Vascular Reactivity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Jianfeng XieUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 21 Nov 2018 (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.
Septic shock is a common and critical illness in ICU.The vascular dysfunction of septic shock is manifested by vasospasm and decreased arterial vascular reactivity . Current studies have shown that the main mechanisms of vasospasm and decreased arterial vascular reactivity include increased vasospasm and down-regulation of receptor sensitivity , and eventually cause a decrease in vascular smooth muscle contractility.A large number of vasodilators are released during septic shock, in which inducible nitric oxide synthase (iNOS) and prostacyclin (PGI2) are important vasodilators leading to septic shock vasospasm.At present, vasoactive drugs are widely used in clinically to improve vascular tone and are important means of circulation support. However, when the infection is heavier, the reactivity of the blood vessels to the vasoactive drugs is lowered, and it is difficult for the large doses of the vasoactive drugs to maintain the circulation stability. At this time, the use of vasoactive drugs alone does not benefit patients with septic shock and may require the combination of other drugs.From the perspective of Chinese medicine, shock is a disease of yang. Shenfu injection has the effect of rejuvenating the yang and replenishing the qi. This trial was designed to give patients with septic shock the use of Shenfu injection to determine the specific effects of Shenfu injection on vascular reactivity in patients with septic shock.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | Drug: shenfu injection5% GS solution |
| control group | Active comparator | Drug: shenfu injectionshenfu injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosed as septic shock according to 2016 SSC Guidelines;
- The dose of norepinephrine required to maintain MAP>65mmHg ≥0.5μg/kg.min;
- SVRI <800 dyns/cm5.m2;
- CI>2.5L/min/m2;
- The patient or the patient's family signed the informed consent form for this trial.
Key exclusion criteria (5 listed)
- septic shock occurs more than 24 hours;
- Age > 85 years old or <18 years old;
- pregnant or lactating women;
- There are shock patients caused by other causes such as cardiogenicity and neurogenicity;
- The terminal state of malignant tumor end-stage disease or the patient who is expected to die within 24 hours.
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 |
|---|---|---|
| shenfu injectionAlso: 5% GS solutionwe hypothesis that shenfu injection could improve patients' arterial vascular reactivity with septic shock | Drug | control group, placebo group |
Primary outcome
The change of peripheral vascular resistance
Time frame: day 0(before shenfu injection is used), day 3 (after shenfu injection is used for 72 hours)
Peripheral vascular resistance will be measured by PiCCO or Swan-Ganz and the change between day 0 and day 3
2 secondary outcomes
Diastolic blood pressure
Time frame: day 1, day 2, day 3
Dosage of vasoactive drugs
Time frame: day 1, day 2,day 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
haibo qin, professor study chair
southeast university zhongda hospitial
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing shenfu injection in people with Septic Shock and Shenfu, run by Jianfeng Xie.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sun qin, doc (86-15952083606, sunqin1990@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of peripheral vascular resistance (time frame: day 0(before shenfu injection is used), day 3 (after shenfu injection is used for 72 hours)). 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 21 Nov 2018.