SepsisNCT06157320
Clinical Research on Shenfu Injection in Septic Patients
A study testing Shen-Fu and Norepinephrine (NE)，antibiotics，fluid resuscitation in people with Sepsis, run by Ruijin Hospital at 1 site in China.
Trial summary
Sepsis, characterized by organ dysfunction caused by infection, exhibits increasing incidence and mortality rates, posing a significant challenge to intensive care units. Early-stage sepsis involves hemodynamic disturbances, and severe and complex microcirculatory impairments can result in tissue hypoxia and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Shen-Fu and Norepinephrine (NE)，antibiotics，fluid resuscitation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 Jan 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Signed informed consent form;
- Meets sepsis 3.0 diagnostic criteria;
Who cannot join
- Age < 18 years;
- Known pregnancy;
- Inability to accept and complete signed informed consent within 24 hours of diagnosis of sepsis;
- Status of tracheal intubation;
- oral mucosal inflammation or damage;
- Patients with contraindications to transcutaneous oxygen partial pressure testing such as severe edema and burns;
- Concurrent participation in other treatment studies.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Jieming Qu, MD, +86 02164370045
About this study
Official title: Improving Microcirculation and Microvascular Leakage in Sepsis Patients: A Comprehensive Clinical Study of Shenfu Injection
Sepsis, characterized by organ dysfunction caused by infection, exhibits increasing incidence and mortality rates, posing a significant challenge to intensive care units. Early-stage sepsis involves hemodynamic disturbances, and severe and complex microcirculatory impairments can result in tissue hypoxia and accelerate organ dysfunction. Modern medical research has indicated that the effective and rapid restoration of microcirculatory function, along with the correction of microcirculatory disorders, is a crucial aspect in the treatment of sepsis. Current guidelines recommend the use of vasoactive drugs to address hemodynamic disturbances, but their administration may further damage the microcirculation. Additionally, in patients with severe sepsis, there often exists a disparity between macrocirculatory and microcirculatory hemodynamics, and conventional clinical indicators fail to directly reflect the level of microcirculatory perfusion.
Chinese guidelines have incorporated the use of traditional Chinese medicine (TCM) in the diagnosis and treatment of sepsis, offering a new therapeutic approach to ameliorate microcirculatory impairments. This study aims to include patients with sepsis and administer Shenfu Injection via intravenous therapy. Tongue microcirculation assessment will be employed to evaluate changes in microvascular health scores, while transcutaneous oxygen and carbon dioxide pressure alterations, as well as serum lactate level variations, will be monitored to ascertain the effects of Shenfu Injection on improving early-stage microcirculatory impairments and microvascular leakage in sepsis patients. This research will clarify the clinical efficacy of Shenfu Injection in sepsis patients with microcirculatory impairments, provide evidence-based medicine and clinical evidence for TCM treatment of sepsis, and offer a solid foundation for refining sepsis treatment strategies with distinct Chinese characteristics.
- Conditions
- Sepsis
- Being tested
- Shen-Fu, Norepinephrine (NE)，antibiotics，fluid resuscitation
- Keywords
- sepsis, microcirculation, Shenfu Injection
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shen-FuDrug
Also called Traditional Chinese medicine
Within 24 hours of sepsis diagnosis, patients received a daily intravenous infusion of 100 ml of Shenfu Injection for a continuous duration of 7 days.
Norepinephrine (NE)，antibiotics，fluid resuscitationDrug
Also called Strandard treatment
empirical antimicrobial treatment (which is promptly administered after microbial tests), fluid (crystalloids) replacement (to be established according to fluid tolerance and fluid responsiveness), and vasoactive agents (e.g., norepinephrine (NE)), which are employed to maintain mean arterial pressure above 65 mmHg and reduce the risk of fluid overload
| Study group | Role | What they receive |
|---|---|---|
| Shenfu Injection group | Experimental | within 24 hours after the diagnosis of sepsis, Shenfu injection 100 ml/day, intravenous use, continuous application for 7 days. Receives: Drug: Shen-Fu |
| Control group | Placebo comparator | sepsis was treated with standardized western medicine methods Receives: Drug: Norepinephrine (NE)，antibiotics，fluid resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
HR:heart rate
heart rate
Measured: Day0，Day1，Day 3，Day 7
BP:Blood pressure
Blood pressure
Measured: Day0，Day1，Day 3，Day 7
Proportion of perfused vessels
Grid-based score (3 horizontal and vertical equidistant lines). Percentage of perfused vessels per total number of vessel crossings
Measured: Day0，Day1，Day 3，Day 7
Microvascular fow index
fow, 1 = intermittent fow, 2 = sluggish fow, 3 = normal fow Semi-quantitative assessment of the average red blood cell velocity per quadrant
Measured: Day0，Day1，Day 3，Day 7
Heterogeneity index
Determinant of heterogeneity of blood fow, characteristic of distributive abnormalities
Measured: Day0，Day1，Day 3，Day 7
Hemodynamic parameters1
CI: Cardio index
Measured: Day0，Day1，Day 3，Day 7
Hemodynamic parameters2
SVRI:systemic vascular resistance index
Measured: Day0，Day1，Day 3，Day 7
Hemodynamic parameters3
GEDVI:global end-diastolic volume index
Measured: Day0，Day1，Day 3，Day 7
Secondary outcomes (26)
Ang2:Endothelial cell function indicators
Endothelial cell function indicators got from the blood of patients
Measured: Day0，Day1，Day 3，Day 7
VCAM1:Endothelial cell function indicators
Endothelial cell function indicators got from the blood of patients
Measured: Day0，Day1，Day 3，Day 7
Sydecan-1:Endothelial cell function indicators
Endothelial cell function indicators got from the blood of patients
Measured: Day0，Day1，Day 3，Day 7
6-Keto-PGF-1:Endothelial cell function indicators
Endothelial cell function indicators got from the blood of patients
Measured: Day0，Day1，Day 3，Day 7
TXB2:Endothelial cell function indicators
Endothelial cell function indicators got from the blood of patients
Measured: Day0，Day1，Day 3，Day 7
NO:Endothelial cell function indicators
Endothelial cell function indicators got from the blood of patients
Measured: Day0，Day1，Day 3，Day 7
Lab test1
PH
Measured: Day0，Day1，Day 3，Day 7
Lab test2
PaO2 mmHg,
Measured: Day0，Day1，Day 3，Day 7
Lab test3
PaCO2 mmHg
Measured: Day0，Day1，Day 3，Day 7
Lab test4
Serum lactate mmol/L
Measured: Day0，Day1，Day 3，Day 7
Lab test5
IL-10 ng/ml
Measured: Day0，Day1，Day 3，Day 7
Lab test6
WBC ×109/L
Measured: Day0，Day1，Day 3，Day 7
Lab test7
Neu ×109/L
Measured: Day0，Day1，Day 3，Day 7
Lab test8
Lym×109/L,
Measured: Day0，Day1，Day 3，Day 7
Lab test9
Hb g/L,
Measured: Day0，Day1，Day 3，Day 7
Lab test10
PLT×109/L
Measured: Day0，Day1，Day 3，Day 7
Lab test11
Total bilirubin IU/L
Measured: Day0，Day1，Day 3，Day 7
Lab test12
Cr μmol/L
Measured: Day0，Day1，Day 3，Day 7
Lab test13
IL-1βng/ml
Measured: Day0，Day1，Day 3，Day 7
Lab test14
APTT s
Measured: Day0，Day1，Day 3，Day 7
Lab test15
D-Dimermg/L
Measured: Day0，Day1，Day 3，Day 7
Lab test16
CRP mg/L
Measured: Day0，Day1，Day 3，Day 7
Lab test17
ProBNP pg/ml
Measured: Day0，Day1，Day 3，Day 7
Lab test18
PCT ng/ml
Measured: Day0，Day1，Day 3，Day 7
Lab test19
TNFαng/ml
Measured: Day0，Day1，Day 3，Day 7
Lab test20
IL-6 ng/ml
Measured: Day0，Day1，Day 3，Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Ruijin 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wu Jieping Medical Foundation
- Responsible party
- Sponsor
- Investigators
- Hongping Qu, Study director, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157320
- Sponsor's protocol ID
- 320.6750.2022-2-35
- Status last verified
- Jan 2023
- First submitted
- 19 Jul 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338Gutterman DD, Chabowski DS, Kadlec AO, Durand MJ, Freed JK, Ait-Aissa K, Beyer AM. The Human Microcirculation: Regulation of Flow and Beyond. Circ Res. 2016 Jan 8;118(1):157-72. doi: 10.1161/CIRCRESAHA.115.305364.
PubMed 26837746Tian R, Wang X, Pan T, Li R, Wang J, Liu Z, Chen E, Mao E, Tan R, Chen Y, Liu J, Qu H. Plasma PTX3, MCP1 and Ang2 are early biomarkers to evaluate the severity of sepsis and septic shock. Scand J Immunol. 2019 Dec;90(6):e12823. doi: 10.1111/sji.12823. Epub 2019 Oct 7.
PubMed 31489646Tian R, Li R, Liu Y, Liu J, Pan T, Zhang R, Liu B, Chen E, Tang Y, Qu H. Metformin ameliorates endotoxemia-induced endothelial pro-inflammatory responses via AMPK-dependent mediation of HDAC5 and KLF2. Biochim Biophys Acta Mol Basis Dis. 2019 Jun 1;1865(6):1701-1712. doi: 10.1016/j.bbadis.2019.04.009. Epub 2019 Apr 16.
PubMed 31002870Yao B, Liu DW, Chai WZ, Wang XT, Zhang HM. Microcirculation dysfunction in endotoxic shock rabbits is associated with impaired S-nitrosohemoglobin-mediated nitric oxide release from red blood cells: a preliminary study. Intensive Care Med Exp. 2019 Jan 7;7(1):1. doi: 10.1186/s40635-018-0215-0.
PubMed 30617929Otero RM, Nguyen HB, Huang DT, Gaieski DF, Goyal M, Gunnerson KJ, Trzeciak S, Sherwin R, Holthaus CV, Osborn T, Rivers EP. Early goal-directed therapy in severe sepsis and septic shock revisited: concepts, controversies, and contemporary findings. Chest. 2006 Nov;130(5):1579-95. doi: 10.1378/chest.130.5.1579.
PubMed 17099041Fan KL, Wang JH, Kong L, Zhang FH, Hao H, Zhao H, Tian ZY, Yin MX, Fang H, Yang HH, Liu Y. Effect of Shen-Fu Injection () on Hemodynamics in Early Volume Resuscitation Treated Septic Shock Patients. Chin J Integr Med. 2019 Jan;25(1):59-63. doi: 10.1007/s11655-017-2965-z. Epub 2017 Oct 6.
PubMed 28986814Zhang XJ, Song L, Zhou ZG, Wang XM. Effect of shenfu injection on gastrointestinal microcirculation in rabbits after myocardial ischemia-reperfusion injury. World J Gastroenterol. 2006 Jul 21;12(27):4389-91. doi: 10.3748/wjg.v12.i27.4389.
PubMed 16865783Zhang X, Guo T, Zhang K, Guo W, An X, Gao P. Effect of shenfu injection on microcirculation in shock patients: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2020 Oct 23;99(43):e22872. doi: 10.1097/MD.0000000000022872.
PubMed 33120828Ince C. Hemodynamic coherence and the rationale for monitoring the microcirculation. Crit Care. 2015;19 Suppl 3(Suppl 3):S8. doi: 10.1186/cc14726. Epub 2015 Dec 18.
PubMed 26729241
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Microcirculation and Microvascular Leakage in Sepsis Patients: A Comprehensive Clinical Study of Shenfu Injection
- ClinicalTrials.gov ID
- NCT06157320
- Acronym / sponsor ID
- 320.6750.2022-2-35
- Conditions
- Sepsis
- Keywords
- sepsis, microcirculation, Shenfu Injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Wu Jieping Medical Foundation
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 5 Dec 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.
Sepsis, characterized by organ dysfunction caused by infection, exhibits increasing incidence and mortality rates, posing a significant challenge to intensive care units. Early-stage sepsis involves hemodynamic disturbances, and severe and complex microcirculatory impairments can result in tissue hypoxia and accelerate organ dysfunction. Modern medical research has indicated that the effective and rapid restoration of microcirculatory function, along with the correction of microcirculatory disorders, is a crucial aspect in the treatment of sepsis. Current guidelines recommend the use of vasoactive drugs to address hemodynamic disturbances, but their administration may further damage the microcirculation. Additionally, in patients with severe sepsis, there often exists a disparity between macrocirculatory and microcirculatory hemodynamics, and conventional clinical indicators fail to directly reflect the level of microcirculatory perfusion.
Chinese guidelines have incorporated the use of traditional Chinese medicine (TCM) in the diagnosis and treatment of sepsis, offering a new therapeutic approach to ameliorate microcirculatory impairments. This study aims to include patients with sepsis and administer Shenfu Injection via intravenous therapy. Tongue microcirculation assessment will be employed to evaluate changes in microvascular health scores, while transcutaneous oxygen and carbon dioxide pressure alterations, as well as serum lactate level variations, will be monitored to ascertain the effects of Shenfu Injection on improving early-stage microcirculatory impairments and microvascular leakage in sepsis patients. This research will clarify the clinical efficacy of Shenfu Injection in sepsis patients with microcirculatory impairments, provide evidence-based medicine and clinical evidence for TCM treatment of sepsis, and offer a solid foundation for refining sepsis treatment strategies with distinct Chinese characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shenfu Injection group | Experimental | Drug: Shen-Fuwithin 24 hours after the diagnosis of sepsis, Shenfu injection 100 ml/day, intravenous use, continuous application for 7 days. |
| Control group | Placebo comparator | Drug: Norepinephrine (NE)，antibiotics，fluid resuscitationsepsis was treated with standardized western medicine methods |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Signed informed consent form;
- Meets sepsis 3.0 diagnostic criteria;
Key exclusion criteria (7 listed)
- Age < 18 years;
- Known pregnancy;
- Inability to accept and complete signed informed consent within 24 hours of diagnosis of sepsis;
- Status of tracheal intubation;
- oral mucosal inflammation or damage;
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 |
|---|---|---|
| Shen-FuAlso: Traditional Chinese medicineWithin 24 hours of sepsis diagnosis, patients received a daily intravenous infusion of 100 ml of Shenfu Injection for a continuous duration of 7 days. | Drug | Shenfu Injection group |
| Norepinephrine (NE)，antibiotics，fluid resuscitationAlso: Strandard treatmentempirical antimicrobial treatment (which is promptly administered after microbial tests), fluid (crystalloids) replacement (to be established according to fluid tolerance and fluid responsiveness), and vasoactive agents (e.g., norepinephrine (NE)), which are employed to maintain mean arterial pressure above 65 mmHg and reduce the risk of fluid overload | Drug | Control group |
Primary outcome
HR:heart rate
Time frame: Day0，Day1，Day 3，Day 7
heart rate
BP:Blood pressure
Time frame: Day0，Day1，Day 3，Day 7
Blood pressure
Proportion of perfused vessels
Time frame: Day0，Day1，Day 3，Day 7
Grid-based score (3 horizontal and vertical equidistant lines). Percentage of perfused vessels per total number of vessel crossings
Microvascular fow index
Time frame: Day0，Day1，Day 3，Day 7
fow, 1 = intermittent fow, 2 = sluggish fow, 3 = normal fow Semi-quantitative assessment of the average red blood cell velocity per quadrant
Heterogeneity index
Time frame: Day0，Day1，Day 3，Day 7
Determinant of heterogeneity of blood fow, characteristic of distributive abnormalities
Hemodynamic parameters1
Time frame: Day0，Day1，Day 3，Day 7
CI: Cardio index
Hemodynamic parameters2
Time frame: Day0，Day1，Day 3，Day 7
SVRI:systemic vascular resistance index
Hemodynamic parameters3
Time frame: Day0，Day1，Day 3，Day 7
GEDVI:global end-diastolic volume index
26 secondary outcomes
Ang2:Endothelial cell function indicators
Time frame: Day0，Day1，Day 3，Day 7
VCAM1:Endothelial cell function indicators
Time frame: Day0，Day1，Day 3，Day 7
Sydecan-1:Endothelial cell function indicators
Time frame: Day0，Day1，Day 3，Day 7
6-Keto-PGF-1:Endothelial cell function indicators
Time frame: Day0，Day1，Day 3，Day 7
TXB2:Endothelial cell function indicators
Time frame: Day0，Day1，Day 3，Day 7
NO:Endothelial cell function indicators
Time frame: Day0，Day1，Day 3，Day 7
Lab test1
Time frame: Day0，Day1，Day 3，Day 7
Lab test2
Time frame: Day0，Day1，Day 3，Day 7
Lab test3
Time frame: Day0，Day1，Day 3，Day 7
Lab test4
Time frame: Day0，Day1，Day 3，Day 7
Lab test5
Time frame: Day0，Day1，Day 3，Day 7
Lab test6
Time frame: Day0，Day1，Day 3，Day 7
Lab test7
Time frame: Day0，Day1，Day 3，Day 7
Lab test8
Time frame: Day0，Day1，Day 3，Day 7
Lab test9
Time frame: Day0，Day1，Day 3，Day 7
Lab test10
Time frame: Day0，Day1，Day 3，Day 7
Lab test11
Time frame: Day0，Day1，Day 3，Day 7
Lab test12
Time frame: Day0，Day1，Day 3，Day 7
Lab test13
Time frame: Day0，Day1，Day 3，Day 7
Lab test14
Time frame: Day0，Day1，Day 3，Day 7
Lab test15
Time frame: Day0，Day1，Day 3，Day 7
Lab test16
Time frame: Day0，Day1，Day 3，Day 7
Lab test17
Time frame: Day0，Day1，Day 3，Day 7
Lab test18
Time frame: Day0，Day1，Day 3，Day 7
Lab test19
Time frame: Day0，Day1，Day 3，Day 7
Lab test20
Time frame: Day0，Day1，Day 3，Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
- Results publication: PubMed 26837746Gutterman DD, Chabowski DS, Kadlec AO, Durand MJ, Freed JK, Ait-Aissa K, Beyer AM. The Human Microcirculation: Regulation of Flow and Beyond. Circ Res. 2016 Jan 8;118(1):157-72. doi: 10.1161/CIRCRESAHA.115.305364.
- Results publication: PubMed 31489646Tian R, Wang X, Pan T, Li R, Wang J, Liu Z, Chen E, Mao E, Tan R, Chen Y, Liu J, Qu H. Plasma PTX3, MCP1 and Ang2 are early biomarkers to evaluate the severity of sepsis and septic shock. Scand J Immunol. 2019 Dec;90(6):e12823. doi: 10.1111/sji.12823. Epub 2019 Oct 7.
- Results publication: PubMed 31002870Tian R, Li R, Liu Y, Liu J, Pan T, Zhang R, Liu B, Chen E, Tang Y, Qu H. Metformin ameliorates endotoxemia-induced endothelial pro-inflammatory responses via AMPK-dependent mediation of HDAC5 and KLF2. Biochim Biophys Acta Mol Basis Dis. 2019 Jun 1;1865(6):1701-1712. doi: 10.1016/j.bbadis.2019.04.009. Epub 2019 Apr 16.
- Results publication: PubMed 30617929Yao B, Liu DW, Chai WZ, Wang XT, Zhang HM. Microcirculation dysfunction in endotoxic shock rabbits is associated with impaired S-nitrosohemoglobin-mediated nitric oxide release from red blood cells: a preliminary study. Intensive Care Med Exp. 2019 Jan 7;7(1):1. doi: 10.1186/s40635-018-0215-0.
- Results publication: PubMed 17099041Otero RM, Nguyen HB, Huang DT, Gaieski DF, Goyal M, Gunnerson KJ, Trzeciak S, Sherwin R, Holthaus CV, Osborn T, Rivers EP. Early goal-directed therapy in severe sepsis and septic shock revisited: concepts, controversies, and contemporary findings. Chest. 2006 Nov;130(5):1579-95. doi: 10.1378/chest.130.5.1579.
- Results publication: PubMed 28986814Fan KL, Wang JH, Kong L, Zhang FH, Hao H, Zhao H, Tian ZY, Yin MX, Fang H, Yang HH, Liu Y. Effect of Shen-Fu Injection () on Hemodynamics in Early Volume Resuscitation Treated Septic Shock Patients. Chin J Integr Med. 2019 Jan;25(1):59-63. doi: 10.1007/s11655-017-2965-z. Epub 2017 Oct 6.
- Results publication: PubMed 16865783Zhang XJ, Song L, Zhou ZG, Wang XM. Effect of shenfu injection on gastrointestinal microcirculation in rabbits after myocardial ischemia-reperfusion injury. World J Gastroenterol. 2006 Jul 21;12(27):4389-91. doi: 10.3748/wjg.v12.i27.4389.
- Results publication: PubMed 33120828Zhang X, Guo T, Zhang K, Guo W, An X, Gao P. Effect of shenfu injection on microcirculation in shock patients: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2020 Oct 23;99(43):e22872. doi: 10.1097/MD.0000000000022872.
- Results publication: PubMed 26729241Ince C. Hemodynamic coherence and the rationale for monitoring the microcirculation. Crit Care. 2015;19 Suppl 3(Suppl 3):S8. doi: 10.1186/cc14726. Epub 2015 Dec 18.
- Individual participant dataSharing planned: No
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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.
Hongping Qu study director
Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shen-Fu and Norepinephrine (NE)，antibiotics，fluid resuscitation in people with Sepsis, run by Ruijin 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 7 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 5 Dec 2023. 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.
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 Hongping Qu, phD，MD (+86 13641801889, hongpingqu0412@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HR:heart rate (time frame: Day0，Day1，Day 3，Day 7). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06157320, which also lists 10 linked publications.
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 5 Dec 2023.