SepsisPhase 4DEX-SNS-SEPSISNCT07470775
Early Dexmedetomidine and Sympathetic Regulation in Sepsis
A Phase 4 study testing Dexmedetomidine (DEX) in people with Sepsis and Septic Shock, run by Sichuan Academy of Medical Sciences.
Trial summary
The goal of this clinical trial is to learn whether early administration of dexmedetomidine can improve autonomic nervous system regulation and clinical outcomes in adult patients with septic shock. It will also evaluate the safety of dexmedetomidine in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- Dexmedetomidine (DEX)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 year Septic shock defined by Sepsis-3 criteria Enrollment within 24 hours of diagnosis APACHE II score > 10
Who cannot join
- Pregnancy or lactation Second- or third-degree atrioventricular block Persistent bradycardia (HR <50 bpm) requiring intervention Hypersensitivity to dexmedetomidine Norepinephrine dose >0.5 μg/kg/min End-stage disease or life expectancy <72 hours Any condition deemed unsuitable by the investigator
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Study on the Effects of Early Dexmedetomidine Administration on Sympathetic Nervous System Activity, Pathophysiological Mechanisms, and Clinical Outcomes in Sepsis
The goal of this clinical trial is to learn whether early administration of dexmedetomidine can improve autonomic nervous system regulation and clinical outcomes in adult patients with septic shock. It will also evaluate the safety of dexmedetomidine in this population.
The main questions it aims to answer are:
Read more
Does early dexmedetomidine improve sympathetic nervous system activity, as measured by heart rate variability (HRV) and blood pressure variability (BPV)?
Does dexmedetomidine reduce endogenous catecholamine levels and vasopressor requirements?
Does early autonomic modulation improve organ function and survival outcomes in septic shock? Researchers will compare dexmedetomidine to a placebo (normal saline) to determine whether dexmedetomidine improves hemodynamic stability and prognosis in patients with septic shock.
Participants will:
Be randomly assigned to receive dexmedetomidine (0.5 μg/kg/h) or placebo by continuous intravenous infusion for 48 hours
Undergo continuous ECG and invasive blood pressure monitoring
Have blood samples collected at predefined time points to measure inflammatory markers and endogenous catecholamine levels
Be assessed for organ function, vasopressor use, and perfusion parameters during the first 48 hours
Be followed up for 28-day and 90-day survival outcomes
- Conditions
- Sepsis, Septic Shock
- Being tested
- Dexmedetomidine (DEX), Placebo
- Keywords
- Dexmedetomidine, Sympathetic Nervous System, 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.
Dexmedetomidine (DEX)Drug
0.5 micrograms per kilogram per hour (0.5 μg/kg/h)
PlaceboDrug
0.9% Sodium Chloride Injection
| Study group | Role | What they receive |
|---|---|---|
| ARM1 | Placebo comparator | Not described Receives: Drug: Placebo |
| Dexmedetomidine | Active comparator | Not described Receives: Drug: Dexmedetomidine (DEX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability (HRV)
Heart rate variability will be assessed using continuous electrocardiographic monitoring. The primary HRV parameter analyzed will be the standard deviation of normal-to-normal intervals (SDNN).
Measured: From enrollment to the end of treatment at 48 hours
Secondary outcomes (10)
Change in Sequential Organ Failure Assessment (SOFA) Score
The change in Sequential Organ Failure Assessment (SOFA) score from baseline to 48 hours will be used to evaluate organ dysfunction.
Measured: From enrollment to the end of treatment at 48 hours
Interleukin-6 (IL-6) level
Change in plasma IL-6 levels from baseline to 48 hours
Measured: From enrollment to the end of treatment at 48 hours
ICU length of stay
Duration of ICU stay for each participant
Measured: From enrollment to ICU discharge or 90 days, whichever occurs first
Duration of Mechanical Ventilation
Total duration of invasive mechanical ventilation during the first 48 hours after enrollment.
Measured: From randomization until successful liberation from mechanical ventilation, assessed up to 28 days.
Requirement for Renal Replacement Therapy (RRT)
Number of participants requiring renal replacement therapy during the first 48 hours after enrollment.
Measured: From randomization to 28 days after randomization.
Tumor necrosis factor-α (TNF-α) level
Change in plasma TNF-α levels from baseline to 48 hours
Measured: From enrollment to the end of treatment at 48 hours
Procalcitonin (PCT) clearance
Percentage change in PCT levels relative to baseline
Measured: From enrollment to the end of treatment at 48 hours
28-day all-cause mortality
Proportion of participants who die from any cause within 28 days of enrollment
Measured: From enrollment to 28 days
90-day all-cause mortality
Proportion of participants who die from any cause within 90 days of enrollment
Measured: From enrollment to 90 days
Incidence of new-onset organ dysfunction
Number of participants developing new organ dysfunction during the study period
Measured: From enrollment to 90 days or ICU/hospital discharge, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rongan Liu, Sichuan Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470775
- Sponsor's protocol ID
- IRB No. 927-1 (2025)
- Acronym
- DEX-SNS-SEPSIS
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim D, Park Y, Choi KH, Park TK, Lee JM, Cho YH, Choi JO, Jeon ES, Yang JH. Prognostic Implication of RV Coupling to Pulmonary Circulation for Successful Weaning From Extracorporeal Membrane Oxygenation. JACC Cardiovasc Imaging. 2021 Aug;14(8):1523-1531. doi: 10.1016/j.jcmg.2021.02.018. Epub 2021 Apr 14.
PubMed 33865793Carrara M, Ferrario M, Bollen Pinto B, Herpain A. The autonomic nervous system in septic shock and its role as a future therapeutic target: a narrative review. Ann Intensive Care. 2021 May 17;11(1):80. doi: 10.1186/s13613-021-00869-7.
PubMed 33999297Haenecour AS, Seto W, Urbain CM, Stephens D, Laussen PC, Balit CR. Prolonged Dexmedetomidine Infusion and Drug Withdrawal In Critically Ill Children. J Pediatr Pharmacol Ther. 2017 Nov-Dec;22(6):453-460. doi: 10.5863/1551-6776-22.6.453.
PubMed 29290746Tobias JD. Dexmedetomidine: Are There Going to be Issues with Prolonged Administration? J Pediatr Pharmacol Ther. 2010 Jan;15(1):4-9. No abstract available.
PubMed 22477787Ammar MA, Sacha GL, Welch SC, Bass SN, Kane-Gill SL, Duggal A, Ammar AA. Sedation, Analgesia, and Paralysis in COVID-19 Patients in the Setting of Drug Shortages. J Intensive Care Med. 2021 Feb;36(2):157-174. doi: 10.1177/0885066620951426. Epub 2020 Aug 26.
PubMed 32844730Dargent A, Bourredjem A, Jacquier M, Bohe J, Argaud L, Levy B, Fournel I, Cransac A, Badie J, Quintin L, Quenot JP. Dexmedetomidine to Reduce Vasopressor Resistance in Refractory Septic Shock: alpha2 Agonist Dexmedetomidine for REfractory Septic Shock (ADRESS): A Double-Blind Randomized Controlled Pilot Trial. Crit Care Med. 2025 Apr 1;53(4):e884-e896. doi: 10.1097/CCM.0000000000006608. Epub 2025 Feb 28.
PubMed 40019329Shehabi Y, Howe BD, Bellomo R, Arabi YM, Bailey M, Bass FE, Bin Kadiman S, McArthur CJ, Murray L, Reade MC, Seppelt IM, Takala J, Wise MP, Webb SA; ANZICS Clinical Trials Group and the SPICE III Investigators. Early Sedation with Dexmedetomidine in Critically Ill Patients. N Engl J Med. 2019 Jun 27;380(26):2506-2517. doi: 10.1056/NEJMoa1904710. Epub 2019 May 19.
PubMed 31112380Grayson KE, Bailey M, Balachandran M, Banneheke PP, Belletti A, Bellomo R, Naorungroj T, Serpa-Neto A, Wright JD, Yanase F, Young PJ, Shehabi Y. The Effect of Early Sedation With Dexmedetomidine on Body Temperature in Critically Ill Patients. Crit Care Med. 2021 Jul 1;49(7):1118-1128. doi: 10.1097/CCM.0000000000004935.
PubMed 33729724Kurnik D, Friedman EA, Muszkat M, Sofowora GG, Xie HG, Dupont WD, Wood AJ, Stein CM. Genetic variants in the alpha2C-adrenoceptor and G-protein contribute to ethnic differences in cardiovascular stress responses. Pharmacogenet Genomics. 2008 Sep;18(9):743-50. doi: 10.1097/FPC.0b013e3282fee5a1.
PubMed 18698227Morelli A, Sanfilippo F, Arnemann P, Hessler M, Kampmeier TG, D'Egidio A, Orecchioni A, Santonocito C, Frati G, Greco E, Westphal M, Rehberg SW, Ertmer C. The Effect of Propofol and Dexmedetomidine Sedation on Norepinephrine Requirements in Septic Shock Patients: A Crossover Trial. Crit Care Med. 2019 Feb;47(2):e89-e95. doi: 10.1097/CCM.0000000000003520.
PubMed 30394918Dardalas I, Stamoula E, Rigopoulos P, Malliou F, Tsaousi G, Aidoni Z, Grosomanidis V, Milonas A, Papazisis G, Kouvelas D, Pourzitaki C. Dexmedetomidine effects in different experimental sepsis in vivo models. Eur J Pharmacol. 2019 Aug 5;856:172401. doi: 10.1016/j.ejphar.2019.05.030. Epub 2019 May 17.
PubMed 31108055Taniguchi T, Kidani Y, Kanakura H, Takemoto Y, Yamamoto K. Effects of dexmedetomidine on mortality rate and inflammatory responses to endotoxin-induced shock in rats. Crit Care Med. 2004 Jun;32(6):1322-6. doi: 10.1097/01.ccm.0000128579.84228.2a.
PubMed 15187514Geloen A, Chapelier K, Cividjian A, Dantony E, Rabilloud M, May CN, Quintin L. Clonidine and dexmedetomidine increase the pressor response to norepinephrine in experimental sepsis: a pilot study. Crit Care Med. 2013 Dec;41(12):e431-8. doi: 10.1097/CCM.0b013e3182986248.
PubMed 23963131Ostrowski SR, Gaini S, Pedersen C, Johansson PI. Sympathoadrenal activation and endothelial damage in patients with varying degrees of acute infectious disease: an observational study. J Crit Care. 2015 Feb;30(1):90-6. doi: 10.1016/j.jcrc.2014.10.006. Epub 2014 Oct 8.
PubMed 25457118Stolk RF, van der Pasch E, Naumann F, Schouwstra J, Bressers S, van Herwaarden AE, Gerretsen J, Schambergen R, Ruth MM, van der Hoeven JG, van Leeuwen H, Pickkers P, Kox M. Norepinephrine Dysregulates the Immune Response and Compromises Host Defense during Sepsis. Am J Respir Crit Care Med. 2020 Sep 15;202(6):830-842. doi: 10.1164/rccm.202002-0339OC.
PubMed 32520577
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Effects of Early Dexmedetomidine Administration on Sympathetic Nervous System Activity, Pathophysiological Mechanisms, and Clinical Outcomes in Sepsis
- ClinicalTrials.gov ID
- NCT07470775
- Acronym / sponsor ID
- DEX-SNS-SEPSIS / IRB No. 927-1 (2025)
- Conditions
- Sepsis, Septic Shock
- Keywords
- Dexmedetomidine, Sympathetic Nervous System, Septic Shock
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Sichuan Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 13 Mar 2026 (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.
The goal of this clinical trial is to learn whether early administration of dexmedetomidine can improve autonomic nervous system regulation and clinical outcomes in adult patients with septic shock. It will also evaluate the safety of dexmedetomidine in this population.
The main questions it aims to answer are:
Does early dexmedetomidine improve sympathetic nervous system activity, as measured by heart rate variability (HRV) and blood pressure variability (BPV)?
Does dexmedetomidine reduce endogenous catecholamine levels and vasopressor requirements?
Does early autonomic modulation improve organ function and survival outcomes in septic shock? Researchers will compare dexmedetomidine to a placebo (normal saline) to determine whether dexmedetomidine improves hemodynamic stability and prognosis in patients with septic shock.
Participants will:
Be randomly assigned to receive dexmedetomidine (0.5 μg/kg/h) or placebo by continuous intravenous infusion for 48 hours
Undergo continuous ECG and invasive blood pressure monitoring
Have blood samples collected at predefined time points to measure inflammatory markers and endogenous catecholamine levels
Be assessed for organ function, vasopressor use, and perfusion parameters during the first 48 hours
Be followed up for 28-day and 90-day survival outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM1 | Placebo comparator | Drug: Placebo |
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine (DEX) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥ 18 year Septic shock defined by Sepsis-3 criteria Enrollment within 24 hours of diagnosis APACHE II score > 10
Key exclusion criteria (1 listed)
- Pregnancy or lactation Second- or third-degree atrioventricular block Persistent bradycardia (HR <50 bpm) requiring intervention Hypersensitivity to dexmedetomidine Norepinephrine dose >0.5 μg/kg/min End-stage disease or life expectancy <72 hours Any condition deemed unsuitable by the investigator
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 |
|---|---|---|
| Dexmedetomidine (DEX)0.5 micrograms per kilogram per hour (0.5 μg/kg/h) | Drug | Dexmedetomidine |
| Placebo0.9% Sodium Chloride Injection | Drug | ARM1 |
Primary outcome
Heart Rate Variability (HRV)
Time frame: From enrollment to the end of treatment at 48 hours
Heart rate variability will be assessed using continuous electrocardiographic monitoring. The primary HRV parameter analyzed will be the standard deviation of normal-to-normal intervals (SDNN).
10 secondary outcomes
Change in Sequential Organ Failure Assessment (SOFA) Score
Time frame: From enrollment to the end of treatment at 48 hours
Interleukin-6 (IL-6) level
Time frame: From enrollment to the end of treatment at 48 hours
ICU length of stay
Time frame: From enrollment to ICU discharge or 90 days, whichever occurs first
Duration of Mechanical Ventilation
Time frame: From randomization until successful liberation from mechanical ventilation, assessed up to 28 days.
Requirement for Renal Replacement Therapy (RRT)
Time frame: From randomization to 28 days after randomization.
Tumor necrosis factor-α (TNF-α) level
Time frame: From enrollment to the end of treatment at 48 hours
Procalcitonin (PCT) clearance
Time frame: From enrollment to the end of treatment at 48 hours
28-day all-cause mortality
Time frame: From enrollment to 28 days
90-day all-cause mortality
Time frame: From enrollment to 90 days
Incidence of new-onset organ dysfunction
Time frame: From enrollment to 90 days or ICU/hospital discharge, whichever occurs first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Results publication: PubMed 33865793Kim D, Park Y, Choi KH, Park TK, Lee JM, Cho YH, Choi JO, Jeon ES, Yang JH. Prognostic Implication of RV Coupling to Pulmonary Circulation for Successful Weaning From Extracorporeal Membrane Oxygenation. JACC Cardiovasc Imaging. 2021 Aug;14(8):1523-1531. doi: 10.1016/j.jcmg.2021.02.018. Epub 2021 Apr 14.
- Results publication: PubMed 33999297Carrara M, Ferrario M, Bollen Pinto B, Herpain A. The autonomic nervous system in septic shock and its role as a future therapeutic target: a narrative review. Ann Intensive Care. 2021 May 17;11(1):80. doi: 10.1186/s13613-021-00869-7.
- Results publication: PubMed 29290746Haenecour AS, Seto W, Urbain CM, Stephens D, Laussen PC, Balit CR. Prolonged Dexmedetomidine Infusion and Drug Withdrawal In Critically Ill Children. J Pediatr Pharmacol Ther. 2017 Nov-Dec;22(6):453-460. doi: 10.5863/1551-6776-22.6.453.
- Results publication: PubMed 22477787Tobias JD. Dexmedetomidine: Are There Going to be Issues with Prolonged Administration? J Pediatr Pharmacol Ther. 2010 Jan;15(1):4-9. No abstract available.
- Results publication: PubMed 32844730Ammar MA, Sacha GL, Welch SC, Bass SN, Kane-Gill SL, Duggal A, Ammar AA. Sedation, Analgesia, and Paralysis in COVID-19 Patients in the Setting of Drug Shortages. J Intensive Care Med. 2021 Feb;36(2):157-174. doi: 10.1177/0885066620951426. Epub 2020 Aug 26.
- Results publication: PubMed 40019329Dargent A, Bourredjem A, Jacquier M, Bohe J, Argaud L, Levy B, Fournel I, Cransac A, Badie J, Quintin L, Quenot JP. Dexmedetomidine to Reduce Vasopressor Resistance in Refractory Septic Shock: alpha2 Agonist Dexmedetomidine for REfractory Septic Shock (ADRESS): A Double-Blind Randomized Controlled Pilot Trial. Crit Care Med. 2025 Apr 1;53(4):e884-e896. doi: 10.1097/CCM.0000000000006608. Epub 2025 Feb 28.
- Results publication: PubMed 31112380Shehabi Y, Howe BD, Bellomo R, Arabi YM, Bailey M, Bass FE, Bin Kadiman S, McArthur CJ, Murray L, Reade MC, Seppelt IM, Takala J, Wise MP, Webb SA; ANZICS Clinical Trials Group and the SPICE III Investigators. Early Sedation with Dexmedetomidine in Critically Ill Patients. N Engl J Med. 2019 Jun 27;380(26):2506-2517. doi: 10.1056/NEJMoa1904710. Epub 2019 May 19.
- Results publication: PubMed 33729724Grayson KE, Bailey M, Balachandran M, Banneheke PP, Belletti A, Bellomo R, Naorungroj T, Serpa-Neto A, Wright JD, Yanase F, Young PJ, Shehabi Y. The Effect of Early Sedation With Dexmedetomidine on Body Temperature in Critically Ill Patients. Crit Care Med. 2021 Jul 1;49(7):1118-1128. doi: 10.1097/CCM.0000000000004935.
- Results publication: PubMed 18698227Kurnik D, Friedman EA, Muszkat M, Sofowora GG, Xie HG, Dupont WD, Wood AJ, Stein CM. Genetic variants in the alpha2C-adrenoceptor and G-protein contribute to ethnic differences in cardiovascular stress responses. Pharmacogenet Genomics. 2008 Sep;18(9):743-50. doi: 10.1097/FPC.0b013e3282fee5a1.
- Results publication: PubMed 30394918Morelli A, Sanfilippo F, Arnemann P, Hessler M, Kampmeier TG, D'Egidio A, Orecchioni A, Santonocito C, Frati G, Greco E, Westphal M, Rehberg SW, Ertmer C. The Effect of Propofol and Dexmedetomidine Sedation on Norepinephrine Requirements in Septic Shock Patients: A Crossover Trial. Crit Care Med. 2019 Feb;47(2):e89-e95. doi: 10.1097/CCM.0000000000003520.
- Results publication: PubMed 31108055Dardalas I, Stamoula E, Rigopoulos P, Malliou F, Tsaousi G, Aidoni Z, Grosomanidis V, Milonas A, Papazisis G, Kouvelas D, Pourzitaki C. Dexmedetomidine effects in different experimental sepsis in vivo models. Eur J Pharmacol. 2019 Aug 5;856:172401. doi: 10.1016/j.ejphar.2019.05.030. Epub 2019 May 17.
- Results publication: PubMed 15187514Taniguchi T, Kidani Y, Kanakura H, Takemoto Y, Yamamoto K. Effects of dexmedetomidine on mortality rate and inflammatory responses to endotoxin-induced shock in rats. Crit Care Med. 2004 Jun;32(6):1322-6. doi: 10.1097/01.ccm.0000128579.84228.2a.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine (DEX) in people with Sepsis and Septic Shock, run by Sichuan Academy of Medical Sciences.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 13 Mar 2026. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact rongan Liu (+8615928731511, 35279240@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (HRV) (time frame: From enrollment to the end of treatment at 48 hours). 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 NCT07470775, which also lists 22 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 13 Mar 2026.