ShockNCT07519226
Effectiveness and Safety of Penehyclidine Hydrochloride for Improving Microcirculatory Dysfunction in Critically Ill Children
A study testing penehyclidine hydrochloride group in people with Shock, run by Lihua Wen at 1 site in China.
Trial summary
This prospective randomized controlled trial was designed to evaluate whether the M1/M3-selective antagonist penehyclidine hydrochloride could more effectively reverse pediatric microcirculatory dysfunction than traditional atropine, particularly when macrohemodynamics appear normalized. Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Shock
- What is being tested?
- penehyclidine hydrochloride group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2024to 1 Mar 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 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- pediatric patients (aged 28 days to 18 years) admitted with shock who exhibited persistent microcirculatory impairment despite achieving macrohemodynamic stability (normalized mean arterial pressure) through standardized initial resuscitation.
- presence of at least one of the following clinical markers: (1) capillary refill time (CRT)≥ 3 seconds; (2) serum lactate > 2 mmol/L; (3) cool extremities; or (4) a core-to-peripheral temperature gradient ≥ 2°C.
Who cannot join
- refusal of informed consent;
- congenital cardiovascular malformations or known inherited metabolic disorders;
- disease severity precluding reliable microcirculatory monitoring;
- patients undergoing therapeutic hypothermia, which inherently alters vasomotor tone.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510000
About this study
Official title: Effectiveness and Safety of Penehyclidine Hydrochloride for Improving Microcirculatory Dysfunction in Critically Ill Children: A Single-Center, Prospective, Randomized Controlled Trial
This prospective randomized controlled trial was designed to evaluate whether the M1/M3-selective antagonist penehyclidine hydrochloride could more effectively reverse pediatric microcirculatory dysfunction than traditional atropine, particularly when macrohemodynamics appear normalized.
- Conditions
- Shock
- Being tested
- atropine control group, penehyclidine hydrochloride group
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atropine control groupDrug
atropine control group
penehyclidine hydrochloride groupDrug
penehyclidine hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | atropine Receives: Drug: atropine control group |
| Experimental group | Experimental | penehyclidine hydrochloride Receives: Drug: penehyclidine hydrochloride group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration of CRT(capillary refill time)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start8 May 2024
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lihua Wen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lihua Wen, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519226
- Sponsor's protocol ID
- 2023-431B00
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Penehyclidine Hydrochloride for Improving Microcirculatory Dysfunction in Critically Ill Children: A Single-Center, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07519226
- Acronym / sponsor ID
- 2023-431B00
- Conditions
- Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Lihua WenUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 9 Apr 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.
This prospective randomized controlled trial was designed to evaluate whether the M1/M3-selective antagonist penehyclidine hydrochloride could more effectively reverse pediatric microcirculatory dysfunction than traditional atropine, particularly when macrohemodynamics appear normalized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: atropine control groupatropine |
| Experimental group | Experimental | Drug: penehyclidine hydrochloride grouppenehyclidine hydrochloride |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- pediatric patients (aged 28 days to 18 years) admitted with shock who exhibited persistent microcirculatory impairment despite achieving macrohemodynamic stability (normalized mean arterial pressure) through standardized initial resuscitation.
- presence of at least one of the following clinical markers: (1) capillary refill time (CRT)≥ 3 seconds; (2) serum lactate > 2 mmol/L; (3) cool extremities; or (4) a core-to-peripheral temperature gradient ≥ 2°C.
Key exclusion criteria (4 listed)
- refusal of informed consent;
- congenital cardiovascular malformations or known inherited metabolic disorders;
- disease severity precluding reliable microcirculatory monitoring;
- patients undergoing therapeutic hypothermia, which inherently alters vasomotor tone.
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 |
|---|---|---|
| atropine control groupatropine control group | Drug | Control Group |
| penehyclidine hydrochloride grouppenehyclidine hydrochloride | Drug | Experimental group |
Primary outcome
the duration of CRT(capillary refill time)
Time frame: 7 days
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 9 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing penehyclidine hydrochloride group in people with Shock, run by Lihua Wen 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 2 inclusion and 4 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 9 Apr 2026. 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. 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?
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?
the duration of CRT(capillary refill time) (time frame: 7 days). 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 9 Apr 2026.