NCT07519226

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

April 2, 2026

Last Update Submit

April 2, 2026

Conditions

Shock

Outcome Measures

Primary Outcomes (1)

  • the duration of CRT(capillary refill time)

    7 days

Study Arms (2)

Control Group

ACTIVE COMPARATOR

atropine

Drug: atropine control group

Experimental group

EXPERIMENTAL

penehyclidine hydrochloride

Drug: penehyclidine hydrochloride group

Interventions

atropine control groupDRUG

atropine control group

Control Group
penehyclidine hydrochloride groupDRUG

penehyclidine hydrochloride

Experimental group

Eligibility Criteria

Age28 Days - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 9, 2026

Study Start

May 8, 2024

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

CN(1)