Effectiveness and Safety of Penehyclidine Hydrochloride for Improving Microcirculatory Dysfunction in Critically Ill Children

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.

Study Overview

• Status: Completed
• Conditions: Shock
• Intervention / Treatment: Drug: atropine control group; Drug: penehyclidine hydrochloride group

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Guangzhou Women And Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. 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.

Exclusion Criteria:

1. refusal of informed consent;
2. congenital cardiovascular malformations or known inherited metabolic disorders;
3. disease severity precluding reliable microcirculatory monitoring;
4. patients undergoing therapeutic hypothermia, which inherently alters vasomotor tone.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; atropine	Drug: atropine control group; atropine control group
Experimental: Experimental group; penehyclidine hydrochloride	Drug: penehyclidine hydrochloride group; penehyclidine hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the duration of CRT(capillary refill time)	7 days

Collaborators and Investigators

• Sponsor: Lihua Wen

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2024
• Primary Completion (Actual): March 1, 2026
• Study Completion (Actual): March 1, 2026

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock
• Other Study ID Numbers: 2023-431B00

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No