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Completed

NCT Number: NCT07519226

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

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.

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Key information

Conditions

Shock Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

28 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

atropine control group

Drug

atropine control group

penehyclidine hydrochloride group

Drug

penehyclidine hydrochloride

Primary outcomes

  1. the duration of CRT(capillary refill time)

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Lihua Wen

Other

Registry information

Official study title

Effectiveness and Safety of Penehyclidine Hydrochloride for Improving Microcirculatory Dysfunction in Critically Ill Children: A Single-Center, Prospective, Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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