CompletedNot Applicable

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

China98 participantsStarted 2024-05-08

Plain-language 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.

Who can participate

Age range28 Days – 18 Years

SexALL

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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.

What they're measuring

the duration of CRT(capillary refill time)

Timeframe: 7 days

Trial details

NCT IDNCT07519226

SponsorLihua Wen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-01

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