Cyclohexanone and metabolites exposure in critically Ill neonates and children.

Summary

Prospective pediatric ICU and multicenter neonatal data show cyclohexanone is present in all tested IV solutions and detectable in every patient sample, with higher levels in urine than plasma. In preterm neonates, parent compound peaks on day 1, whereas metabolites peak on days 7–14, indicating sustained biotransformation. Findings highlight an urgent need for device/material substitution and mitigation strategies.

Key Findings

• Cyclohexanone was detected in all tested IV solutions used in standard ICU care (fluids, medications, dialysate, RBC bags).
• Cyclohexanone and its metabolites were present in every plasma and urine sample; urine concentrations exceeded plasma in both cohorts.
• In preterm neonates, parent compound peaked on day 1, while metabolite levels peaked on days 7–14, indicating ongoing metabolism/exposure.

Clinical Implications

Clinicians should minimize unnecessary IV tubing/line changes, prefer non-solvent bonding technologies where available, and advocate for vendor transparency on solvent content. Risk-benefit discussions are warranted in neonatal/pediatric ICU, and institutions should engage in procurement that prioritizes low-exposure devices.

Limitations

• Single-center pediatric ICU and secondary analysis for neonates may limit generalizability.
• No direct linkage to clinical outcomes or long-term neurodevelopmental effects.

Future Directions

Develop and test solvent-free or low-leach device technologies; quantify dose–response and clinical outcomes; conduct multicenter regulatory-grade exposure assessments to guide standards.