Investigating veinous lactate levels to predict complications after surgery in infants
Relevance of Veinous Lactates Dosage at the End of a Surgical Procedure to Predict Postoperative Complications in Children 0-1 Years
Hôpital Armand Trousseau · NCT06909227
This study is testing if measuring lactate levels in the blood after surgery can help predict complications in infants aged 0-1 year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 0 Years to 1 Year |
| Sex | All |
| Sponsor | Hôpital Armand Trousseau (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT06909227 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine the relationship between veinous lactate levels measured at the end of surgical procedures and the occurrence of postoperative complications in infants aged 0-1 years. Blood samples will be collected routinely before the emergence from general anesthesia to assess lactate levels. The hypothesis is that higher lactate levels may correlate with an increased risk of complications within three months post-surgery, similar to findings in adult populations.
Who should consider this trial
Good fit: Ideal candidates for this study are infants under one year of age who are undergoing surgery under general anesthesia.
Not a fit: Patients undergoing ambulatory or cardiac surgery, or those with preoperative hemodynamic instability or weighing less than 2 kg, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify infants at higher risk for postoperative complications, allowing for better monitoring and management.
How similar studies have performed: While the approach of using lactate levels to predict complications has been established in adults, this specific application in infants is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * surgery under general anesthesia * age \< 1 year Exclusion Criteria: * ambulatory surgery * cardiac surgery * preoperative hemodynamic instability * Weight \< 2 kg
Where this trial is running
Paris
- Armand Trousseau University Hospital — Paris, France (RECRUITING)
Study contacts
- Study coordinator: Mireille Nasr, MD
- Email: mireille.nasr@aphp.fr
- Phone: +33667601819
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: General Anesthesia, Infant, pediatric, anesthesia, lactate, complications