Relevance of Veinous Lactates to Predict Postoperative Complications in Children 0-1 Years
PLANN
1 other identifier
observational
500
1 country
1
Brief Summary
This study will investigate if the dosage of veinous lactate at the end of a surgical procedure is related to post-operative complications occurring within 3 months in young infants aged 0-1 years. Blood samples are acquired routinely before emergence of general anesthesia, from the IV line put in place for anesthesia. The investigators hypothesized that elevated lactates would be associated with more postoperative complications in this population, as is the case in adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2025
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2025
CompletedStudy Start
First participant enrolled
March 27, 2025
CompletedFirst Posted
Study publicly available on registry
April 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
May 1, 2025
April 1, 2025
1.5 years
March 27, 2025
April 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-operative complications occurring within 3 months after surgery
ICU admission Re-operation Re-admission Death
within 3 months after surgery
Study Arms (1)
infants 0-1 years undergoing surgery under general anesthesia
Not including day-case surgery, or cardiac surgery
Interventions
Only in children, \< 1 year old non-cardiac surgery
Eligibility Criteria
Children requiring a surgical procedure
You may qualify if:
- surgery under general anesthesia
- age \< 1 year
You may not qualify if:
- ambulatory surgery
- cardiac surgery
- preoperative hemodynamic instability
- Weight \< 2 kg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Armand Trousseau University Hospital
Paris, 75012, France
Related Publications (2)
Zheng D, Yu GL, Zhou YP, Zhang QM, Wang CG, Zhang S. Association between lactic acidosis and multiple organ dysfunction syndrome after cardiopulmonary bypass. PeerJ. 2024 Jan 31;12:e16769. doi: 10.7717/peerj.16769. eCollection 2024.
PMID: 38313014BACKGROUNDStephens EH, Epting CL, Backer CL, Wald EL. Hyperlactatemia: An Update on Postoperative Lactate. World J Pediatr Congenit Heart Surg. 2020 May;11(3):316-324. doi: 10.1177/2150135120903977.
PMID: 32294015BACKGROUND
Study Officials
- STUDY DIRECTOR
Nada Sabourdin, MD, PhD
Armand Trousseau University Hospital
- STUDY CHAIR
Isabelle Constant, MD, PhD
Armand Trousseau University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Anesthesiology, Head of Department
Study Record Dates
First Submitted
March 27, 2025
First Posted
April 3, 2025
Study Start
March 27, 2025
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
May 1, 2025
Record last verified: 2025-04