Relevance of Veinous Lactates to Predict Postoperative Complications in Children 0-1 Years

NCT ID: NCT06909227

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-27

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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General Anesthesia Infant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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infants 0-1 years undergoing surgery under general anesthesia

Not including day-case surgery, or cardiac surgery

surgery under general anesthesia

Intervention Type PROCEDURE

Only in children, \< 1 year old non-cardiac surgery

Interventions

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surgery under general anesthesia

Only in children, \< 1 year old non-cardiac surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* surgery under general anesthesia
* age \< 1 year

Exclusion Criteria

* ambulatory surgery
* cardiac surgery
* preoperative hemodynamic instability
* Weight \< 2 kg
Minimum Eligible Age

0 Years

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital Armand Trousseau

OTHER

Sponsor Role lead

Responsible Party

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Pr Isabelle CONSTANT

Professor of Anesthesiology, Head of Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nada Sabourdin, MD, PhD

Role: STUDY_DIRECTOR

Armand Trousseau University Hospital

Isabelle Constant, MD, PhD

Role: STUDY_CHAIR

Armand Trousseau University Hospital

Locations

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Armand Trousseau University Hospital

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mireille Nasr, MD

Role: CONTACT

+33667601819

Nada Sabourdin, MD, PhD

Role: CONTACT

+33667185789

Facility Contacts

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Mireille Nasr, MD

Role: primary

+33667601819

References

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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.

Reference Type BACKGROUND
PMID: 38313014 (View on PubMed)

Stephens 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.

Reference Type BACKGROUND
PMID: 32294015 (View on PubMed)

Other Identifiers

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PLANN

Identifier Type: -

Identifier Source: org_study_id

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