General AnesthesiaPLANNNCT06909227
Relevance of Veinous Lactates to Predict Postoperative Complications in Children 0-1 Years
An observational study of General Anesthesia and Infant, run by Hôpital Armand Trousseau at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years to 1 year
- Conditions the study is for
- General Anesthesia, Infant
- What is being tested?
- surgery under general anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2025to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Children requiring a surgical procedure
Who may be able to join
- surgery under general anesthesia
- age < 1 year
Who cannot join
- ambulatory surgery
- cardiac surgery
- preoperative hemodynamic instability
- Weight < 2 kg
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Armand Trousseau University Hospital
Paris, 75012
Mireille Nasr, MD, +33667601819, mireille.nasr@aphp.fr
Mireille Nasr, MD
About this study
Official title: Relevance of Veinous Lactates Dosage at the End of a Surgical Procedure to Predict Postoperative Complications in Children 0-1 Years
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.
- Conditions
- General Anesthesia, Infant
- Being tested
- surgery under general anesthesia
- Keywords
- pediatric, anesthesia, lactate, complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery under general anesthesiaProcedure or surgery
Only in children, < 1 year old non-cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| infants 0-1 years undergoing surgery under general anesthesia | Not including day-case surgery, or cardiac surgery Receives: Procedure: surgery under general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative complications occurring within 3 months after surgery
ICU admission Re-operation Re-admission Death
Measured: within 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start27 Mar 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Armand Trousseau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr Isabelle CONSTANT, Hôpital Armand Trousseau
- Investigators
- Nada Sabourdin, MD, PhD, Study director, Armand Trousseau University HospitalIsabelle Constant, MD, PhD, Study chair, Armand Trousseau University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909227
- Sponsor's protocol ID
- PLANN
- Acronym
- PLANN
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will have to check adherence to confidentiality protocols.
Publications
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.
PubMed 38313014Stephens 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.
PubMed 32294015
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of Veinous Lactates Dosage at the End of a Surgical Procedure to Predict Postoperative Complications in Children 0-1 Years
- ClinicalTrials.gov ID
- NCT06909227
- Acronym / sponsor ID
- PLANN / PLANN
- Conditions
- General Anesthesia, Infant
- Keywords
- pediatric, anesthesia, lactate, complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hôpital Armand TrousseauUniversity, hospital or other
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infants 0-1 years undergoing surgery under general anesthesia | – | Procedure: surgery under general anesthesiaNot including day-case surgery, or cardiac surgery |
Who may qualify
- Ages
- 0 years to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children requiring a surgical procedure
Key inclusion criteria (2 listed)
- surgery under general anesthesia
- age < 1 year
Key exclusion criteria (4 listed)
- ambulatory surgery
- cardiac surgery
- preoperative hemodynamic instability
- Weight < 2 kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgery under general anesthesiaOnly in children, < 1 year old non-cardiac surgery | Procedure or surgery | infants 0-1 years undergoing surgery under general anesthesia |
Primary outcome
Post-operative complications occurring within 3 months after surgery
Time frame: within 3 months after surgery
ICU admission Re-operation Re-admission Death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Background: PubMed 38313014Zheng 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.
- Background: PubMed 32294015Stephens 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.
- Individual participant dataSharing planned: Undecided. Will have to check adherence to confidentiality protocols.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nada Sabourdin, MD, PhD study director
Armand Trousseau University Hospital
Isabelle Constant, MD, PhD study chair
Armand Trousseau University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthesia and Infant, run by Hôpital Armand Trousseau at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mireille Nasr, MD (+33667601819, mireille.nasr@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative complications occurring within 3 months after surgery (time frame: within 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06909227, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.