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Recruiting NCT05220709

NCT05220709 Bio Impedance Monitoring as a Tool to Assess Fluid Status in the Pediatric Surgical Patient? (PedFluid Study)

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Clinical Trial Summary
NCT ID NCT05220709
Status Recruiting
Phase
Sponsor University Hospital, Antwerp
Condition Fluid and Electrolyte Imbalance
Study Type INTERVENTIONAL
Enrollment 100 participants
Start Date 2022-04-05
Primary Completion 2025-12-30

Eligibility & Interventions

Sex All sexes
Min Age 1 Month
Max Age 16 Years
Study Type INTERVENTIONAL
Interventions
bio impedance spectroscopy by means of the Body Composition Monitor (Name of the device is BCM from Fresenius Medical Care D GmbH)

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 100 participants in total. It began in 2022-04-05 with a primary completion date of 2025-12-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The baseline infusion rate during surgery for pediatric patients still is the 'Holliday and Segar' rule (also known as the 4/2/1 rule) The question arises if this rule is not outdated, since it was calculated based on the caloric need of the pediatric population, calculated for cow milk. The study tends to validate the use of bio impedance measurements for registering fluid shifts in the pediatric surgical patients.

Eligibility Criteria

Inclusion Criteria: * Scheduled for elective surgery or investigation under general anesthesia * Day care or inpatient hospitalisation Exclusion Criteria: * If sedation is needed instead of general anesthesia * Critically ill patients for urgent surgery * Patients who cannot lie still for performing correct measurements on the bio impedance monitor * No informed consent obtained

Contact & Investigator

Central Contact

Vera Saldien, MD, PhD

✉ vera.saldien@uza.be

📞 38214788

Principal Investigator

Vera Saldien, MD,PhD

PRINCIPAL INVESTIGATOR

University Hospital, Antwerp

Frequently Asked Questions

Who can join the NCT05220709 clinical trial?

This trial is open to participants of all sexes, aged 1 Month or older, up to 16 Years, studying Fluid and Electrolyte Imbalance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05220709 currently recruiting?

Yes, NCT05220709 is actively recruiting participants. Contact the research team at vera.saldien@uza.be for enrollment information.

Where is the NCT05220709 trial being conducted?

This trial is being conducted at Edegem, Belgium.

Who is sponsoring the NCT05220709 clinical trial?

NCT05220709 is sponsored by University Hospital, Antwerp. The principal investigator is Vera Saldien, MD,PhD at University Hospital, Antwerp. The trial plans to enroll 100 participants.

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