Fluid Responsiveness Evaluation by a Non-invasive Method in Children, Extended to PREterm Infants - FRENCH-PREMA

NCT06287710 | Recruiting

• 1 other identifier: CHUBX 2023/32
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators aim to validate a non-invasive marker of fluid-responsiveness in preterm infants (term below 37 gestational week) with acute circulatory failure based on standardized abdominal compression. This would allow physicians to identify which patient could benefit from a fluid expansion, thus avoiding a potentially useless or even dangerous fluid expansion, leading to fluid overload. To this end, the investigators will evaluate the diagnostic accuracy (sensitivity and specificity) of stroke volume variation induced by standardized abdominal compression for the diagnosis of fluid responsiveness (based on the gold-standard test: significant increase in cardiac index after fluid expansion).

Conditions

Premature Baby 26 to 32 Weeks; Premature Baby 33 to 36 Weeks

Keywords

Circulatory failure (shock); volume expansion; echocardiography; Shock; goal-directed fluid management; preterm infants

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness,

  Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness, defined by an increase of cardiac output \> 15% after fluid expansion (ΔCO-FE \> 15%, gold-standard test) Index test (ΔSVi-AC) will be calculated as the difference between SV after abdominal compression and SV at baseline, divided by SV at baseline (%). SV will be measured by echocardiographic assessment. Gold-standard test (ΔCO-FE) will be calculated as the difference between CO after fluid expansion and CO at baseline, divided by CO at baseline (%). CO will be measured by echocardiographic assessment. value) of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness, defined by an increase of cardiac output \> 15% after fluid expansion (ΔCO-FE \> 15%, gold-standard test)

  after abdominal compression, 30 minutes to 4 hours after baseline

Secondary Outcomes (1)

• Diagnostic accuracy of the SAV mean and the ΔPeak for the diagnosis of fluid responsiveness

  after abdominal compression, 30 minutes to 4 hours after baseline

Study Arms (1)

study of diagnostic accuracy

Patients included in this study would have received fluid expansion in all cases, as the prescription of 10 to 20ml/kg fluid expansion by the physician in charge is the main inclusion criterion.

Procedure: Non interventional study (study of diagnostic accuracy with an extra echocardiographic assessment).

Interventions

Non interventional study (study of diagnostic accuracy with an extra echocardiographic assessment). PROCEDURE

Study of diagnostic accuracy (non-interventional, prospective, monocentric). Fluid expansion will be delayed for a few minutes while our index test is performed. After fluid expansion, patient will undergo an echocardiographic assessment of response to fluid expansion (gold-standard test). This will allow to test the diagnostic performance of the index test for the "prediction" of fluid responsiveness. The index test is the ΔSVi-AC: indexed percentage of stroke volume variation between baseline and during a standardized abdominal compression. Stroke volume will be assessed by transthoracic echocardiography. Patient will undergo 3 echocardiographic assessment: At baseline (stroke volume, cardiac output, left ventricular ejection fraction), During a standardized abdominal compression (stroke volume),After the 10 to 20ml/kg fluid expansion prescribed by the physician in charge (cardiac output).

study of diagnostic accuracy

Eligibility Criteria

• Age: 1 Minute - 5 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

As this is a pilot study in a population of premature infants (term bellow 37 weeks of amenorrhea), the projected number of patients included will be 20, based on the department's active patient file, in order to have a minimum of 40 fluid expansion required for the study.

You may qualify if:

• Premature newborn under 37 weeks of amenorrhea hospitalized in neonatal intensive care
• Prescription of a 10 to 20ml/kg fluid expansion (crystalloid, blood products or albumin) by the physician in charge, whose goal would be to increase cardiac output (based on clinical, biological and/or echographic criteria).

You may not qualify if:

• Acute cardiogenic pulmonary edema
• Hemodynamic instability making the delay necessary for abdominal compression and ultrasonography dangerous for the patient
• Non corrected congenital cardiopathy, or inferior to 15 days postoperative. Intra-abdominal hypertension or painful abdominal palpation
• Abdominal surgery in the last 15 days
• Supine position contraindicated or deleterious
• No investigator available to assess ultrasonographic measures
• Impairment of echocardiographic acoustic window or restless patient making ultrasonography impossible

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Bordeaux Hospital University

Bordeaux, 33076, France

RECRUITING

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sophie CRAMAREGEAS

  Bordeaux hospital University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie CRAMAREGEAS, MD

CONTACT

0557821269; sophie.cramaregeas@chu-bordeaux.fr

Géraldine ROBERT

CONTACT

055821500; geraldine.robert@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: March 1, 2024
• Study Start: January 17, 2024
• Primary Completion: November 17, 2024
• Study Completion: April 17, 2025
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

FR (1)