Fluid Responsiveness Evaluation by a Non-invasive Method in CHildren

NCT05919719 | Completed

• 1 other identifier: CHUBX 2021/48
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators aim to validate a non-invasive marker of fluid-responsiveness in children 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

Circulatory Failure (Shock)

Keywords

shock; volume expansion; goal-directed fluid management; echocardiography

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness

  Diagnostic accuracy 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 Stroke Volume (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.

  after abdominal compression, 30 minutes to 4 hours after baseline

Secondary Outcomes (12)

• Association between elevated ΔSVi-AC and capillary filling time (sec) -Baseline

  at baseline (before fluid expansion)

• Association between elevated ΔSVi-AC and capillary filling time (sec) -after abdominal compression

  after abdominal compression, 30 minutes to 4 hours after baseline

• Association between elevated ΔSVi-AC and Heart rate (bpm). -Baseline

  at baseline (before fluid expansion)

• Association between elevated ΔSVi-AC and Heart rate (bpm). -after abdominal compression

  after abdominal compression, 30 minutes to 4 hours after baseline

• Association between elevated ΔSVi-AC and Mean blood pressure (mmHg). -Baseline

  at baseline (before fluid expansion)

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 crystalloid 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

Fluid expansion will be delayed while our index test is performed. After fluid expansion, patient will undergo an echocardiographic assessment of response to fluid expansion (gold-standard). Our 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, During abdominal compression, After the 10 to 20ml/kg crystalloid fluid expansion Abdominal compression : a sphygmomanometer will be inflated to a pressure of less than 10 mmHg and will be applied to the center of the patient's abdomen. Then, a gentle compression on the sphygmomanometer will be performed, calibrated at 22 - 26 mmHg according to the sphygmomanometer. The echocardiographic assessments will take place between 10 and 60 seconds after the start of the compression, which will therefore last less than a minute.

study of diagnostic accuracy

Eligibility Criteria

• Age: 1 Minute - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

At least 24 fluid expansion are needed, in 10 to 24 patients (maximum of 3 fluid expansion per patient). The "number needed to treat" was calculated with Obuchowski method, with an aphla risk of 0.05, a statistical power of 80%, a ratio "responder/nonresponder" of 1:1, and a predicted area under the receiver operating characteristic curve of 0.78 (based on previous studies). In order to be clinically relevant, since a large majority of patients admitted to our PICU are under 2 years of age, the investigators plan to include 24 fluid expansions administrated to patients under 2 years old. Therefore, the investigators might include more than 24 fluid expansions if some are administrated to patients older than 2 years old. Without this correction, our study might be underpowered if age is found to be a bias in fluid responsiveness.

You may qualify if:

• Age lower than 15 years old
• Prescription of a 10 to 20ml/kg crystalloid fluid expansion by the physician in charge
• Acute circulatory failure defined by the association of an A criteria (increase of heart rate more than two standard deviation for the age, decrease of systolic or mean blood pressure more than two standard deviation for ) and a B criteria (lactate more than 2 mmol/L, oliguria less than 1mL/kg/h, a capillary filling time more than 3 seconds, mottling)
• Patient hospitalized in PICU

You may not qualify if:

• Prematurity (term below 37 gestational week).
• 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

Location

Related Publications (1)

• Gotchac J, Navion A, Belaroussi Y, Klifa R, Amedro P, Guichoux J, Brissaud O. Clinical value of calibrated abdominal compression plus transthoracic echocardiography to predict fluid responsiveness in critically ill infants: a diagnostic accuracy study. BMC Pediatr. 2025 May 7;25(1):361. doi: 10.1186/s12887-025-05728-z.

  PMID: 40329198 DERIVED

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julien GOTCHAC, MD

  Bordeaux hospital University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 26, 2023
• Study Start: February 3, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

FR (1)