Fluid Responsiveness Evaluation by a Non-invasive Method in CHildren

NCT ID: NCT05919719

Last Updated: 2023-06-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-03
• Study Completion Date: 2023-02-01

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).

Detailed Description

Fluid expansion is the cornerstone of acute circulatory failure treatment in children Although this therapy drastically reduced mortality, several studies in recent years have highlighted the adverse effects of excessive fluid expansion (leading to fluid overload). Currently, the search for indicators to predict fluid responsiveness is a major issue in intensive care. These indicators are based on Franck-Starling's law: if small changes in preload lead to an increase in cardiac output, then fluid responsiveness can be expected. However, in children, the only validated indicator (respiratory variability of peak aortic velocity) can only be used in the absence of any spontaneous respiratory movement, a rare situation in practice. Recently, two pediatric studies investigated a simple clinical test: hepatic or abdominal compression. This clinical maneuver, by increasing venous return via mobilization of the hepato-splanchnic reserve, induces a transient and reversible preload increase. The evaluation of the hemodynamic effects of this "endogenous fluid expansion" allowed, according to the authors, to accurately predict fluid responsiveness. However, several factors reduce the applicability of these results: the small number of studies on this subject, the smaller volume of fluid used than in clinical practice, and the population studied, composed almost exclusively of children in postoperative of cardiac surgery.

In this study, the investigators will evaluate the diagnostic accuracy of abdominal compression for the diagnosis of fluid responsiveness in children with acute circulatory failure, hospitalized in pediatric intensive care unit (PICU) for a medical or a non-cardiac surgical condition, for whom a fluid expansion was prescribed by the physician in charge. The index test will be the stroke volume variation following a standardized abdominal compression (before fluid expansion). The gold standard test will be the variation of cardiac output between baseline and after fluid expansion, a variation > 15% defining fluid responsiveness.

In this non interventional study of diagnostic accuracy, patients will undergo an extra echocardiographic assessment, but no supplemental blood test or invasive parameters will be collected. Simple clinical parameters will be collected within 4 hours after the fluid expansion. Patients will be follow-up until PICU discharge.

Conditions

Circulatory Failure (Shock)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julien GOTCHAC, MD

Role: PRINCIPAL_INVESTIGATOR

Bordeaux hospital University

Locations

Bordeaux Hospital University

Bordeaux, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 40329198 (View on PubMed)

Other Identifiers

CHUBX 2021/48

Identifier Type: -

Identifier Source: org_study_id