Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jul 18, 2019
Trial Information
Current as of May 21, 2025
Completed
Keywords
ClinConnect Summary
Severe sepsis and septic shock remain of particular gravity in children with a current mortality of about 20 % , despite the international prevention campaigns " survival sepsis campaign " . Septic shock associates a macrocirculatory and a microcirculatory dysfunction. The volume expansion remains the treatment of severe sepsis at the initial phase supplemented by the use of vasopressors and / or inotropes . Nevertheless , it is essential to predict the fluid responsiveness after volemic expansion because fluid overload is associated with an increased morbidity in children . In studies , th...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Baby (\>28 days) or children \< 15 years
- • 2. Hospitalisation in paediatric intensive
- • 3. Clinico-biological table compatible with severe sepsis or septic shock (likely or documented)
- • 4. Requiring the use of invasive mechanical ventilation
- • 5. Affiliate or beneficiary of a social security
- • 6. Legal guardians Consent Form or Emergency Procedure
- Exclusion Criteria:
- • 1. Any serious hemodynamic clinical situation that would be delayed by inclusion in the protocol
- • 2. Patient with shunt heart disease
- • 3. Patient in spontaneous or non-invasive ventilation or CPAP
- • 4. Patient with a contraindication to volemic/fluid expansion (major cardiac dysfunction, acute renal failure)
- • 5. Patient with cardiac arrest upper 5 min
- • 6. ECMO
- • 7. Postcardiotomia
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, , France
Patients applied
Trial Officials
Laurent Dupic, MD
Study Chair
APHP
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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