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Search / Trial NCT04027699

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

Mini Bolus Challenge Fluid Responsiveness Volemic Expansion Pediatric Septic Shock Severe Sepsis Microcirculation

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.

Locations

Paris, , France

Patients applied

0 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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