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Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock (PRECISE)

Primary Purpose

Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mini-bolus
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit focused on measuring Mini-bolus challenge, fluid responsiveness, volemic expansion, pediatric septic shock, severe sepsis, microcirculation

Eligibility Criteria

28 Days - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Necker Enfants-MaladesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mini-bolus

Arm Description

First injection of 2ml/kg (saline solution) Second injection of 18ml/kg (saline solution)

Outcomes

Primary Outcome Measures

Cardiac output variability (ΔCO)
Cardiac output
Cardiac output variability (ΔCO)
Cardiac output : ΔCO (mL/min) = VES (ml)* heart rate and VES (cm3)= ITVA0(cm) * SA0 (cm2)

Secondary Outcome Measures

Heart rate variation (ΔHR)
Heart rate usual monitoring
Systolic, diastolic and mean arterial pressure variation (ΔSAP, ΔDAP, ΔMAP)
Arterial pressure invasive or not invasive monitoring according the care of patient
Systolic, diastolic and mean arterial pressure variation (ΔSAP, ΔDAP, ΔMAP)
Arterial pressure invasive or not invasive monitoring according the care of patient
Pulse pressure variation (ΔPP)
Pulse pressure invasive or not invasive monitoring according the care of patient
Pulse pressure variation (ΔPP)
Pulse pressure invasive or not invasive monitoring according the care of patient
Systolic ejection volume variation (ΔSEV)
Systolic ejection volume is measured by transthoracic echocardiography : VES (ml) =ITVa0*Sa0
Systolic ejection volume variation (ΔSEV)
Systolic ejection volume is measured by transthoracic echocardiography : VES (ml) =ITVa0*Sa0
Velocity time-index variation (ΔVTI)
ITVA0 is measured by transthoracic echocardiography with Doppler
Velocity time-index variation (ΔVTI)
ITVA0 is measured by transthoracic echocardiography with Doppler
Microvascular Flow Index variation (ΔMFI)
Microvascular Flow Index calculated by the Microscan software (Microvision)
Microvascular Flow Index variation (ΔMFI)
Microvascular Flow Index calculated by the Microscan software (Microvision)
Proportion Perfused Vessels variation (ΔPPV)
Proportion Perfused Vessels calculated by the Microscan software (Microvision)

Full Information

First Posted
July 18, 2019
Last Updated
February 10, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04027699
Brief Title
Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock
Acronym
PRECISE
Official Title
Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 , the volume expansion is considered effective if it allows an increase in cardiac output of more than 15 % compared to the basal level. However, their conditions of use remain very restrictive and not applicable to most of our patients ( tidal volume ≥ 7ml / kg , PEEP sufficient , absence of cardiac arrhythmia and effective sedation ) . To date , no index can be used for all patients with invasive mechanical ventilation. It therefore seems appropriate to develop new tests to predict the response to volume expansion in children with septic shock hospitalized in pediatric intensive care. A recent study has validated a test to predict the response to volume expansion in adults: injection of a mini-bolus of 50 ml of saline over 10s. The aim of the study is to evaluate the effect of mini bolus fluid to predict response to fluid expansion in pediatric septic shock.
Detailed Description
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 , the volume expansion is considered effective if it allows an increase in cardiac output of more than 15 % compared to the basal level . However , their conditions of use remain very restrictive and not applicable to most of our patients ( tidal volume > 7ml / kg , PEEP sufficient, absence of cardiac arrhythmia and effective sedation ) . To date , no index can be used for all patients with invasive mechanical ventilation . It therefore seems appropriate to develop new tests to predict the response to volume expansion in children with septic shock hospitalized in pediatric intensive care. A recent study has validated a test to predict the response to volume expansion in adults : injection of a mini-bolus of 50 ml of saline over 10s. The aim of the study is to evaluate the effect of mini bolus fluid to predict response to fluid expansion in pediatric septic shock.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit
Keywords
Mini-bolus challenge, fluid responsiveness, volemic expansion, pediatric septic shock, severe sepsis, microcirculation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mini-bolus
Arm Type
Experimental
Arm Description
First injection of 2ml/kg (saline solution) Second injection of 18ml/kg (saline solution)
Intervention Type
Procedure
Intervention Name(s)
Mini-bolus
Intervention Description
First injection of 2ml/kg (saline solution) Second injection of 18ml/kg (saline solution)
Primary Outcome Measure Information:
Title
Cardiac output variability (ΔCO)
Description
Cardiac output
Time Frame
5 minutes
Title
Cardiac output variability (ΔCO)
Description
Cardiac output : ΔCO (mL/min) = VES (ml)* heart rate and VES (cm3)= ITVA0(cm) * SA0 (cm2)
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Heart rate variation (ΔHR)
Description
Heart rate usual monitoring
Time Frame
15 minutes
Title
Systolic, diastolic and mean arterial pressure variation (ΔSAP, ΔDAP, ΔMAP)
Description
Arterial pressure invasive or not invasive monitoring according the care of patient
Time Frame
5 minutes
Title
Systolic, diastolic and mean arterial pressure variation (ΔSAP, ΔDAP, ΔMAP)
Description
Arterial pressure invasive or not invasive monitoring according the care of patient
Time Frame
15 minutes
Title
Pulse pressure variation (ΔPP)
Description
Pulse pressure invasive or not invasive monitoring according the care of patient
Time Frame
5 minutes
Title
Pulse pressure variation (ΔPP)
Description
Pulse pressure invasive or not invasive monitoring according the care of patient
Time Frame
15 minutes
Title
Systolic ejection volume variation (ΔSEV)
Description
Systolic ejection volume is measured by transthoracic echocardiography : VES (ml) =ITVa0*Sa0
Time Frame
5 minutes
Title
Systolic ejection volume variation (ΔSEV)
Description
Systolic ejection volume is measured by transthoracic echocardiography : VES (ml) =ITVa0*Sa0
Time Frame
15 minutes
Title
Velocity time-index variation (ΔVTI)
Description
ITVA0 is measured by transthoracic echocardiography with Doppler
Time Frame
5 minutes
Title
Velocity time-index variation (ΔVTI)
Description
ITVA0 is measured by transthoracic echocardiography with Doppler
Time Frame
15 minutes
Title
Microvascular Flow Index variation (ΔMFI)
Description
Microvascular Flow Index calculated by the Microscan software (Microvision)
Time Frame
5 minutes
Title
Microvascular Flow Index variation (ΔMFI)
Description
Microvascular Flow Index calculated by the Microscan software (Microvision)
Time Frame
15 min
Title
Proportion Perfused Vessels variation (ΔPPV)
Description
Proportion Perfused Vessels calculated by the Microscan software (Microvision)
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Baby (>28 days) or children < 15 years Hospitalisation in paediatric intensive Clinico-biological table compatible with severe sepsis or septic shock (likely or documented) Requiring the use of invasive mechanical ventilation Affiliate or beneficiary of a social security Legal guardians Consent Form or Emergency Procedure Exclusion Criteria: Any serious hemodynamic clinical situation that would be delayed by inclusion in the protocol Patient with shunt heart disease Patient in spontaneous or non-invasive ventilation or CPAP Patient with a contraindication to volemic/fluid expansion (major cardiac dysfunction, acute renal failure) Patient with cardiac arrest upper 5 min ECMO Postcardiotomia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre-Louis Léger, MD-PhD
Phone
+33 1 71 73 83 73
Email
pierre-louis.leger@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Aminata TRAORE
Phone
+33 1 48 19 27 34
Email
aminata.traore6@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Dupic, MD
Organizational Affiliation
APHP
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital Necker Enfants-Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Louis Léger, PH
Phone
+33 1 71 73 83 73
Email
pierre-louis.leger@aphp.fr
First Name & Middle Initial & Last Name & Degree
Sandra Colas
Phone
+33 1 71 19 64 32
Email
sandra.colas@aphp.fr

12. IPD Sharing Statement

Learn more about this trial

Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock

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