免费获得国外相关药品，最快 1 个工作日回馈药物信息
Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock (PRECISE)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit | Procedure: Mini-bolus | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 80 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock |
| Actual Study Start Date : | February 23, 2021 |
| Estimated Primary Completion Date : | February 2023 |
| Estimated Study Completion Date : | March 2023 |
| Arm | Intervention/treatment |
|---|---|
Experimental: Mini-bolus
|
Procedure: Mini-bolus
|
- Cardiac output variability (ΔCO) [ Time Frame: 5 minutes ]Cardiac output
- Cardiac output variability (ΔCO) [ Time Frame: 15 minutes ]Cardiac output : ΔCO (mL/min) = VES (ml)* heart rate and VES (cm3)= ITVA0(cm) * SA0 (cm2)
- Heart rate variation (ΔHR) [ Time Frame: 15 minutes ]Heart rate usual monitoring
- Systolic, diastolic and mean arterial pressure variation (ΔSAP, ΔDAP, ΔMAP) [ Time Frame: 5 minutes ]Arterial pressure invasive or not invasive monitoring according the care of patient
- Systolic, diastolic and mean arterial pressure variation (ΔSAP, ΔDAP, ΔMAP) [ Time Frame: 15 minutes ]Arterial pressure invasive or not invasive monitoring according the care of patient
- Pulse pressure variation (ΔPP) [ Time Frame: 5 minutes ]Pulse pressure invasive or not invasive monitoring according the care of patient
- Pulse pressure variation (ΔPP) [ Time Frame: 15 minutes ]Pulse pressure invasive or not invasive monitoring according the care of patient
- Systolic ejection volume variation (ΔSEV) [ Time Frame: 5 minutes ]
Systolic ejection volume is measured by transthoracic echocardiography :
VES (ml) =ITVa0*Sa0
- Systolic ejection volume variation (ΔSEV) [ Time Frame: 15 minutes ]
Systolic ejection volume is measured by transthoracic echocardiography :
VES (ml) =ITVa0*Sa0
- Velocity time-index variation (ΔVTI) [ Time Frame: 5 minutes ]ITVA0 is measured by transthoracic echocardiography with Doppler
- Velocity time-index variation (ΔVTI) [ Time Frame: 15 minutes ]ITVA0 is measured by transthoracic echocardiography with Doppler
- Microvascular Flow Index variation (ΔMFI) [ Time Frame: 5 minutes ]Microvascular Flow Index calculated by the Microscan software (Microvision)
- Microvascular Flow Index variation (ΔMFI) [ Time Frame: 15 min ]Microvascular Flow Index calculated by the Microscan software (Microvision)
- Proportion Perfused Vessels variation (ΔPPV) [ Time Frame: 5 minutes ]Proportion Perfused Vessels calculated by the Microscan software (Microvision)
| Ages Eligible for Study: | up to 15 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| Contact: Pierre-Louis Léger, MD-PhD | +33 1 71 73 83 73 | pierre-louis.leger@aphp.fr | |
| Contact: Sandra Colas | +33 1 71 19 64 32 | sandra.colas@aphp.fr |
| France | |
| Hôpital Necker Enfants-Malades | Recruiting |
| Paris, France, 75015 | |
| Contact: Pierre-Louis Léger, PH +33 1 71 73 83 73 pierre-louis.leger@aphp.fr | |
| Contact: Sandra Colas +33 1 71 19 64 32 sandra.colas@aphp.fr | |
| Study Chair: | Laurent Dupic, MD | APHP |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 18, 2019 | ||||||||
| First Posted Date ICMJE | July 22, 2019 | ||||||||
| Last Update Posted Date | April 5, 2021 | ||||||||
| Actual Study Start Date ICMJE | February 23, 2021 | ||||||||
| Estimated Primary Completion Date | February 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
||||||||
| Original Primary Outcome Measures ICMJE |
|
||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE |
|
||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock | ||||||||
| Official Title ICMJE | Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock | ||||||||
| 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. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit | ||||||||
| Intervention ICMJE | Procedure: Mini-bolus
|
||||||||
| Study Arms ICMJE | Experimental: Mini-bolus
Intervention: Procedure: Mini-bolus
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
80 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | March 2023 | ||||||||
| Estimated Primary Completion Date | February 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | up to 15 Years (Child) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04027699 | ||||||||
| Other Study ID Numbers ICMJE | PRECISE | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| PRS Account | Assistance Publique - Hôpitaux de Paris | ||||||||
| Verification Date | April 2021 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
