Hemodynamic Optimalization in Pediatric Patients

Study Overview
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Brief Summary
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Hemodynamic unstability, defined by macrocirculation and/or microcirculation dysfunction or alteration is common in critically ill pediatric patients. The initial treatment of hemodynamically unstable patient is the fluid resuscitation (fluid challenge therapy). However, the stabilization of hemodynamics only with fluid resuscitation can be achieved in less than 50% pediatric patients. In case of persistent hypotension (defined as mean arterial pressure below 65 mmHg, or by the formula - 55 + 1,5 x age in years), or in case of persistent lactate levels and base deficit elevation is the catecholamine therapy method of choice in case of sufficiently restored intravascular volume. In adult patients, the drug of choice (the first line therapy of persistent hypotension) is considered norepinephrine (based on evidence-based data). The norepinephrine is administered intravenously in form of continuous infusion, with the dose adjusted to the target level of mean arterial pressure (MAP). It should be preferably administered through the central venous catheter to minimize the complications associated with the damage of the peripheral vein wall damage in case of administered into the peripheral vein. Due to lack of evidence-based data (EBM) for pediatric population, there is still significant heterogenity of clinical practice and dobutamin, dopamine, norepinephrine and epinephrine are being used for hemodynamically unstable pediatric patient.

Detailed Description
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After Ethics committee approval, pediatric patients admitted to the Departement of pediatric anesthesiology and intensive care with the need of vasopressor and/or inotrope therapy in the selected study period will be included. The primary aim of the trial is the describe the therapy effect on the vital signs (heart rate, blood pressure), level of lactate and base deficit in 1,3,6,12,24,48 and every other 24th hours. The secondary aim of the trial is the incidence of complications: arrythmias, hypertension, defects of peripheral perfusion, mortality, renal failure, the PELOD-2 and pSOFA score at admission and every next 24 hours. The cumulative overall dose and the cumulative 24 hours dose of vasopressors/inotropes will be recorded.

Official Title
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Hemodynamic Optimalization in Pediatric Critically Ill Patients: Prospective Observational Trial

Conditions
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Hemodynamic Instability

Intervention / Treatment
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* Other: Vasopressor and/inotrope therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pediatric patients in selected age interval admitted to the pediatric intensive care unit hemodynamic instability with the need for vasopressor and/or inotrope therapy Exclusion Criteria: patients with no hemodynamic instability patients with achieved hemodynamic stability after fluid resuscitation

Ages Eligible for Study
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Minimum Age: 29 Days
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hemodynamically instable pediatric patients<br>Pediatric patients admitted to the pediatric intensive care unit with the need of vasopressor and/or inotrope therapy due to hemodynamic instability | Other: Vasopressor and/inotrope therapy<br>* In pediatric patients admitted to the pediatric intensive care, with the persistent hemodynamic instability after fluid resuscitation, the vasopressor and/or inotrope therapy will be initiated<br>* Other names: Hemodynamic optimalization;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vasopressor and/or inotrope therapy effect on blood pressure | Blood pressure will be measured during ICU stay | From date of ICU admission until the date of weaning from vasopressor and/or inotrope therapy, assessed up to 1 month | 
| Vasopressor and/or inotrope therapy effect on levels of lactate | blood levels of lactate will be measured during ICU stay | From date of ICU admission until the date of weaning from vasopressor and/or inotrope therapy, assessed up to 1 month | 
| Vasopressor and/or inotrope therapy effect on blood levels of base deficit | blood levels of base deficit will be measured during ICU stay | From date of ICU admission until the date of weaning from vasopressor and/or inotrope therapy, assessed up to 1 month | 
| Vasopressor and/or inotrope therapy effect on heart rate | Heart rate will be measured during ICU stay | From date of ICU admission until the date of weaning from vasopressor and/or inotrope therapy, assessed up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of associated complications | The incidence of arrythmias, hypertension, defects of peripheral perfusion, renal failure will be measured during the therapy | From date of ICU admission until the date of weaning from vasopressor and/or inotrope therapy, assessed up to 1 month | 
| Change in Pediatric Logistic Organ Dysfunction-2 (PELOD-2 score) | The Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score will be measured every day from ICU admission until ICU discharge | From date of ICU admission until the date of weaning from vasopressor and/or inotrope therapy, assessed up to 1 month | 
| Change in The Pediatric Sequential Organ Failure Assessment (pSOFA) | The Pediatric Sequential Organ Failure Assessment (pSOFA) score will be measured every day every day from ICU admission until ICU discharge | From date of ICU admission until the date of weaning from vasopressor and/or inotrope therapy, assessed up to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodynamic instability, vasopressor therapy, Pediatric patient, Norepinephrine, Epinephrine, Dobutamine