Hemodynamic Optimalization in Pediatric Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2023-12-31

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.

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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.

Conditions

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Hemodynamic Instability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hemodynamically instable pediatric patients

Pediatric patients admitted to the pediatric intensive care unit with the need of vasopressor and/or inotrope therapy due to hemodynamic instability

Vasopressor and/inotrope therapy

Intervention Type OTHER

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

Interventions

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Vasopressor and/inotrope therapy

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

Intervention Type OTHER

Other Intervention Names

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Hemodynamic optimalization

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