Clinical trial NCT04227821: Hemodynamic Optimalization in Pediatric Patients
Official title: Hemodynamic Optimalization in Pediatric Critically Ill Patients: Prospective Observational Trial
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hemodynamic Instability
Keywords: Hemodynamic instability
vasopressor therapy
Pediatric patient
Norepinephrine
Epinephrine
Dobutamine
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 100
Sex: ALL
Minimum age (years): 29
Maximum age (years): 19
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill pediatric patients admitted to the pediatric intensive care unit with persitent hemodynamic instability despite adequate volume resuscitation

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Vasopressor and/or inotrope therapy effect on blood pressure
timeFrame: From date of ICU admission until the date of weaning from vasopressor and/or inotrope therapy, assessed up to 1 month
measure: Vasopressor and/or inotrope therapy effect on levels of lactate
timeFrame: From date of ICU admission until the date of weaning from vasopressor and/or inotrope therapy, assessed up to 1 month
measure: Vasopressor and/or inotrope therapy effect on blood levels of base deficit
timeFrame: From date of ICU admission until the date of weaning from vasopressor and/or inotrope therapy, assessed up to 1 month
measure: Vasopressor and/or inotrope therapy effect on heart rate
timeFrame: From date of ICU admission until the date of weaning from vasopressor and/or inotrope therapy, assessed up to 1 month
Secondary outcomes:
measure: Incidence of associated complications
timeFrame: From date of ICU admission until the date of weaning from vasopressor and/or inotrope therapy, assessed up to 1 month
measure: Change in Pediatric Logistic Organ Dysfunction-2 (PELOD-2 score)
timeFrame: From date of ICU admission until the date of weaning from vasopressor and/or inotrope therapy, assessed up to 1 month
measure: Change in The Pediatric Sequential Organ Failure Assessment (pSOFA)
timeFrame: From date of ICU admission until the date of weaning from vasopressor and/or inotrope therapy, assessed up to 1 month
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital
state: South Moravian Region
Study officials:
References: