Hemodynamic Optimalization in Pediatric Patients (HOPED)

Brno University Hospital

Status: Not yet enrolling

Conditions: Hemodynamic Instability

Treatments: Other: Vasopressor and/inotrope therapy

Study type: Observational

Funder types: Other

Identifiers

NCT04227821

KDAR FN Brno 2020/2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 29 days to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Hemodynamically instable pediatric patients

Description:

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

Treatment:

Other: Vasopressor and/inotrope therapy