Hemodynamic Optimalization in Pediatric Patients

Hemodynamic Instability Clinical Trial

— HOPED  

Official title:

Hemodynamic Optimalization in Pediatric Critically Ill Patients: Prospective Observational Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04227821
• Other study ID #: KDAR FN Brno 2020/2
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Brno University Hospital
• Contact: Jozef Klucka, MD
• Phone: 532234696
• Email: Klucka.Jozef[@]fnbrno.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 29 Days to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

Other:
• 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

Locations

Country	Name	City	State
Czechia	Brno University Hospital	Brno	South Moravian Region

Sponsors (1)

Lead Sponsor	Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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