Hemodynamic Optimalization in Pediatric Patients

Not yet recruiting

• Conditions: Hemodynamic Instability

• Registration Number: NCT04227821
• Lead Sponsor: Brno University Hospital

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.

Study Timeline

• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-14
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-27
• Study Start: 2023-09-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Brno University Hospital; 🇨🇿 Brno, South Moravian Region, Czechia