Hemodynamic Optimalization in Pediatric Patients

NCT04227821 | Unknown DMC

• 1 other identifier: KDAR FN Brno 2020/2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Instability

Keywords

Hemodynamic instability; vasopressor therapy; Pediatric patient; Norepinephrine; Epinephrine; Dobutamine

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

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

Other: Vasopressor and/inotrope therapy

Interventions

Vasopressor and/inotrope therapy 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

Also known as: Hemodynamic optimalization

Hemodynamically instable pediatric patients

Eligibility Criteria

• Age: 29 Days - 19 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• pediatric patients in selected age interval
• admitted to the pediatric intensive care unit
• hemodynamic instability with the need for vasopressor and/or inotrope therapy

You may not qualify if:

• patients with no hemodynamic instability
• patients with achieved hemodynamic stability after fluid resuscitation

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

Brno University Hospital

Brno, South Moravian, 62500, Czechia

Location

Central Study Contacts

Jozef Klučka, MD

CONTACT

532234696; Klucka.Jozef@fnbrno.cz

Petr Štourač, MD, Ph.D. assoc. Prof

CONTACT

53223440; stourac.petr@fnbrno.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 14, 2020
• Study Start: September 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

CZ (1)