Hemodynamic Optimalization in Pediatric Patients (HOPED)

July 26, 2023 updated by: Petr Štourač, MD, Brno University Hospital

Hemodynamic Optimalization in Pediatric Critically Ill Patients: Prospective Observational Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
    • South Moravian Region
      • Brno, South Moravian Region, Czechia, 62500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 19 years (Child, Adult)

Accepts Healthy Volunteers

N/A

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Other Names:
  • Hemodynamic optimalization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vasopressor and/or inotrope therapy effect on blood pressure
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
From date of ICU admission until the date of weaning from vasopressor and/or inotrope therapy, assessed up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of associated complications
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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
From date of ICU admission until the date of weaning from vasopressor and/or inotrope therapy, assessed up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brno University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 14, 2020

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KDAR FN Brno 2020/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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