Hemodynamic InstabilityHOPEDNCT04227821
Hemodynamic Optimalization in Pediatric Patients
An observational study of Hemodynamic Instability, run by Brno University Hospital at 1 site in Czechia.
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). Read more about this study
- Who is it for?
- Ages 29 days to 19 years
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Vasopressor and/inotrope therapy
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 19 years
- All sexes
- Child, Adult
Study population: Critically ill pediatric patients admitted to the pediatric intensive care unit with persitent hemodynamic instability despite adequate volume resuscitation
Who may be able to join
- pediatric patients in selected age interval
- admitted to the pediatric intensive care unit
- hemodynamic instability with the need for vasopressor and/or inotrope therapy
Who cannot join
- patients with no hemodynamic instability
- patients with achieved hemodynamic stability after fluid resuscitation
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Brno University Hospital
Brno, South Moravian, 62500
Petr Štourač, doc.MD.P.hD., 532234404 ext. 00420, stourac.petr@fnbrno.cz
Jozef Klučka, MD, 532234696 ext. 00420, klucka.jozef@fnbrno.cz
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemodynamic Instability
- Being tested
- Vasopressor and/inotrope therapy
- Keywords
- Hemodynamic instability, vasopressor therapy, Pediatric patient, Norepinephrine, Epinephrine, Dobutamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vasopressor and/inotrope therapyOther
Also called Hemodynamic optimalization
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Vasopressor and/inotrope therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasopressor and/or inotrope therapy effect on blood pressure
Blood pressure will be measured during ICU stay
Measured: 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
Measured: 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
Measured: 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
Measured: 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
The incidence of arrythmias, hypertension, defects of peripheral perfusion, renal failure will be measured during the therapy
Measured: 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)
The Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score will be measured every day from ICU admission until ICU discharge
Measured: 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)
The Pediatric Sequential Organ Failure Assessment (pSOFA) score will be measured every day every day from ICU admission until ICU discharge
Measured: From date of ICU admission until the date of weaning from vasopressor and/or inotrope therapy, assessed up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start1 Sep 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227821
- Sponsor's protocol ID
- KDAR FN Brno 2020/2
- Acronym
- HOPED
- Status last verified
- Jul 2023
- First submitted
- 8 Jan 2020
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Optimalization in Pediatric Critically Ill Patients: Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT04227821
- Acronym / sponsor ID
- HOPED / KDAR FN Brno 2020/2
- Conditions
- Hemodynamic Instability
- Keywords
- Hemodynamic instability, vasopressor therapy, Pediatric patient, Norepinephrine, Epinephrine, Dobutamine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodynamically instable pediatric patients | – | Other: Vasopressor and/inotrope therapyPediatric patients admitted to the pediatric intensive care unit with the need of vasopressor and/or inotrope therapy due to hemodynamic instability |
Who may qualify
- Ages
- 29 days to 19 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Critically ill pediatric patients admitted to the pediatric intensive care unit with persitent hemodynamic instability despite adequate volume resuscitation
Key inclusion criteria (3 listed)
- pediatric patients in selected age interval
- admitted to the pediatric intensive care unit
- hemodynamic instability with the need for vasopressor and/or inotrope therapy
Key exclusion criteria (2 listed)
- patients with no hemodynamic instability
- patients with achieved hemodynamic stability after fluid resuscitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vasopressor and/inotrope therapyAlso: Hemodynamic optimalizationIn 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 | Hemodynamically instable pediatric patients |
Primary outcome
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
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
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
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
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamic Instability, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jozef Klučka, MD (532234696 ext. 00420, Klucka.Jozef@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.