Hypotension and ShockNCT03671070
Role of Low Dose Epinephrine Boluses In Acute Hypotension
A study testing Epinephrine and Traditional management of shock in people with Hypotension and Shock, run by Assiut University.
Trial summary
The Study evaluates the role of low dose epinephrine boluses in management of acute hypo-tension VS The Traditional management of acute hypo-tension. Half of the participants suffering from acute hypo-tension will receive low dose epinephrine boluses (≤ 5 µg/kg/dose) and the other half will receive traditional… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Hypotension and Shock
- What is being tested?
- Epinephrine and Traditional management of shock
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 1 Sep 2021
- Phase
- Interventional
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients experiencing acute hypotensive episodes whether brief or during or after medical or surgical procedures
Who cannot join
- Patients experiencing acute hypotensive episodes in arrest or pre-arrest situations
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Low Dose Epinephrine Boluses For Acute Hypotension in The Pediatrics ICU
The Study evaluates the role of low dose epinephrine boluses in management of acute hypo-tension VS The Traditional management of acute hypo-tension.
Half of the participants suffering from acute hypo-tension will receive low dose epinephrine boluses (≤ 5 µg/kg/dose) and the other half will receive traditional management of shock
Read the detailed description
Epinephrine, due to its alpha-1 and beta-adrenergic effects, is considered an important part of the management of children with hypo-tension. Epinephrine is typically used as a continuous infusion (0.02-0.5 μg/kg/min) for severe sustained hypo-tension and as a bolus (0.01 mg/kg, maximum dose = 1 mg) for bradycardia, asystole, or pulse-less arrest. There are, however, clinical conditions that may benefit from smaller doses of bolus epinephrine. For example, brief periods of hypo-tension during medical procedures, intermittent hemodynamic instability, and augmentation of low blood pressure in a pre-arrest condition. While a resuscitation (or code) dose of epinephrine would be inappropriate (as it would cause an unacceptable large increase in blood pressure and heart rate [HR]), a smaller dose may be particularly useful.
Low-dose bolus vasopressors have been used for decades by anaesthesiologists to prevent post-re-perfusion injury after solid organ transplant, control cerebral oxygenation during anaesthesia and manage acute hypo-tension during spinal surgery. Recently, use of bolus dose phenyl-ephrine has been described in the emergency department setting to augment blood pressure during periods of hypo-tension surrounding intubation. Finally, free open access medical publications have provided some insight into using bolus dose pressors for acute hypotensive episodes in adults. However, there is few published data describing the use of low-dose vasopressor boluses in children.
- Conditions
- Hypotension and Shock
- Being tested
- Epinephrine, Traditional management of shock
- Medical subject headings
- Hypotension, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinephrineDrug
Also called Adrenaline
IV Low dose Boluses
Traditional management of shockDrug
Also called Traditional management of hypotension
- Initial resuscitation: Push boluses of 20 cc/kg isotonic saline or colloid up to and over 60 cc/kg until perfusion improves or unless rales or hepatomegaly develop
- Fluid refractory shock: Begin inotrope IV/IO. Use atropine/ketamine IV/IO/IM to obtain central access and airway if needed. Reverse cold shock by titrating central dopamine or, if resistant, titrate central epinephrine. Reverse warm shock by titrating central norepinephrine.
- Catecholamine resistant shock: Begin hydrocortisone if at risk for absolute adrenal insufficiency.
| Study group | Role | What they receive |
|---|---|---|
| Low dose Epinephrine boluses | Active comparator | Patients suffering from acute hypo-tension will receive low dose IV epinephrine boluses ≤ 5 μg/kg/dose, 3 doses, within 3 hours Receives: Drug: Epinephrine |
| Traditional management of shock | Placebo comparator | Patients suffering from acute hypo-tension will be managed according to Traditional algorithm of Hypotension Receives: Drug: Traditional management of shock |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of mean value of blood Pressure both systolic and diastolic according to age group
Assessment of patients' blood Pressure (both systolic and diastolic) will be at at the onset of acute hypo-tension and after every bolus of low dose epinephrine and pressure will be reassessed after 20 minutes from each bolus
Measured: within 1 Hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypotension and ShockStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed E Eldaly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671070
- Sponsor's protocol ID
- RLDEBAH
- Status last verified
- Sep 2018
- First submitted
- 7 Sep 2018
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reiter PD, Roth J, Wathen B, LaVelle J, Ridall LA. Low-Dose Epinephrine Boluses for Acute Hypotension in the PICU. Pediatr Crit Care Med. 2018 Apr;19(4):281-286. doi: 10.1097/PCC.0000000000001448.
PubMed 29319635
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Low Dose Epinephrine Boluses For Acute Hypotension in The Pediatrics ICU
- ClinicalTrials.gov ID
- NCT03671070
- Acronym / sponsor ID
- RLDEBAH
- Conditions
- Hypotension and Shock
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 14 Sep 2018 (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.
The Study evaluates the role of low dose epinephrine boluses in management of acute hypo-tension VS The Traditional management of acute hypo-tension.
Half of the participants suffering from acute hypo-tension will receive low dose epinephrine boluses (≤ 5 µg/kg/dose) and the other half will receive traditional management of shock
Detailed description
Epinephrine, due to its alpha-1 and beta-adrenergic effects, is considered an important part of the management of children with hypo-tension. Epinephrine is typically used as a continuous infusion (0.02-0.5 μg/kg/min) for severe sustained hypo-tension and as a bolus (0.01 mg/kg, maximum dose = 1 mg) for bradycardia, asystole, or pulse-less arrest. There are, however, clinical conditions that may benefit from smaller doses of bolus epinephrine. For example, brief periods of hypo-tension during medical procedures, intermittent hemodynamic instability, and augmentation of low blood pressure in a pre-arrest condition. While a resuscitation (or code) dose of epinephrine would be inappropriate (as it would cause an unacceptable large increase in blood pressure and heart rate [HR]), a smaller dose may be particularly useful.
Low-dose bolus vasopressors have been used for decades by anaesthesiologists to prevent post-re-perfusion injury after solid organ transplant, control cerebral oxygenation during anaesthesia and manage acute hypo-tension during spinal surgery. Recently, use of bolus dose phenyl-ephrine has been described in the emergency department setting to augment blood pressure during periods of hypo-tension surrounding intubation. Finally, free open access medical publications have provided some insight into using bolus dose pressors for acute hypotensive episodes in adults. However, there is few published data describing the use of low-dose vasopressor boluses in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose Epinephrine boluses | Active comparator | Drug: EpinephrinePatients suffering from acute hypo-tension will receive low dose IV epinephrine boluses ≤ 5 μg/kg/dose, 3 doses, within 3 hours |
| Traditional management of shock | Placebo comparator | Drug: Traditional management of shockPatients suffering from acute hypo-tension will be managed according to Traditional algorithm of Hypotension |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients experiencing acute hypotensive episodes whether brief or during or after medical or surgical procedures
Key exclusion criteria (1 listed)
- Patients experiencing acute hypotensive episodes in arrest or pre-arrest situations
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 |
|---|---|---|
| EpinephrineAlso: AdrenalineIV Low dose Boluses | Drug | Low dose Epinephrine boluses |
| Traditional management of shockAlso: Traditional management of hypotension1. Initial resuscitation: Push boluses of 20 cc/kg isotonic saline or colloid up to and over 60 cc/kg until perfusion improves or unless rales or hepatomegaly develop 2. Fluid refractory shock: Begin inotrope IV/IO. Use atropine/ketamine IV/IO/IM to obtain central access and airway if needed. Reverse cold shock by titrating central dopamine or, if resistant, titrate central epinephrine. Reverse warm shock by titrating central norepinephrine. 3. Catecholamine resistant shock: Begin hydrocortisone if at risk for absolute adrenal insufficiency. | Drug | Traditional management of shock |
Primary outcome
change of mean value of blood Pressure both systolic and diastolic according to age group
Time frame: within 1 Hours after injection
Assessment of patients' blood Pressure (both systolic and diastolic) will be at at the onset of acute hypo-tension and after every bolus of low dose epinephrine and pressure will be reassessed after 20 minutes from each bolus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
- Results publication: PubMed 29319635Reiter PD, Roth J, Wathen B, LaVelle J, Ridall LA. Low-Dose Epinephrine Boluses for Acute Hypotension in the PICU. Pediatr Crit Care Med. 2018 Apr;19(4):281-286. doi: 10.1097/PCC.0000000000001448.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Epinephrine and Traditional management of shock in people with Hypotension and Shock, run by Assiut University.
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 1 inclusion and 1 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 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Maher M Ahmed, Professer (+201062052802, maher61ahmed@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of mean value of blood Pressure both systolic and diastolic according to age group (time frame: within 1 Hours after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03671070, which also lists 1 linked publication.
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 14 Sep 2018.