Status AsthmaticusPhase 3NCT03338205
The Role of Ketamine as an Adjuvant Therapy for Children With Acute Status Asthmaticus
A Phase 3 study testing Ketamine in people with Status Asthmaticus, run by Augusta University.
Trial summary
The purpose of this investigation is to perform a pilot study assessing the safety and utility of intravenous ketamine as an adjuvant therapy in the emergency department setting for pediatric patients in acute status asthmaticus who have failed standard emergency therapy. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Status Asthmaticus
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Jan 2022
- Phase
- Phase 3
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients (≥2 years and ≤ 18 years old)
- Patients presenting in status asthmaticus:
- Patients with a CAS of greater than or equal to 10 on presentation that have received at least two (appropriately dosed based on weight) albuterol treatments prior to arrival
- OR
- Patients with a CAS of greater than or equal to 10 that have not received treatment prior to arrival and after 1 hour of treatment per the severe asthma pathway do not have a decrease in CAS of greater than 2
- OR
- Patients with a CAS above 6 but less than 10 as measured 1 hour after initiation of standard treatment per AU's moderate asthma pathway
Who cannot join
- Pregnancy
- Congestive Heart Failure or prior diagnosis of cardiovascular disease (congenital or acquired)
- Chronic lung disease outside of a previous diagnosis of Asthma
- Seizure disorder
- Liver disease
- History of hypertension greater than 95% for age
Show all 9Show fewer
- Obstructive Sleep Apnea with AHI greater than 5
- History of allergic or serious reaction to Ketamine
- Significant history of psychiatric illness defined as any patient with a diagnosis of psychiatric illness meeting the Diagnostic and Statistical Manual of Mental Disorders V criteria (severe Autism)
About this study
Official title: The Role of Ketamine as an Adjuvant Therapy for Children With Acute Status Asthmaticus in Pediatric Emergency Medicine Patients: A Pilot Study
The purpose of this investigation is to perform a pilot study assessing the safety and utility of intravenous ketamine as an adjuvant therapy in the emergency department setting for pediatric patients in acute status asthmaticus who have failed standard emergency therapy.
Read the detailed description
This is a pilot study of a cohort of 20 subjects to assess the feasibility, safety and efficacy of ketamine in status asthmaticus.
The study will take place at the Augusta University's pediatric emergency department 24 hours a day. The attending physician who is clinically treating the patient will identify the patient as a potential study candidate (see inclusion criteria). Study team members will then be notified and obtain informed consent for potential participants who meet the inclusion/exclusion criteria.
Once a patient in the Augusta University Children's Hospital of Georgia Pediatric Emergency Department is deemed a potential study subject, informed consent will be obtained by the research study team members. The patient and their parents will be provided with all the required information about the study including potential risks and benefits associated with participation. The information will be presented in a private setting in a language the patient understands. The patient and/or their parent/guardian will have opportunities to ask questions and will be given enough time to consider participation before providing consent. A document will be given to obtain assent/consent that reiterates all the information about the study (including reason for the study, risks, benefits, etc.)
Study team members that will be actively involved in the study will be either pediatric emergency medicine faculty or pediatric emergency medicine fellows that are on staff.
Patients that meet the inclusion and exclusion criteria will have ketamine 1 mg/kg IV bolus administered once informed consent has been obtained.
- Conditions
- Status Asthmaticus
- Being tested
- Ketamine
- Keywords
- ketamine, pediatric status asthmaticus
- Medical subject headings
- Status Asthmaticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
1 mg/kg ketamine bolus IV
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Treatment | Experimental | Everyone enrolled in study presenting in status asthmaticus to pediatric emergency department at Augusta University will receive a ketamine treatment, who include:
* Patients with a Clinical Asthma SCore (CAS) of greater than or equal to 10 on presentation and have received at least two (appropriately dosed based on weight) albuterol treatments prior to arrival
OR
* Patients with a CAS of ≥ greater than or equal to 10 that have not received treatment prior to arrival and after receiving 1 hour of treatment per the severe asthma pathway do not have a decrease in CAS of greater than 2
OR
* Patients with a CAS above > 6 but less than < 10 when as measured 1 hour after initiation of standard treatment per Augusta University's moderate asthma pathway Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of ketamine in status asthmaticus by assessing change in clinical asthma score (CAS)
CAS will be documented on admission, prior to intervention, 30 minutes and 60 minutes after administration of ketamine. The CAS is a scoring system to assess the severity of asthma used by Augusta University and is based on physiological measurements and clinical appearance.
Measured: prior to intervention, 30 minutes and 60 minutes after administration of ketamine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study startJan 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJan 2022 (estimated)
Why it stopped: Unable to enroll patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status AsthmaticusStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338205
- Sponsor's protocol ID
- 51152
- Status last verified
- Feb 2024
- First submitted
- 1 Nov 2017
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Ketamine as an Adjuvant Therapy for Children With Acute Status Asthmaticus in Pediatric Emergency Medicine Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT03338205
- Acronym / sponsor ID
- 51152
- Conditions
- Status Asthmaticus
- Keywords
- ketamine, pediatric status asthmaticus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 9 Nov 2017 (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 purpose of this investigation is to perform a pilot study assessing the safety and utility of intravenous ketamine as an adjuvant therapy in the emergency department setting for pediatric patients in acute status asthmaticus who have failed standard emergency therapy.
Detailed description
This is a pilot study of a cohort of 20 subjects to assess the feasibility, safety and efficacy of ketamine in status asthmaticus.
The study will take place at the Augusta University's pediatric emergency department 24 hours a day. The attending physician who is clinically treating the patient will identify the patient as a potential study candidate (see inclusion criteria). Study team members will then be notified and obtain informed consent for potential participants who meet the inclusion/exclusion criteria.
Once a patient in the Augusta University Children's Hospital of Georgia Pediatric Emergency Department is deemed a potential study subject, informed consent will be obtained by the research study team members. The patient and their parents will be provided with all the required information about the study including potential risks and benefits associated with participation. The information will be presented in a private setting in a language the patient understands. The patient and/or their parent/guardian will have opportunities to ask questions and will be given enough time to consider participation before providing consent. A document will be given to obtain assent/consent that reiterates all the information about the study (including reason for the study, risks, benefits, etc.)
Study team members that will be actively involved in the study will be either pediatric emergency medicine faculty or pediatric emergency medicine fellows that are on staff.
Patients that meet the inclusion and exclusion criteria will have ketamine 1 mg/kg IV bolus administered once informed consent has been obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Ketamine Treatment | Experimental | Drug: KetamineEveryone enrolled in study presenting in status asthmaticus to pediatric emergency department at Augusta University will receive a ketamine treatment, who include: * Patients with a Clinical Asthma SCore (CAS) of greater than or equal to 10 on presentation and have received at least two (appropriately dosed based on weight) albuterol treatments prior to arrival OR * Patients with a CAS of ≥ greater than or equal to 10 that have not received treatment prior to arrival and after receiving 1 hour of treatment per the severe asthma pathway do not have a decrease in CAS of greater than 2 OR * Patients with a CAS above > 6 but less than < 10 when as measured 1 hour after initiation of standard treatment per Augusta University's moderate asthma pathway |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Pediatric patients (≥2 years and ≤ 18 years old)
- Patients with a CAS of greater than or equal to 10 on presentation that have received at least two (appropriately dosed based on weight) albuterol treatments prior to arrival
- OR
- Patients with a CAS of greater than or equal to 10 that have not received treatment prior to arrival and after 1 hour of treatment per the severe asthma pathway do not have a decrease in CAS of greater than 2
- OR
Key exclusion criteria (9 listed)
- Pregnancy
- Congestive Heart Failure or prior diagnosis of cardiovascular disease (congenital or acquired)
- Chronic lung disease outside of a previous diagnosis of Asthma
- Seizure disorder
- Liver disease
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 |
|---|---|---|
| Ketamine1 mg/kg ketamine bolus IV | Drug | Ketamine Treatment |
Primary outcome
Efficacy of ketamine in status asthmaticus by assessing change in clinical asthma score (CAS)
Time frame: prior to intervention, 30 minutes and 60 minutes after administration of ketamine
CAS will be documented on admission, prior to intervention, 30 minutes and 60 minutes after administration of ketamine. The CAS is a scoring system to assess the severity of asthma used by Augusta University and is based on physiological measurements and clinical appearance.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine in people with Status Asthmaticus, run by Augusta 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 7 inclusion and 9 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: withdrawn, as of the sponsor's last update on 6 Feb 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of ketamine in status asthmaticus by assessing change in clinical asthma score (CAS) (time frame: prior to intervention, 30 minutes and 60 minutes after administration of ketamine). 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 6 Feb 2024.