Deep SedationMorpheusNCT02302391
Pharmacokinetic Analysis of Midazolam and Fentanyl in Pediatric Patients With Long-term Analgosedation
An observational study of Deep Sedation and Intensive Care Pediatric, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Pharmacokinetic monitoring of midazolam, it's active metabolite and fentanyl in pediatric patients with long-term analgosedation will be performed. Especially, the chronologic sequence of the quantified plasma levels during sedation and during wake-up as well as the correlation to dose and sedation depth will be… Read more about this study
- Who is it for?
- Ages 28 days to 17 years
- Conditions the study is for
- Deep Sedation, Intensive Care Pediatric
- What is being tested?
- PK analysis
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Oct 2018
- 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 28 days to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients with long-term analgosedation at the Pediatric Intensive Care Unit of the University Medical Center Hamburg-Eppendorf.
Who may be able to join
- pediatric patients between 28 days and 17 years of age
- mechanical ventilation more than 3 days
- analgosedation with midazolam and fentanyl
Who cannot join
- missing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Analysis of Midazolam and Fentanyl in Pediatric Patients With Long-term Analgosedation.
Pharmacokinetic monitoring of midazolam, it's active metabolite and fentanyl in pediatric patients with long-term analgosedation will be performed. Especially, the chronologic sequence of the quantified plasma levels during sedation and during wake-up as well as the correlation to dose and sedation depth will be focused.
Read the detailed description
At pre-defined timepoints (see below) serum Levels of the above mentioned drugs and metabolites will be determined and pharmakokinetic (PK) modeling will be performed. PK data will be correlated to sedation depth, as assessed using a validated score.
Three Age Groups (infants, children and adolescents) will be evaluated considering the physiologic properties during pediatric development.
- Conditions
- Deep Sedation, Intensive Care Pediatric
- Being tested
- PK analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PK analysisOther
Quantification of Serum Levels and subsequent pharmacokinetic (PK) modelling.
| Study group | Role | What they receive |
|---|---|---|
| Midazolam/fentanyl: PK analysis | Pediatric intensive care patients under analgosedation with midazolam and fentanyl. Receives: Other: PK analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of midazolam, 1'-Hydroxymidazolam and fentanyl and resulting pharmacokinetic parameters
Measured: Once daily during analgosedation [expected average of 10 days) and 0, 1, 2, and 4h after stopping of midazolam
Secondary outcomes (3)
Duration of mechanical ventilation
Measured: Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days
Sedation depth
Measured: Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days
Length of stay at the intensive care unit (ICU)
Measured: Participants will be followed for the duration of stay at the ICU, an expected average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep SedationStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr.med. Dominique Singer, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Dominique Singer, Prof. Dr., Principal investigator, University Medical Center Hamburg-Eppendorf, Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302391
- Sponsor's protocol ID
- PV4546
- Acronym
- Morpheus
- Status last verified
- Apr 2021
- First submitted
- 24 Nov 2014
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Analysis of Midazolam and Fentanyl in Pediatric Patients With Long-term Analgosedation.
- ClinicalTrials.gov ID
- NCT02302391
- Acronym / sponsor ID
- Morpheus / PV4546
- Conditions
- Deep Sedation, Intensive Care Pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 27 Nov 2014 (estimated)
- 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.
Pharmacokinetic monitoring of midazolam, it's active metabolite and fentanyl in pediatric patients with long-term analgosedation will be performed. Especially, the chronologic sequence of the quantified plasma levels during sedation and during wake-up as well as the correlation to dose and sedation depth will be focused.
Detailed description
At pre-defined timepoints (see below) serum Levels of the above mentioned drugs and metabolites will be determined and pharmakokinetic (PK) modeling will be performed. PK data will be correlated to sedation depth, as assessed using a validated score.
Three Age Groups (infants, children and adolescents) will be evaluated considering the physiologic properties during pediatric development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Midazolam/fentanyl: PK analysis | – | Other: PK analysisPediatric intensive care patients under analgosedation with midazolam and fentanyl. |
Who may qualify
- Ages
- 28 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients with long-term analgosedation at the Pediatric Intensive Care Unit of the University Medical Center Hamburg-Eppendorf.
Key inclusion criteria (3 listed)
- pediatric patients between 28 days and 17 years of age
- mechanical ventilation more than 3 days
- analgosedation with midazolam and fentanyl
Key exclusion criteria (1 listed)
- missing informed consent
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 |
|---|---|---|
| PK analysisQuantification of Serum Levels and subsequent pharmacokinetic (PK) modelling. | Other | Midazolam/fentanyl: PK analysis |
Primary outcome
Plasma levels of midazolam, 1'-Hydroxymidazolam and fentanyl and resulting pharmacokinetic parameters
Time frame: Once daily during analgosedation [expected average of 10 days) and 0, 1, 2, and 4h after stopping of midazolam
3 secondary outcomes
Duration of mechanical ventilation
Time frame: Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days
Sedation depth
Time frame: Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days
Length of stay at the intensive care unit (ICU)
Time frame: Participants will be followed for the duration of stay at the ICU, an expected average of 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
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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.
Dominique Singer, Prof. Dr. principal investigator
University Medical Center Hamburg-Eppendorf, Department of Pediatrics
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 Deep Sedation and Intensive Care Pediatric, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 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: finished, as of the sponsor's last update on 30 Apr 2021. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma levels of midazolam, 1'-Hydroxymidazolam and fentanyl and resulting pharmacokinetic parameters (time frame: Once daily during analgosedation [expected average of 10 days) and 0, 1, 2, and 4h after stopping of midazolam). 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 30 Apr 2021.