Pharmacokinetic Analysis of Midazolam and Fentanyl in Ped... | NCT02302391

Studies
Pharmacokinetic Analysis of Midazolam and Fentanyl in Pediatric Patients With Long-term Analgosedation

NCT02302391

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Status

Completed

Last Update Posted

Apr 30, 2021Actual

Enrollment

25Actual

Phase

Not provided

Conditions

Deep Sedation
Intensive Care Pediatric

Interventions

PK analysis

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014Actual

Primary Completion Date

Mar 2018Actual

Completion Date

Oct 2018Actual

First Submitted Date

Nov 24, 2014

First Submission Date that Met QC Criteria

Nov 26, 2014

First Posted Date

Nov 27, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2021

Last Update Posted Date

Apr 30, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Dr.med. Dominique Singer, Head of Section Neonatology and Pediatric Intensive Care, University Medical Center Hamburg-Eppendorf, Universitätsklinikum Hamburg-EppendorfPrincipal Investigator

Lead Sponsor

Universitätsklinikum Hamburg-EppendorfOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Midazolam/fentanyl: PK analysis		Pediatric intensive care patients under analgosedation with midazolam and fentanyl.	Other: PK analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PK analysis	Other	Quantification of Serum Levels and subsequent pharmacokinetic (PK) modelling.	Midazolam/fentanyl: PK analysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma levels of midazolam, 1'-Hydroxymidazolam and fentanyl and resulting pharmacokinetic parameters		Once daily during analgosedation [expected average of 10 days) and 0, 1, 2, and 4h after stopping of midazolam

Secondary Outcomes

Measure	Description	Time Frame
Duration of mechanical ventilation		Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days
Sedation depth		Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pediatric patients between 28 days and 17 years of age
mechanical ventilation more than 3 days
analgosedation with midazolam and fentanyl

Exclusion Criteria:

missing informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

28 Days

Maximum Age

17 Years

Standard Ages

Child

Study Population

Pediatric patients with long-term analgosedation at the Pediatric Intensive Care Unit of the University Medical Center Hamburg-Eppendorf.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dominique Singer, Prof. Dr.	University Medical Center Hamburg-Eppendorf, Department of Pediatrics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Hamburg-Eppendorf		Hamburg		20246	Germany