The Pharmacokinetics of Fentanyl in Intensive Care Patients

NCT02587273 | Unknown Phase 4 DMC

• 2 other identifiers: FENTANYL06. Version 82006-000885-35
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study is part of a project intended to develop guidelines to optimise the dosing of fentanyl in intensive care patients. This study will focus on determining:

• Whether the pharmacokinetics of fentanyl change during the ICU stay.
• To what extent / the degree of change in fentanyl pharmacokinetics in ICU patients.
• Which factors (e.g. physiological variables) that cause such a change.
• Based on simulations, determine context-sensitive half-times of fentanyl in ICU patients.

Conditions

Multiple Organ Failure; Critical Care; Intensive Care

Keywords

Critical care; Intensive Care; Fentanyl; Pharmacokinetics; Multiple Organ Failure

Outcome Measures

Primary Outcomes (1)

• Concentration versus time of fentanyl in plasma

  Randomly collected time points within a time block of 7 consecutive time points post stop in daily fentanyl administration. Time blocks: Block1:0, 2,15, 45,120, 240, 360 min. Block2: 0, 4, 20, 60, 150, 270, 360 min. Block3: 0, 8, 25, 75, 180, 300, 360 min. Block4: 0, 10, 30, 90, 210, 330, 360 min.

  Daily samples during a time frame of 360 min. as long as the participant needs artificial ventilation and fentanyl.

Secondary Outcomes (5)

• Concentrations of fentanyl and norfentanyl in urine

  1 daily sample as long as the participant needs artificial ventilation and are treated with fentanyl.

• Concentration versus time of fentanyl in plasma from sample pre-dialysis filter line

  Daily samples during a time frame of 360 min. as long as the participant receives CVVH, artificial ventilation and fentanyl.

• Concentration versus time of fentanyl in plasma from sample at post-dialysis filter line

  Daily samples during a time frame of 360 min. as long as the participant receives CVVH, artificial ventilation and fentanyl.

• Concentration of fentanyl in dialysate

  1 daily sample from dialysate in 10 participants receiving CVVH, artificial ventilation and are treated with fentanyl.

• Concentration versus time of norfentanyl in plasma

  Daily samples during a time frame of 360 min. as long as the participant needs artificial ventilation and fentanyl.

Study Arms (1)

Fentanyl

OTHER

This is a pharmacokinetics study with a single arm. All participants will will undergo the intervention described under the intervention section

Drug: Fentanyl

Interventions

Fentanyl DRUG

In this study there will be no administration of an investigational product per study protocol. The dosage of fentanyl will be according to the ICU's established procedures and the treating physician's judgment. The specific dose of fentanyl given to each patient will differ extensively. By routine, the ICU's in our hospital usually dose the fentanyl infusion as 0,5 - 6 μg/kg/hrs (kg = Ideal Body Weight). The intervention in this study will be a per protocol cessation in administration of fentanyl over a 6 hours period. Arterial blood samples, urine samples, pre and post filter samples and samples from dialysate will be collected during this 6 hours. If the patient needs opioid analgesia during the period, alternative opioid analgesia will be given.

Also known as: Fentanyl Citrate

Fentanyl

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive patients admitted to the ICU at Oslo University Hospital - Ullevål, in whom mechanical ventilation for \> 72 hrs. is expected
• Aged 18 - 80 years, both inclusive
• Serum beta-HCG negative if female of childbearing potential, aged 18 - 45 years (both inclusive)

You may not qualify if:

• Tracheally intubated \> 12 hrs. before admittance to the ICU
• Known hypersensitivity to fentanyl or other opioids
• Post partum \< 6 weeks and/or lactating
• Informed consent not received
• Any reason why, in the opinion of the investigator and/or the treating physicians, the patient should not participate in the study

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of California: collaborator

Study Sites (1)

Oslo University Hospital, Ullevål

Oslo, Oslo County, 0424, Norway

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Multiple Organ Failure

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tom Heier, Professor

  Dept. of Anaesthesia, Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lill-Kristin K Kjaervik, MD

CONTACT

45223523; lilkje@gmail.com

Tom Heier, Professor

CONTACT

922338520; tom.heier@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: October 27, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 29, 2015

Record last verified: 2015-10

Locations

NO (1)