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The Pharmacokinetics of Fentanyl in Intensive Care Patients (FENTANYL06)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02587273
Recruitment Status : Unknown
Verified October 2015 by Oslo University Hospital.
Recruitment status was:  Recruiting
First Posted : October 27, 2015
Last Update Posted : October 29, 2015
Sponsor:
Collaborator:
University of California
Information provided by (Responsible Party):
Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Multiple Organ Failure Critical Care Intensive Care Drug: Fentanyl Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Pharmacokinetics of Fentanyl in Intensive Care Patients
Study Start Date : October 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Fentanyl
This is a pharmacokinetics study with a single arm. All participants will will undergo the intervention described under the intervention section
Drug: Fentanyl
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.
Other Name: Fentanyl Citrate




Primary Outcome Measures :
  1. Concentration versus time of fentanyl in plasma [ Time Frame: Daily samples during a time frame of 360 min. as long as the participant needs artificial ventilation and fentanyl. ]
    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.


Secondary Outcome Measures :
  1. Concentrations of fentanyl and norfentanyl in urine [ Time Frame: 1 daily sample as long as the participant needs artificial ventilation and are treated with fentanyl. ]
    Daily Sample from urine collected over 0 - 360 min. post stop in fentanyl administration.

  2. Concentration versus time of fentanyl in plasma from sample pre-dialysis filter line [ Time Frame: Daily samples during a time frame of 360 min. as long as the participant receives CVVH, artificial ventilation and fentanyl. ]
    Samples are collected at the same timepoints as the samples from the arterial line described in outcome 1.

  3. Concentration versus time of fentanyl in plasma from sample at post-dialysis filter line [ Time Frame: Daily samples during a time frame of 360 min. as long as the participant receives CVVH, artificial ventilation and fentanyl. ]
    Samples are collected at the same timepoints as the samples from the arterial line described in outcome 1.

  4. Concentration of fentanyl in dialysate [ Time Frame: 1 daily sample from dialysate in 10 participants receiving CVVH, artificial ventilation and are treated with fentanyl. ]
    Sample from dialysate collected over 0 - 360 min. post stop in fentanyl administration.

  5. Concentration versus time of norfentanyl in plasma [ Time Frame: Daily samples during a time frame of 360 min. as long as the participant needs artificial ventilation and fentanyl. ]
    Samples are collected in time blocks from the arterial line described in outcome 1.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587273


Contacts
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Contact: Lill-Kristin K Kjaervik, MD 45223523 lilkje@gmail.com
Contact: Tom Heier, Professor 922338520 tom.heier@medisin.uio.no

Locations
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Norway
Oslo University Hospital, Ullevål Recruiting
Oslo, Norway, 0424
Contact: Lill-Kristin K Kjaervik, MD    45223523    lilkje@gmail.com   
Contact: Tom Heier, Professor    92238520    tom.heier@medisin.uio.no   
Principal Investigator: Tom Heier, Professor         
Sub-Investigator: Lill-Kristin K Kjaervik, MD         
Sub-Investigator: Johan Raeder, Professor         
Sub-Investigator: Kjetil Sunde, Professor         
Sponsors and Collaborators
Oslo University Hospital
University of California
Investigators
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Principal Investigator: Tom Heier, Professor Dept. of Anaesthesia, Oslo University Hospital

Publications:
Fukuda K. Intravenous opioid anesthetics. In Anesthesia, 6th Ed (ed Miller RD), Elsevier Churchill Livingstone, Philadelphia, pp 379-437

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Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02587273    
Other Study ID Numbers: FENTANYL06. Version 8
2006-000885-35 ( EudraCT Number )
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015
Keywords provided by Oslo University Hospital:
Critical care
Intensive Care
Fentanyl
Pharmacokinetics
Multiple Organ Failure
Additional relevant MeSH terms:
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Multiple Organ Failure
Shock
Pathologic Processes
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics