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The Pharmacokinetics of Fentanyl in Intensive Care Patients

NCT02587273 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-10-29

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of California

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Tom Heier, Professor · Dept. of Anaesthesia, Oslo University Hospital

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-09-30
Completion
2017-11-30

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02587273 on ClinicalTrials.gov