Clincosm LogoSign in Get a demo

INTOx: Blood Serum Concentrations of Routine Drugs in Patients Treated in the Intensive Care Unit.

Sponsor
Uppsala University (Other)
Overall Status
Completed
CT.gov ID
NCT02305004
Collaborator
Forensic Toxicology Laboratory, Sweden (Other)
359
Enrollment
1
Location
39
Actual Duration (Months)
9.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To follow up the result of a quality measurement based on the results of a new routine for drug analysis introduced during a period of time in the intensive care unit. To ensure the quality of the dose regimen of routine drugs for sedation and analgesics. The aim is also to find out if the routine analysis can give information about if the self- intoxicated patients have taken drugs that were primarily not suspected.To know the serum concentrations of routine drugs in patients who died and will undergo autopsy.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients treated in the intensive care unit (ICU) are treated with a variety of sedative and analgesic drugs to be able to undergo intensive care. The amount of drugs that each patient receives is based on standard dosages where the dose regimen is based on clinical studies with a limited number of patients included. Most patients treated in the intensive care unit have a varying degree of cardiac, renal or liver failure which affects the metabolism of the drugs administered. Possibly, the drug concentrations achieved with the standard dosages administered to these patients can vary significantly between patients. This may possibly lead to an extended stay at the ICU which gives the patient an unnecessary suffering, affects the patient's family and increases the cost of health care.

    Intoxications due to suicidal purposes is common and usually results in intensive care for those who survive. It is often unknown what type of medication or drugs these patients have been taken and what serum concentration it may result in. Screening methods are available but the information it gives us today may not be enough for the initial acute care of the patient. Also, there are no previous studies with reliable documentation regarding the drug concentrations in the blood of patents that die in the intensive care unit. It is also unknown what kind of drugs and amount of doses given before the death of these patients. It is of significant importance to increase the knowledge in this area to be able to evaluate if the medicines administered before death of patients in intensive care could affect the outcome.

    Blood samples will be taken according to routine procedures upon the patients arrival at the ICU and then 2 times per day.

    The drug analysis includes drugs used for sedation and analgesia. These samples will be analysed at the national board of forensic medicine (Rättsmedicinalverket) in Linköping. There will also be a screening of unknown or suspected drugs taken by self- intoxicated patients. Sedation ratio by the Richmond agitation sedation scale (RASS) will be evaluated and recorded 3 times per day. An assessment of the visual analogy scale (VAS) will be done for the patients who are awake and are able to cooperate. All physiological measurements will be measured and documented according to local routines. For patients who die at the ICU and undergo autopsy, blood samples will be taken after death for analysis of routine drugs.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    359 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    INTOx A Prospective Measurement of Serum Concentrations of Routine Drugs in Patients Treated in the Intensive Care Unit-A Quality Measurement/Improvement for Clinical Treatment and Forensic Assessment
    Actual Study Start Date :
    Sep 1, 2013
    Actual Primary Completion Date :
    Dec 1, 2016
    Actual Study Completion Date :
    Dec 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Drug serum concentrations inhospital patients at ICU and after death [1-2 years]

      Drug serum concentrations of sedative and analgesics in relation to the quantity of drugs administered and in relation to routine assessment scales of sedation and estimated pain.

    Secondary Outcome Measures

    1. Concentrations in relation to organ failure. [1-2 years]

      Drug serum concentration in relation to organ failure.

    2. self intoxicated patients [1-2 years]

      Drug serum concentration in self intoxicated patients in relation to possibly known intake of drugs.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    All patients except for children under the age of 7 treated in the Central intensive care unit at Uppsala university hospital, Uppsala Sweden.

    Exclusion Criteria:

    Age < 7 years old.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uppsala University hospital Uppsala Sweden 75185

    Sponsors and Collaborators

    • Uppsala University
    • Forensic Toxicology Laboratory, Sweden

    Investigators

    • Principal Investigator: Sten Rubertsson, MdPhd, Uppsala University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Uppsala University
    ClinicalTrials.gov Identifier:
    NCT02305004
    Other Study ID Numbers:
    • INT001
    First Posted:
    Dec 2, 2014
    Last Update Posted:
    Apr 17, 2018
    Last Verified:
    Apr 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Apr 17, 2018