Serum ConcentrationsINTOxNCT02305004
Blood Serum Concentrations of Routine Drugs in Patients Treated in the Intensive Care Unit.
An observational study of Serum Concentrations and Intoxication, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Serum Concentrations, Intoxication, Post Mortem Concentrations
- How many people
- 359 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2013to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients except children under the age of 7 admitted in the ICU at Uppsala University hospital within the time period of 2 years. Estimated number of patients is approximately 1000-1500 patients. The inclusion of patients undergoing autopsy will be after consent from family is obtained according to local routines. Patients undergoing forensic autopsy will also be included in compliance with current regulations. The number of patients in the autopsy group is estimated to be around 100 patients.
Who may be able to join
- All patients except for children under the age of 7 treated in the Central intensive care unit at Uppsala university hospital, Uppsala Sweden.
Who cannot join
- Age < 7 years old.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug serum concentrations inhospital patients at ICU and after death
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.
Measured: 1-2 years
Secondary outcomes (2)
Concentrations in relation to organ failure.
Drug serum concentration in relation to organ failure.
Measured: 1-2 years
self intoxicated patients
Drug serum concentration in self intoxicated patients in relation to possibly known intake of drugs.
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startSep 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serum ConcentrationsStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Forensic Toxicology Laboratory, Sweden
- Responsible party
- Sponsor
- Investigators
- Sten Rubertsson, MdPhd, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305004
- Sponsor's protocol ID
- INT001
- Acronym
- INTOx
- Status last verified
- Apr 2018
- First submitted
- 27 Nov 2014
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: This is not applicable in this study. All patients according to protocol will be described in groups.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02305004
- Acronym / sponsor ID
- INTOx / INT001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Forensic Toxicology Laboratory, Sweden
- Study start
- Sep 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients except children under the age of 7 admitted in the ICU at Uppsala University hospital within the time period of 2 years. Estimated number of patients is approximately 1000-1500 patients. The inclusion of patients undergoing autopsy will be after consent from family is obtained according to local routines. Patients undergoing forensic autopsy will also be included in compliance with current regulations. The number of patients in the autopsy group is estimated to be around 100 patients.
Key inclusion criteria (1 listed)
- All patients except for children under the age of 7 treated in the Central intensive care unit at Uppsala university hospital, Uppsala Sweden.
Key exclusion criteria (1 listed)
- Age < 7 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Drug serum concentrations inhospital patients at ICU and after death
Time frame: 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.
2 secondary outcomes
Concentrations in relation to organ failure.
Time frame: 1-2 years
self intoxicated patients
Time frame: 1-2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: No. This is not applicable in this study. All patients according to protocol will be described in groups.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sten Rubertsson, MdPhd principal investigator
Uppsala University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Serum Concentrations and Intoxication, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug serum concentrations inhospital patients at ICU and after death (time frame: 1-2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.