Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-03-11 @ 2:09 AM
Study NCT ID:
NCT02305004
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2014-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Serum Concentrations of Routine Drugs in Patients Treated in the Intensive Care Unit.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 359}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-12', 'studyFirstSubmitDate': '2014-11-27', 'studyFirstSubmitQcDate': '2014-11-27', 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drug serum concentrations inhospital patients at ICU and after death', 'timeFrame': '1-2 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Concentrations in relation to organ failure.', 'timeFrame': '1-2 years', 'description': 'Drug serum concentration in relation to organ failure.'}, {'measure': 'self intoxicated patients', 'timeFrame': '1-2 years', 'description': 'Drug serum concentration in self intoxicated patients in relation to possibly known intake of drugs.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Serum Concentrations', 'Intoxication', 'Post Mortem Concentrations']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nIntoxications 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.\n\nBlood samples will be taken according to routine procedures upon the patients arrival at the ICU and then 2 times per day.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients except for children under the age of 7 treated in the Central intensive care unit at Uppsala university hospital, Uppsala Sweden.\n\nExclusion Criteria:\n\nAge \\< 7 years old.'}, 'identificationModule': {'nctId': 'NCT02305004', 'acronym': 'INTOx', 'briefTitle': 'Blood Serum Concentrations of Routine Drugs in Patients Treated in the Intensive Care Unit.', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'INT001'}}, 'contactsLocationsModule': {'locations': [{'zip': '75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Sten Rubertsson, MdPhd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is not applicable in this study. All patients according to protocol will be described in groups.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Forensic Toxicology Laboratory, Sweden', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}