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

NCT02305004 | Completed

• 1 other identifier: INT001
• Study Type: observational
• Target: 359
• Locations: 1 country
• Sites: 1

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.

Conditions

Serum Concentrations; Intoxication; Post Mortem Concentrations

Outcome Measures

Primary Outcomes (1)

• 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.

  1-2 years

Secondary Outcomes (2)

• Concentrations in relation to organ failure.

  1-2 years

• self intoxicated patients

  1-2 years

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• Age \< 7 years old.

Sponsors & Collaborators

• Uppsala University: lead
• Forensic Toxicology Laboratory, Sweden: collaborator

Study Sites (1)

Uppsala University hospital

Uppsala, 75185, Sweden

Location

Study Officials

• Sten Rubertsson, MdPhd

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2014
• First Posted: December 2, 2014
• Study Start: September 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 17, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)