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5 Years Mortality-rate in Patients Treated for Severe Pneumonia in an ICU - a Retrospective Study (pneumonia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02212093
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : July 23, 2015
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Vegard Dahl, University Hospital, Akershus

Tracking Information
First Submitted Date August 7, 2014
First Posted Date August 8, 2014
Last Update Posted Date July 23, 2015
Study Start Date June 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 7, 2014)
5 years mortality [ Time Frame: 5 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02212093 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 7, 2014)
cause of death after discharge from the hospital [ Time Frame: 5 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 5 Years Mortality-rate in Patients Treated for Severe Pneumonia in an ICU - a Retrospective Study
Official Title Cause-specific 5 Years Mortality-rate in Patients Treated for Severe Pneumonia in an ICU - a Retrospective Study
Brief Summary Severe pneumonia has a high in-hospital mortality. There are few studies which investigate the long-term mortality in patients that are discharged alive from the hospital. In this study we want to investigate the 5 years mortality after treatment of severe pneumonia in an ICU. We will also investigate the cause of death after discharge from the hospital.
Detailed Description

Patients with severe pneumonia who need treatment in an ICU have a high in-hospital mortality (16-46%). There are few studies which investigate the long-term mortality (> 1year) in patients after discharge from the hospital. There seems to be a higher mortality in this group compared to the general population. The cause(s) of this higher long-term mortality is unclear and few studies have investigated this problem.

We are going to investigate the 5 years mortality rate in this population of patients. We are also going to investigate the cause of death in the patients who are discharged from the hospital alive.

Inclusion criteria: Patients > 18 years. Primary diagnose: pneumonia, and the need of mechanical ventilation for at least 24 hours in an ICU. The patients who arrive at the ICU in Akershus University Hospital in the period from 01.01.1997 to 31.12.2006.

The datas are collected from the patients' journals and the local ICU register. Collecting data: Age, sex, comorbidity, SAPSII, mechanical ventilation time, stay in the ICU, stay in the hospital, ICU mortality, hospital mortality, 5 years mortality, type of pneumonia (bacteriology).

Time of death after discharge is collected from Norwegian National Registry. Cause of death after discharge is collected from Norwegian Institute of Public Health.

Study Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Bacteriology tests
Sampling Method Non-Probability Sample
Study Population The same as the inclusion criteria
Condition Pneumonia
Intervention Not Provided
Study Groups/Cohorts pneumonia and mechanical ventilation
The data are collected retrospectively from this one group.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 22, 2015)
236
Original Estimated Enrollment
 (submitted: August 7, 2014)
250
Actual Study Completion Date February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients > 18 years. Primary diagnose: pneumonia, and the need of mechanical ventilation for at least 24 hours in an ICU. The patients who arrived the ICU in Akershus University Hospital in the period from 01.01.1997 to 31.12.2006.

Exclusion Criteria:

  • Patients < 18 years. Patients with need for mechanical ventilation < 24 hours
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT02212093
Other Study ID Numbers 2013/2338
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Vegard Dahl, University Hospital, Akershus
Study Sponsor University Hospital, Akershus
Collaborators Oslo University Hospital
Investigators
Principal Investigator: Vegard Dahl, Professor University Hospital, Akershus
PRS Account University Hospital, Akershus
Verification Date July 2015