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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02212093
Other study ID # 2013/2338
Secondary ID
Status Completed
Phase N/A
First received August 7, 2014
Last updated July 22, 2015
Start date June 2014
Est. completion date February 2015

Study information

Verified date July 2015
Source University Hospital, Akershus
Contact n/a
Is FDA regulated No
Health authority Norway: Regional Ethics Commitee
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 236
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Norway Akershus University Hospital Nordbyhagen Akershus

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Akershus Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 5 years mortality 5 years No
Secondary cause of death after discharge from the hospital 5 years No
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