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Cost Effectiveness Analysis of Critical Care in Resource Limited Setting (CEACCLR)

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ClinicalTrials.gov Identifier: NCT02556476
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : September 22, 2015
Sponsor:
Information provided by (Responsible Party):
Hajrunisa Cubro, University of Sarajevo

Brief Summary:

The purpose of this study was to examine the cost effectiveness of critical care in a middle income country with limited resources.

The main study hypothesis was that critical care is cost effective in low resources setting.


Condition or disease Intervention/treatment
Critical Illness Procedure: mechanical ventilation Procedure: neuromuscular blockade Procedure: renal replacement therapy Procedure: non-invasive ventilation

Detailed Description:

The investigators objective was to calculate the cost effectiveness of treatment of critically ill patients in a medical ICU of a middle income country with limited access to ICU resources.

Methods: Consecutive critically ill medical patients treated in a recently established medical ICU in Sarajevo, Bosnia and Herzegovina, were prospectively recorded and a subsequent cost utility analysis of intensive care in comparison to hospital ward treatment from the perspective of health care system was performed. Incremental cost effectiveness was calculated using estimates of ICU versus non-ICU treatment effectiveness based on a formal systematic review of published studies. Decision analytic modeling was used to compare treatment alternatives. Sensitivity analyses of the key model parameters were performed.

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Study Type : Observational
Actual Enrollment : 148 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cost Effectiveness of Intensive Care in a Low Resource Setting: Prospective Cohort of Medical Critically Ill Patients
Study Start Date : June 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care

Group/Cohort Intervention/treatment
ICU patients
The actual cohort of 148 critically ill medical patients that received the treatment in the intensive care unit (ICU). The interventions include interventions that are usually performed within the ICU such as mechanical ventilation, non-invasive ventilation, neuromuscular blockade, renal replacement therapy.
Procedure: mechanical ventilation
ventilator support for the patients presenting with acute respiratory failure
Other Name: ventilator

Procedure: neuromuscular blockade
paralysis of the skeletal muscles in order to optimize mechanical ventilation, especially during ARDS
Other Name: neuromuscular block

Procedure: renal replacement therapy
the procedures used to treat acute kidney injury
Other Name: continuous hemofiltration (CHF) or hemodiafiltration (CHDF)

Procedure: non-invasive ventilation
Procedure used for ventilation support in patients with congestive heart failure, pulmonary edema, COPD and some other conditions.
Other Name: continuous positive airway pressure (CPAP)




Primary Outcome Measures :
  1. survival [ Time Frame: one year after hospital release ]
    mortality was recorded one year after hospital discharge and subtracted from the value od 100% in order to get one year survival


Secondary Outcome Measures :
  1. mortality [ Time Frame: 30 days and 60 days after critical illness onset and one year after hospital release ]
  2. health related quality of life (HRQOL) [ Time Frame: one year after hospital release ]
    HRQOL was assessed using EQ5D-3L questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
consecutive critically ill patients treated during one year in a recently established medical ICU at the Sarajevo University Clinical Center.
Criteria

Inclusion Criteria:

  • patients treated between June 1 2011 and June 29 2012 in the medical ICU

Exclusion Criteria:

  • Patients who stayed in the ICU less than 24 hours and
  • hospital readmissions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556476


Sponsors and Collaborators
University of Sarajevo
Investigators
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Principal Investigator: Hajrunisa Cubro, MD Medical ICU University of Sarajevo Clinical Center, Sarajevo, Bosnia and Herzegovina
Study Chair: Ognjen Gajic, MD, MSc Division of Pulmonary and Critical Care Mayo Clinic Rochester MN USA
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Responsible Party: Hajrunisa Cubro, MD, University of Sarajevo
ClinicalTrials.gov Identifier: NCT02556476    
Other Study ID Numbers: CCUS-2435/11
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015
Keywords provided by Hajrunisa Cubro, University of Sarajevo:
critical care
intensive care
health related quality of life
cost benefit analysis
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes