NCT02556476

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

September 18, 2015

Last Update Submit

September 21, 2015

Conditions

Keywords

critical careintensive carehealth related quality of lifecost benefit analysis

Outcome Measures

Primary Outcomes (1)

  • survival

    mortality was recorded one year after hospital discharge and subtracted from the value od 100% in order to get one year survival

    one year after hospital release

Secondary Outcomes (2)

  • mortality

    30 days and 60 days after critical illness onset and one year after hospital release

  • health related quality of life (HRQOL)

    one year after hospital release

Study Arms (1)

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 ventilationProcedure: neuromuscular blockadeProcedure: renal replacement therapyProcedure: non-invasive ventilation

Interventions

ventilator support for the patients presenting with acute respiratory failure

Also known as: ventilator
ICU patients

paralysis of the skeletal muscles in order to optimize mechanical ventilation, especially during ARDS

Also known as: neuromuscular block
ICU patients

the procedures used to treat acute kidney injury

Also known as: continuous hemofiltration (CHF) or hemodiafiltration (CHDF)
ICU patients

Procedure used for ventilation support in patients with congestive heart failure, pulmonary edema, COPD and some other conditions.

Also known as: continuous positive airway pressure (CPAP)
ICU patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

consecutive critically ill patients treated during one year in a recently established medical ICU at the Sarajevo University Clinical Center.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Critical Illness

Interventions

Respiration, ArtificialVentilators, MechanicalNeuromuscular BlockadeRenal Replacement TherapyHemodiafiltrationNoninvasive VentilationContinuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory TherapyEquipment and SuppliesAnesthesia and AnalgesiaInvestigative TechniquesRenal DialysisSorption DetoxificationHemofiltrationExtracorporeal CirculationSurgical Procedures, OperativePositive-Pressure Respiration

Study Officials

  • Hajrunisa Cubro, MD

    Medical ICU University of Sarajevo Clinical Center, Sarajevo, Bosnia and Herzegovina

    PRINCIPAL INVESTIGATOR
  • Ognjen Gajic, MD, MSc

    Division of Pulmonary and Critical Care Mayo Clinic Rochester MN USA

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 18, 2015

First Posted

September 22, 2015

Study Start

June 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2013

Last Updated

September 22, 2015

Record last verified: 2015-09