Critical IllnessCEACCLRNCT02556476
Cost Effectiveness Analysis of Critical Care in Resource Limited Setting
An observational study of Critical Illness, run by University of Sarajevo.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness
- What is being tested?
- mechanical ventilation, neuromuscular blockade and renal replacement therapy
- Type of treatment
- Surgery or procedure
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: consecutive critically ill patients treated during one year in a recently established medical ICU at the Sarajevo University Clinical Center.
Who may be able to join
- patients treated between June 1 2011 and June 29 2012 in the medical ICU
Who cannot join
- Patients who stayed in the ICU less than 24 hours and
- hospital readmissions
About this study
Official title: Cost Effectiveness of Intensive Care in a Low Resource Setting: Prospective Cohort of Medical Critically Ill Patients
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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- mechanical ventilation, neuromuscular blockade, renal replacement therapy, non-invasive ventilation
- Keywords
- critical care, intensive care, health related quality of life, cost benefit analysis
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical ventilationProcedure or surgery
Also called ventilator
ventilator support for the patients presenting with acute respiratory failure
neuromuscular blockadeProcedure or surgery
Also called neuromuscular block
paralysis of the skeletal muscles in order to optimize mechanical ventilation, especially during ARDS
renal replacement therapyProcedure or surgery
Also called continuous hemofiltration (CHF) or hemodiafiltration (CHDF)
the procedures used to treat acute kidney injury
non-invasive ventilationProcedure or surgery
Also called continuous positive airway pressure (CPAP)
Procedure used for ventilation support in patients with congestive heart failure, pulmonary edema, COPD and some other conditions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: mechanical ventilation; Procedure: neuromuscular blockade; Procedure: renal replacement therapy; Procedure: non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
mortality was recorded one year after hospital discharge and subtracted from the value od 100% in order to get one year survival
Measured: one year after hospital release
Secondary outcomes (2)
mortality
Measured: 30 days and 60 days after critical illness onset and one year after hospital release
health related quality of life (HRQOL)
HRQOL was assessed using EQ5D-3L questionnaire
Measured: one year after hospital release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sarajevo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajrunisa Cubro, University of Sarajevo
- Investigators
- Hajrunisa Cubro, MD, Principal investigator, Medical ICU University of Sarajevo Clinical Center, Sarajevo, Bosnia and HerzegovinaOgnjen Gajic, MD, MSc, Study chair, Division of Pulmonary and Critical Care Mayo Clinic Rochester MN USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556476
- Sponsor's protocol ID
- CCUS-2435/11
- Acronym
- CEACCLR
- Status last verified
- Sep 2015
- First submitted
- 18 Sep 2015
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Effectiveness of Intensive Care in a Low Resource Setting: Prospective Cohort of Medical Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02556476
- Acronym / sponsor ID
- CEACCLR / CCUS-2435/11
- Conditions
- Critical Illness
- Keywords
- critical care, intensive care, health related quality of life, cost benefit analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of SarajevoUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | Procedure: mechanical ventilation, Procedure: neuromuscular blockade, Procedure: renal replacement therapy, Procedure: non-invasive ventilationThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- consecutive critically ill patients treated during one year in a recently established medical ICU at the Sarajevo University Clinical Center.
Key inclusion criteria (1 listed)
- patients treated between June 1 2011 and June 29 2012 in the medical ICU
Key exclusion criteria (2 listed)
- Patients who stayed in the ICU less than 24 hours and
- hospital readmissions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mechanical ventilationAlso: ventilatorventilator support for the patients presenting with acute respiratory failure | Procedure or surgery | ICU patients |
| neuromuscular blockadeAlso: neuromuscular blockparalysis of the skeletal muscles in order to optimize mechanical ventilation, especially during ARDS | Procedure or surgery | ICU patients |
| renal replacement therapyAlso: continuous hemofiltration (CHF) or hemodiafiltration (CHDF)the procedures used to treat acute kidney injury | Procedure or surgery | ICU patients |
| non-invasive ventilationAlso: continuous positive airway pressure (CPAP)Procedure used for ventilation support in patients with congestive heart failure, pulmonary edema, COPD and some other conditions. | Procedure or surgery | ICU patients |
Primary outcome
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
2 secondary outcomes
mortality
Time frame: 30 days and 60 days after critical illness onset and one year after hospital release
health related quality of life (HRQOL)
Time frame: one year after hospital release
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hajrunisa Cubro, MD principal investigator
Medical ICU University of Sarajevo Clinical Center, Sarajevo, Bosnia and Herzegovina
Ognjen Gajic, MD, MSc study chair
Division of Pulmonary and Critical Care Mayo Clinic Rochester MN USA
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by University of Sarajevo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival (time frame: one year after hospital release). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2015.