Critical Illness Outcomes Study (CIOS)
|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: NCT01109719|
Recruitment Status : Unknown
Verified August 2010 by National Institute of General Medical Sciences (NIGMS).
Recruitment status was: Active, not recruiting
First Posted : April 23, 2010
Last Update Posted : August 25, 2010
|Condition or disease|
|Critical Illness Intensive Care Intensive Care Unit|
Title: Do ICU Structural and Procedural Factors Influence Patient Related Outcomes: The Critical Illness Outcome Study (CIOS)
Objectives: This is an exploratory ecologic study designed to examine the organizational and structural factors present in adult intensive care units in the United States. A second objective is to determine whether these organizational and structural factors are associated with patient related outcomes. In addition, we intend to examine whether these organizational and structural issues are associated with patient treatments.
Hypotheses: (Ho) A. The number of protocols used in an ICU is inversely associated with ICU and hospital survival for critically ill patients.
B. Compliance with disease specific protocols is not independently associated with hospital survival for critically ill patients
- To describe the organizational structure of participating intensive care units
- To determine whether the number of protocols used in an intensive care unit is associated with ICU and hospital survival for critically ill patients
- To determine the frequency with which ICU's follow disease specific protocols for patients with sepsis and ALI
- Prospective ecologic study of 50-60 adult intensive care units and admitted patients
- ICU organizational and structural data will be collected for each participating ICU
- 125-200 adult patients in each intensive care unit will be enrolled. Patients within the ICU on a varying, specific day each week will be included. Demographic and treatment variables will be collected for that day on that patient. Outcome data will be collected on ICU and hospital discharge.
|Study Type :||Observational|
|Estimated Enrollment :||6000 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||The Association of ICU Organization and Structure on in Patient Mortality|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||February 2011|
|Estimated Study Completion Date :||April 2011|
- In Patient Mortality [ Time Frame: Hospital discharge or 60 days ]
- 2. Mortality prior to ICU discharge 3. Length of ICU stay 4. Length of hospital stay ICU mortality [ Time Frame: ICU discharge or 60 days ]
- ICU length of stay [ Time Frame: ICU discharge or 60 days ]
- Length of hospital stay [ Time Frame: Hospital discharge or 60 days ]
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): NCT01109719
|United States, Maryland|
|Johns Hopkins Bayview Medical Center|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Jonathan Sevransky, MD, MHS||Johns Hopkins University|