Critical IllnessCIOSNCT01109719
Critical Illness Outcomes Study
An observational study of Critical Illness and Intensive Care, run by National Institute of General Medical Sciences (NIGMS) at 1 site in United States.
Trial summary
We will test whether the way that an intensive care unit is organized can influence patient related outcomes such as mortality. We will test whether who works in the ICU, and how the ICU is managed will affect the care received by patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Intensive Care, Intensive Care Unit
- How many people
- 6,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Apr 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients present in study ICU's on the days of enrollement
Who may be able to join
- Hospitalized adult patient in a study ICU on the date of data collection. This includes patients who may be in ICU despite not having critical illness for reasons such as lack of floor beds.
Who cannot join
- -
- 1. Patient enrolled on previous study collection day 2 Previous enrollment into other study ICU 3. Age < 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: The Association of ICU Organization and Structure on in Patient Mortality
We will test whether the way that an intensive care unit is organized can influence patient related outcomes such as mortality. We will test whether who works in the ICU, and how the ICU is managed will affect the care received by patients. The primary study hypothesis is whether the number of clinical protocols present in an intensive care unit is linked to patient mortality
Read the detailed description
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.
- Compliance with disease specific protocols is not independently associated with hospital survival for critically ill patients
Specific Aims
- 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
Study Design
- 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.
- Conditions
- Critical Illness, Intensive Care, Intensive Care Unit
- Keywords
- Protocol, Critical pathway, Intensive care units
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
In Patient Mortality
Measured: Hospital discharge or 60 days
Secondary outcomes (3)
2. Mortality prior to ICU discharge 3. Length of ICU stay 4. Length of hospital stay ICU mortality
Measured: ICU discharge or 60 days
ICU length of stay
Measured: ICU discharge or 60 days
Length of hospital stay
Measured: Hospital discharge or 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startJul 2010
- Primary completionFeb 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jonathan Sevransky, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109719
- Sponsor's protocol ID
- CIITG-2
- Other IDs
- K23GM071399
- Acronym
- CIOS
- Status last verified
- Aug 2010
- First submitted
- 22 Apr 2010
- Last updated
- 25 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Umoh NJ, Fan E, Mendez-Tellez PA, Sevransky JE, Dennison CR, Shanholtz C, Pronovost PJ, Needham DM. Patient and intensive care unit organizational factors associated with low tidal volume ventilation in acute lung injury. Crit Care Med. 2008 May;36(5):1463-8. doi: 10.1097/CCM.0b013e31816fc3d0.
PubMed 18434907Levy MM, Rapoport J, Lemeshow S, Chalfin DB, Phillips G, Danis M. Association between critical care physician management and patient mortality in the intensive care unit. Ann Intern Med. 2008 Jun 3;148(11):801-9. doi: 10.7326/0003-4819-148-11-200806030-00002.
PubMed 18519926Pronovost PJ, Angus DC, Dorman T, Robinson KA, Dremsizov TT, Young TL. Physician staffing patterns and clinical outcomes in critically ill patients: a systematic review. JAMA. 2002 Nov 6;288(17):2151-62. doi: 10.1001/jama.288.17.2151.
PubMed 12413375Pronovost P, Needham D, Berenholtz S, Sinopoli D, Chu H, Cosgrove S, Sexton B, Hyzy R, Welsh R, Roth G, Bander J, Kepros J, Goeschel C. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006 Dec 28;355(26):2725-32. doi: 10.1056/NEJMoa061115.
PubMed 17192537Ali NA, Gutteridge D, Shahul S, Checkley W, Sevransky J, Martin GS. Critical Illness Outcome Study: An Observational Study on Protocols and Mortality in Intensive Care Units. Open Access J Clin Trials. 2011 Sep 23;2011(3):55-65. doi: 10.2147/OAJCT.S24223.
PubMed 25429244
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of ICU Organization and Structure on in Patient Mortality
- ClinicalTrials.gov ID
- NCT01109719
- Acronym / sponsor ID
- CIOS / CIITG-2
- Conditions
- Critical Illness, Intensive Care, Intensive Care Unit
- Keywords
- Protocol, Critical pathway, Intensive care units
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)US National Institutes of Health
- Study start
- Jul 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 23 Apr 2010 (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.
We will test whether the way that an intensive care unit is organized can influence patient related outcomes such as mortality. We will test whether who works in the ICU, and how the ICU is managed will affect the care received by patients. The primary study hypothesis is whether the number of clinical protocols present in an intensive care unit is linked to patient mortality
Detailed description
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.
- Compliance with disease specific protocols is not independently associated with hospital survival for critically ill patients
Specific Aims
- 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
Study Design
- 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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients present in study ICU's on the days of enrollement
Key inclusion criteria (1 listed)
- Hospitalized adult patient in a study ICU on the date of data collection. This includes patients who may be in ICU despite not having critical illness for reasons such as lack of floor beds.
Key exclusion criteria (2 listed)
- -
- 1. Patient enrolled on previous study collection day 2 Previous enrollment into other study ICU 3. Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In Patient Mortality
Time frame: Hospital discharge or 60 days
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2010.
- Background: PubMed 18434907Umoh NJ, Fan E, Mendez-Tellez PA, Sevransky JE, Dennison CR, Shanholtz C, Pronovost PJ, Needham DM. Patient and intensive care unit organizational factors associated with low tidal volume ventilation in acute lung injury. Crit Care Med. 2008 May;36(5):1463-8. doi: 10.1097/CCM.0b013e31816fc3d0.
- Background: PubMed 18519926Levy MM, Rapoport J, Lemeshow S, Chalfin DB, Phillips G, Danis M. Association between critical care physician management and patient mortality in the intensive care unit. Ann Intern Med. 2008 Jun 3;148(11):801-9. doi: 10.7326/0003-4819-148-11-200806030-00002.
- Background: PubMed 12413375Pronovost PJ, Angus DC, Dorman T, Robinson KA, Dremsizov TT, Young TL. Physician staffing patterns and clinical outcomes in critically ill patients: a systematic review. JAMA. 2002 Nov 6;288(17):2151-62. doi: 10.1001/jama.288.17.2151.
- Background: PubMed 17192537Pronovost P, Needham D, Berenholtz S, Sinopoli D, Chu H, Cosgrove S, Sexton B, Hyzy R, Welsh R, Roth G, Bander J, Kepros J, Goeschel C. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006 Dec 28;355(26):2725-32. doi: 10.1056/NEJMoa061115.
- Derived from this study: PubMed 25429244Ali NA, Gutteridge D, Shahul S, Checkley W, Sevransky J, Martin GS. Critical Illness Outcome Study: An Observational Study on Protocols and Mortality in Intensive Care Units. Open Access J Clin Trials. 2011 Sep 23;2011(3):55-65. doi: 10.2147/OAJCT.S24223.
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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.
Jonathan Sevransky, MD, MHS principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Intensive Care, run by National Institute of General Medical Sciences (NIGMS) at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 25 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
In Patient Mortality (time frame: Hospital discharge or 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01109719, which also lists 5 linked publications.
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 25 Aug 2010.