Critical Illness Outcomes Study

NCT01109719 | Unknown

• 2 other identifiers: CIITG-2K23GM071399
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief 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. The primary study hypothesis is whether the number of clinical protocols present in an intensive care unit is linked to patient mortality

Conditions

Critical Illness; Intensive Care; Intensive Care Unit

Keywords

Protocol; Critical pathway; Intensive care units

Outcome Measures

Primary Outcomes (1)

• In Patient Mortality

  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

  ICU discharge or 60 days

• ICU length of stay

  ICU discharge or 60 days

• Length of hospital stay

  Hospital discharge or 60 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients present in study ICU's on the days of enrollement

You may qualify if:

• \- 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.

You may not qualify if:

• \. Patient enrolled on previous study collection day 2 Previous enrollment into other study ICU 3. Age \< 18 years

Sponsors & Collaborators

• National Institute of General Medical Sciences (NIGMS): lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (5)

• 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.

  PMID: 18434907 BACKGROUND

• Levy 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.

  PMID: 18519926 BACKGROUND

• Pronovost 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.

  PMID: 12413375 BACKGROUND

• Pronovost 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.

  PMID: 17192537 BACKGROUND

• Ali 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.

  PMID: 25429244 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Sevransky, MD, MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: April 23, 2010
• Study Start: July 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: April 1, 2011
• Last Updated: August 25, 2010

Record last verified: 2010-08

Locations

US (1)