Sepsis Pathophysiological & Organisational Timing

NCT01099813 | Completed DMC

• 1 other identifier: SPOT-Light
• Study Type: observational
• Target: 15,602
• Locations: 1 country
• Sites: 1

Brief Summary

This project proposes to measure delay to admission to Intensive Care (ICU). Delays in the United Kingdom NHS are widely reported possibly because there are fewer ICU beds than in many other developed health care systems. Patients are inevitably admitted with more severe illness. Scores measuring this severity are used for research and benchmarking. However, although patients deteriorate over time, severity is probably neither directly nor linearly related to the duration of illness. Instead it is likely that the characteristics of severity change with time. In sepsis there is good biological evidence of this so that there is an early pro-inflammatory stage followed by later changes in metabolic, neuroendocrine, and immune systems. In addition to examining the effect of duration of illness prior to ICU admission, the investigators will also therefore investigate how severity changes over time. SPOT(Light) is a prospective observational study. Treatment is not modified in anyway. Patients evaluated on the ward by critical care outreach teams, and subsequently admitted to critical care will be eligible. Severity of illness at the time of initial evaluation and eventual admission will be compared, and the effect of the duration of illness on 90 day survival investigated.

Conditions

Critical Illness; Sepsis

Keywords

Critical Illness; Sepsis; Duration; Severity of Illness Scores; Trajectory

Outcome Measures

Primary Outcomes (1)

• Survival

  90 day

Study Arms (1)

Inpatients assessed for critical care

Patients admitted to Critical Care Units participating in the ICNARC CMP programme who have been assessed at any time on a ward prior to ICU admission by a critical care decision maker (e.g. the CCOT or any member of the medical staff on duty for the unit)

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

Patients admitted to Critical Care Units participating in the ICNARC CMP programme who have been assessed at any time on a ward prior to ICU admission by a critical care decision maker (e.g. the CCOT or any member of the medical staff on duty for the unit)

You may not qualify if:

• Paediatric patients (Age \< 18 years)
• Elective or planned admissions to critical care

Sponsors & Collaborators

• Intensive Care National Audit & Research Centre: lead
• Wellcome Trust: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (1)

University College Hospital London

London, London, NW1 2BU, United Kingdom

Location

Related Links

• Intensive Care National Audit \& Research Centre

MeSH Terms

Conditions

Critical Illness; Sepsis

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Steve Harris, MRCP FRCA

  ICNARC / LSHTM

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 7, 2010
• First Posted: April 8, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 23, 2014

Record last verified: 2014-05

Locations

GB (1)