NCT02454257

Brief Summary

The aim of the proposed study is to better understand the epidemiology of, risk factors for and consequences of critical illness leading to improvements in the risk models used to underpin national clinical audits for adult general critical care, cardiothoracic critical care and in-hospital cardiac arrest using data linkage with other routinely collected data sources.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,007,147

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
6.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2022

Completed
Last Updated

January 9, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

May 20, 2015

Last Update Submit

January 6, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • All cause mortality

    30-days

  • All cause mortality

    90-days

  • All cause mortality

    1-year

Other Outcomes (4)

  • diabetes

    up to 5 year

  • end-stage renal disease

    up to 5 year

  • ROSC

    at time of reanimation

  • +1 more other outcomes

Study Arms (2)

Admission to ICU

Patients admitted to an adult critical care unit or cardiothoracic critical care unit

In-hospital cardiac arrest

Patients experiencing an in-hospital cardiac arrest

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to an adult critical care unit or cardiothoracic critical care unit or experiencing an in-hospital cardiac arrest in an NHS acute hospital in England or Wales.

You may qualify if:

  • Admission to an adult critical care unit or cardiothoracic critical care unit or in-hospital cardiac arrest

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ferrando-Vivas P, Shankar-Hari M, Thomas K, Doidge JC, Caskey FJ, Forni L, Harris S, Ostermann M, Gornik I, Holman N, Lone N, Young B, Jenkins D, Webb S, Nolan JP, Soar J, Rowan KM, Harrison DA. Improving risk prediction model quality in the critically ill: data linkage study [Internet]. Southampton (UK): National Institute for Health and Care Research; 2022 Dec. Available from http://www.ncbi.nlm.nih.gov/books/NBK587779/

Related Links

MeSH Terms

Conditions

Critical IllnessHeart Arrest

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • David Harrison, MA PhD

    Head Statistician, ICNARC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Statistician

Study Record Dates

First Submitted

May 20, 2015

First Posted

May 27, 2015

Study Start

August 1, 2015

Primary Completion

March 31, 2016

Study Completion

December 23, 2022

Last Updated

January 9, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

An anonymised study dataset will be available on request from the Chief Investigator, subject to any necessary approvals