The Short and Long-term Cardiovascular Consequences of Critical Illness: The C3 Study

Sponsor
University of Oxford (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04545437
Collaborator
(none)
80,000
1
35.7
2242.2

Study Details

Study Description

Brief Summary

The aim this study will be to find out which patients are at risk of heart attacks/strokes up to several years after discharge from an ICU. This study will also investigate whether treatments and events occurring in ICU contribute to this risk.

Condition or Disease Intervention/Treatment Phase
  • Other: Admission to ICU

Detailed Description

Undertake a retrospective observational cohort study of patients admitted to intensive care units between 2006 and 2023.

Study Participants: Adult patients admitted to a general adult intensive care unit at one or more of the study sites between 2006 and 1st of August 2023.

Objectives:

To determine the short and long-term cardiovascular consequences of critical illness and identify in-ICU factors that affect them.

To identify the risk factors for new-onset atrial fibrillation/flutter occurring during critical illness.

To study the association between poor cardiovascular function during critical illness and long-term cardiovascular disease.

This study will provide new knowledge about the associations between baseline cardiovascular risk, the disease resulting in ICU admission and therapies / events on ICU with subsequent major adverse cardiac events (MACE), to allow the ongoing risk of these events to be determined. If clinicans can idetnify who is at risk, then risk factors can potentially be modified .

Study Design

Study Type:
Observational
Anticipated Enrollment :
80000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Short and Long-term Cardiovascular Consequences of Critical Illness: The C3 Study
Actual Study Start Date :
Aug 10, 2020
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
ICU

Patients treated on a general adult intensive care unit

Other: Admission to ICU
Exposure is admission to an Intensive Care Unit

Outcome Measures

Primary Outcome Measures

  1. Mortality [5 years]

  2. Major adverse cardiovascular and vascular events [5 years]

  3. Arrhythmia [5 years]

Secondary Outcome Measures

  1. Hospital re-admission [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Aged 16 years or above.

  • Admitted to an intensive care unit at a study site from 2006 onwards

Exclusion Criteria:
  • Patients that have informed their participating site that they do not wish their electronic records would be used for future research

  • Patients who inform us directly that they don't wish their records used in this research study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kadoorie Centre Oxford Oxfordshire United Kingdom OX3 9DU

Sponsors and Collaborators

  • University of Oxford

Investigators

  • Study Director: Peter Watkinson, University of Oxford

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University of Oxford
ClinicalTrials.gov Identifier:
NCT04545437
Other Study ID Numbers:
  • PID14762
  • Oxford Rec C
  • Confidentiality Advisory Group
First Posted:
Sep 11, 2020
Last Update Posted:
Sep 29, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2021