Factors Associated With Decisions to Withhold or Withdraw Intensive Care

Sponsor
Uppsala University (Other)
Overall Status
Completed
CT.gov ID
NCT05394961
Collaborator
(none)
33,256
1

Study Details

Study Description

Brief Summary

Medical and socioeconomic data are extracted from the Swedish Intensive Care Registry (SIR), the Swedish National Patient Registry and Statistics Sweden for all adult patients admitted to in Swedish intensive care units between 2014-01-01 and 2020-12-31 with a diagnosis of sepsis and/or acute respiratory distress syndrome (ARDS) and/or coronavirus 19 (COVID-19) infection, and registered in SIR. The impact of demographic and socioeconomic factors on decisions to withhold or withdraw intensive care, and on mortality, are studied and statistically adjusted for level of chronic comorbidity and severity of acute illness.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Treatment in an intensive care unit with a diagnosis of sepsis and/or ARDS and/or covid-19

Detailed Description

Patient identification and data acquisition With permission from the ethical board of Sweden, all registered intensive care episodes with a diagnosis of sepsis, acute respiratory distress syndrome (ARDS) or coronavirus 19 (COVID-19) and admission between 2014-01-01 and 2020-12-31 are identified in the Swedish Intensive Care Registry (SIR). Basic demographic data (age, sex) and intensive care data from SIR are combined with comorbidity data from the National Patient Registry of the Board of Health and Welfare (Socialstyrelsen), and data on country of birth, household size, education and economy from Statistics Sweden (SCB) to produce a pseudonymized study data set. For patients with multiple intensive care episodes, the first one is used.

Analysis Descriptive data on the frequency of decisions to withhold or withdraw intensive care, and on demographic and socioeconomic factors, morbidity and mortality in patients with or without such decisions, are produced. Logistic regression is used to assess the association between demographic and socioeconomic factors and limitations in intensive care, adjusting for acute and chronic morbidity and accounting for multicenter data. Secondarily, association between the same factors and mortality is studied.

Study Design

Study Type:
Observational
Actual Enrollment :
33256 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Are Socioeconomic Factors, Sex and Country of Birth Associated With Decisions to Withhold or Withdraw Intensive Care in Swedish Hospitals?
Actual Study Start Date :
Aug 26, 2021
Actual Primary Completion Date :
Aug 26, 2021
Actual Study Completion Date :
Aug 26, 2021

Outcome Measures

Primary Outcome Measures

  1. Decision to withhold or withdraw intensive care [During ICU care]

    Registered decision

Secondary Outcome Measures

  1. 30 day mortality [30 days]

    death within 30 days of ICU admission

  2. 90 day mortality [90 days]

    death within 90 days of ICU admission

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Registered intensive care episode with relevant diagnosis
Exclusion Criteria:
  • None, if inclusion criteria fulfilled

Contacts and Locations

Locations

Site City State Country Postal Code
1 Uppsala University, department of Surgical Sciences Uppsala Sweden 75185

Sponsors and Collaborators

  • Uppsala University

Investigators

  • Principal Investigator: Miklós Lipcsey, MD, PhD, Upsala University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Uppsala University
ClinicalTrials.gov Identifier:
NCT05394961
Other Study ID Numbers:
  • Uppsala University
First Posted:
May 27, 2022
Last Update Posted:
May 27, 2022
Last Verified:
May 1, 2022
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
Keywords provided by Uppsala University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 27, 2022