Factors Associated With Decisions to Withhold or Withdraw Intensive Care

COVID-19 Clinical Trial

Official title:

Are Socioeconomic Factors, Sex and Country of Birth Associated With Decisions to Withhold or Withdraw Intensive Care in Swedish Hospitals?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05394961
• Other study ID #: Uppsala University
• Status: Completed
• Start date: August 26, 2021
• Est. completion date: August 26, 2021

Study information

• Verified date: May 2022
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33256
• Est. completion date: August 26, 2021
• Est. primary completion date: August 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Registered intensive care episode with relevant diagnosis

Exclusion Criteria:

• None, if inclusion criteria fulfilled

Related Conditions & MeSH terms

• ARDS, Human
• COVID-19
• Respiratory Distress Syndrome
• Sepsis

Intervention

Procedure:
• Treatment in an intensive care unit with a diagnosis of sepsis and/or ARDS and/or covid-19
As above

Locations

Country	Name	City	State
Sweden	Uppsala University, department of Surgical Sciences	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decision to withhold or withdraw intensive care	Registered decision	During ICU care
Secondary	30 day mortality	death within 30 days of ICU admission	30 days
Secondary	90 day mortality	death within 90 days of ICU admission	90 days