Factors Associated With Decisions to Withhold or Withdraw Intensive Care

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Sepsis; ARDS, Human
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 33256

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 75185
    • Uppsala University, department of Surgical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population consists of an absolute majority of the patients treated in Swedish intensive care units with the relevant diagnoses during the study period and can therefore be considered a nationwide population rather than a sample thereof.

Description

Inclusion Criteria:

• Registered intensive care episode with relevant diagnosis

Exclusion Criteria:

• None, if inclusion criteria fulfilled

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision to withhold or withdraw intensive care	Registered decision	During ICU care

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 day mortality	death within 30 days of ICU admission	30 days
90 day mortality	death within 90 days of ICU admission	90 days

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Miklós Lipcsey, MD, PhD, Upsala University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 26, 2021
• Primary Completion (ACTUAL): August 26, 2021
• Study Completion (ACTUAL): August 26, 2021

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (ACTUAL): May 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: intensive care unit; critical care; critical illness; limitations of care
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Distress Syndrome
• Other Study ID Numbers: Uppsala University (Uppsala Ethical Review board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data are used with special permission from the national ethical bord of Sweden (Etikprövningsmyndigheten) and the involved register keepers and so cannot be shared without an extended permission.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No