Clinical trial NCT05394961: Factors Associated With Decisions to Withhold or Withdraw Intensive Care
Official title: Are Socioeconomic Factors, Sex and Country of Birth Associated With Decisions to Withhold or Withdraw Intensive Care in Swedish Hospitals?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
ARDS, Human
COVID-19
Keywords: critical care
limitations of care
critical illness
intensive care unit
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 33256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Registered intensive care episode with relevant diagnosis

Exclusion Criteria:

* None, if inclusion criteria fulfilled

Primary outcomes:
measure: Decision to withhold or withdraw intensive care
timeFrame: During ICU care
Secondary outcomes:
measure: 30 day mortality
timeFrame: 30 days
measure: 90 day mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University, department of Surgical Sciences
Study officials:
affiliation: Upsala University
name: Miklós Lipcsey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: