Factors Associated With Decisions to Withhold or Withdraw Intensive Care

Completed

• Conditions: ARDS, Human; COVID-19; Sepsis

• Registration Number: NCT05394961
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study Start: 2021-08-26
• Primary Completion: 2021-08-26
• Study Completion: 2021-08-26
• Status Verified: 2022-05
• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-05-23
• Last Update Submitted: 2022-05-23
• Study First Posted: 2022-05-27
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33256

Inclusion Criteria

• Registered intensive care episode with relevant diagnosis

Exclusion Criteria

• None, if inclusion criteria fulfilled

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decision to withhold or withdraw intensive care	During ICU care	Registered decision

Secondary Outcome Measures

Name	Time	Method
30 day mortality	30 days	death within 30 days of ICU admission
90 day mortality	90 days	death within 90 days of ICU admission

Trial Locations

Locations (1)

Uppsala University, department of Surgical Sciences; 🇸🇪 Uppsala, Sweden