Association Between Resuscitation Orders and Mortality in ICU Patients

NCT06373068 | Active Not Recruiting

• 1 other identifier: Resuscitation Orders ICU
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of the study is that a resuscitation order other than full code is associated with increased mortality among critically ill patients. By incorporating conventional variables associated with death such as age, sex, and Simplified Acute Physiological Score, as well as including the new Clinical Frailty Scale in a statistical model, the aim is to investigate whether there is still an increased risk of death that remains unexplained.

Conditions

Critical Illness

Keywords

Resuscitation orders

Outcome Measures

Primary Outcomes (1)

• Mortality

  Hazard ratio of death

  365 days

Study Arms (3)

Full code

Patients without any restrictions on the types of treatments available, such as cardiopulmonary resuscitation, intubation, various life support measures, surgery, etc., if indicated.

Other: Resuscitation orders

Simple Do-Not-Attempt-Resuscitation

The only treatment limitation in patient care is cardiopulmonary resuscitation in case of a cardiac arrest. All other indicated devices or treatments may still be utilized.

Other: Resuscitation orders

Do not attempt resuscitation with limited scope

The treatment limitation in patient care includes not performing cardiopulmonary resuscitation and also involve additional limitations, typically including various life support measures.

Other: Resuscitation orders

Interventions

Resuscitation orders OTHER

Resuscitation orders, commonly referred to as Code Status, communicate to the healthcare team the specific medical interventions that patients will receive while hospitalised. These orders are issued by a doctor and require confirmation by at least one other licensed medical professional

Do not attempt resuscitation with limited scope; Full code; Simple Do-Not-Attempt-Resuscitation

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients admitted to the intensive care unit during 2023 and 2024

You may qualify if:

• Admitted to ICU

You may not qualify if:

• Second or subsequent admission to ICU during the study period.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institute

Stockholm, 11883, Sweden

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Resuscitation Orders

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Resuscitation; Emergency Treatment; Therapeutics; Terminal Care; Patient Care; Health Services; Health Care Facilities Workforce and Services; Jurisprudence; Social Control, Formal; Health Care Economics and Organizations

Study Officials

• Sandra Jonmarker

  Stockholm South General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Anaesthesia and Intensive care, Ph D

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: May 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: December 1, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

SE (1)