NCT07582601

Brief Summary

The goal of this observational study is to understand the genetic and molecular risk factors for developing critical illness in adult intensive care unit (ICU) patients in Sweden. The main questions it aims to answer are: Which genetic variants are associated with increased risk of critical illness from conditions such as infections, sepsis, and organ failure? Can circulating proteins and metabolites mediate the effect of genetic risk factors on the severity of illness? Participants will: Provide blood samples at ICU admission and again 3-6 months after discharge Consent to genetic analysis and data linkage with national health registries Have their ICU treatment and outcomes followed using registry and clinical data This study aims to build a national infrastructure for rapid sample collection and analysis that can also support research in future pandemics.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25,000

participants targeted

Target at P75+ for all trials

Timeline
110mo left

Started Jan 2027

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2035

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2035

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

9 years

First QC Date

November 24, 2025

Last Update Submit

May 11, 2026

Conditions

Keywords

critical illnessshocksepsisheart failureardsacute kidney injuryinfectionorgan failureintensive care

Outcome Measures

Primary Outcomes (2)

  • 30 day mortality

    Death of any cause within 30 days of ICU admission

    30 days

  • ICU admission

    ICU admission for any specific cause

    30 days

Study Arms (1)

ICU admission

Any patient admitted to ICU in Sweden

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient admitted to intensive care at a hospital in Sweden

You may qualify if:

  • Adults admitted to intensive care in Sweden

You may not qualify if:

  • Non adults
  • Not admitted to intensive care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and plasma

MeSH Terms

Conditions

Critical IllnessShockSepsisHeart FailureAcute Lung InjuryAcute Kidney InjuryInfections

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSystemic Inflammatory Response SyndromeInflammationHeart DiseasesCardiovascular DiseasesLung InjuryLung DiseasesRespiratory Tract DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Michael Marks-Hultström, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 24, 2025

First Posted

May 13, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 30, 2035

Study Completion (Estimated)

December 30, 2035

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Swedish legal requirements preclude sharing individual patient data. Patient data access for collaborators is provided on a secure system.