NCT05860504

Brief Summary

The overall aim of the study is to establish the clinical importance of cardiac dysfunction, by estimating its incidence and impact on short- and long-term outcomes, in a mixed population of critically ill patients with multi-organ failure. Pathogenesis of cardiac dysfunction in critical illness and key molecules linked to this will be explored.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
592

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
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

May 8, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

May 29, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

2.6 years

First QC Date

May 8, 2023

Last Update Submit

October 3, 2023

Conditions

Multi Organ FailureLeft Ventricular DysfunctionRight Ventricular DysfunctionTako Tsubo CardiomyopathyMyocardial InfarctionCardiomyopathy, Stress

Outcome Measures

Primary Outcomes (1)

  • 90-days mortality

    Death

    90 days

Secondary Outcomes (3)

  • Alive outside ICU

    90 days

  • Alive without mechanical ventilation

    90 days

  • Alive without CRRT

    90 days

Study Arms (2)

Normal left ventricular systolic function

Patients with normal echocardiographic systolic function, defined as having left ventricular ejection fraction ≥ 50% and no regional hypokinesia

Diagnostic Test: Echocardiography

Left ventricular dysfunction

Patients with echocardiographic left ventricular systolic dysfunction, defines as having left ventricular ejection fraction \< 50% or left ventricular regional hypokinesia in at least two adjacent segments

Diagnostic Test: EchocardiographyDiagnostic Test: Cardiac magnetic resonance imagingDiagnostic Test: Coronary CT

Interventions

EchocardiographyDIAGNOSTIC_TEST

All patients in the study will be examined with echocardiography

Left ventricular dysfunctionNormal left ventricular systolic function
Cardiac magnetic resonance imagingDIAGNOSTIC_TEST

Sub-group of patients with left ventricular systolic dysfunction will be examined with cMRI

Also known as: cMRI
Left ventricular dysfunction
Coronary CTDIAGNOSTIC_TEST

Sub-group of patients with left ventricular systolic dysfunction will be examined with CCT

Also known as: CCT
Left ventricular dysfunction

Eligibility Criteria

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

Patients with significant multi-organ dysfunction being admitted to a participaing ICU within 24 hours

You may qualify if:

  • Patients aged \> 18 years
  • Admitted to a participating ICU within 24 hours
  • Significant organ dysfunction involving at least two organ systems. This is defined as fulfilling both of the following:
  • At least 4 points on the SOFA scale (Sequential Organ Failure Assessment scale)
  • Having at least 1 point on the SOFA scale from at least two organ systems
  • Given informed consent from patient or permission to participate from next of kin

You may not qualify if:

  • Echocardiographic examination not possible (e.g., pneumothorax, draping etc) or very low echocardiographic examination quality
  • Retracted consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahgrensak University Hospital

Västra Frölunda, Please Select, 42668, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Multiple Organ FailureVentricular Dysfunction, LeftVentricular Dysfunction, RightTakotsubo CardiomyopathyMyocardial Infarction

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

ShockPathologic ProcessesPathological Conditions, Signs and SymptomsVentricular DysfunctionHeart DiseasesCardiovascular DiseasesCardiomyopathiesMyocardial IschemiaVascular DiseasesInfarctionIschemiaNecrosis

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Central Study Contacts

Jonatan Oras, MD, PhD

CONTACT

+46313421000jonatan.oras@vgregion.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor/Senior consultant

Study Record Dates

First Submitted

May 8, 2023

First Posted

May 16, 2023

Study Start

May 29, 2023

Primary Completion

December 31, 2025

Study Completion

March 30, 2026

Last Updated

October 6, 2023

Record last verified: 2023-10

Locations

SE(1)