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ASSESSment of Perfusion, Oxygen Saturation, Endothelial Function and Coagulation in Circulatory SHOCK

NCT03814564 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 325

Last updated 2024-03-21

No results posted yet for this study

Summary

The objective of the observational cohort study is (1) to deduce whether measurements of peripheral near-infrared spectroscopy (NIRS) (lower limb) associate with the development of organ dysfunction as assessed by daily Sequential Orfgan Failure Score (SOFA) in the Intensive Care Unit (ICU), (2)whether cerebral (frontal) tissue haemoglobin oxygen saturation (StO2) values are associated with delirium in the ICU and (3) the association of frontal and peripheral StO2 with other micro- and macrohemodynamic parameters in this patient group , (4) to deduce the associations between shock, endotheliopathy, disseminated intravascular coagulation (DIC) and tissue perfusion and, last, the feasibility of central and peripheral NIRS monitoring in shock patients in the ICU using the Medtronic INVOS NIRS StO2 appliances. In addition, the investigators target to evaluate (5) the incidence, evolution, and outcome of sepsis-associated DIC, and (6) the associations between a) continuous hemodynamic data, b) laboratory data (such as syndecan-1 (SDC-1), vascular adhesion protein 1 (VAP1), CD73, heparin binding protein (HBP), endostatin, chromogranin, mitochondrial function tests,blood count d-dimer, international normalized ratio (INR), neuron specific enolase and metabolomics data) (7) and study associations of singlenucleotide polymorphisms with developing organ dysfunction and 90-day mortality. To compare the hemodynamic alterations of burn patients to septic patients with the intention to find new ways to monitor and manage hemodynamic and particularly microcirculation in burn patients.

Conditions

  • Circulatory Failure

Interventions

DEVICE

NIRS monitoring

Cerebral and peripheral NIRS monitoring of brain and tissue oxygenation. Of the 400 patients, a subpopulation of the first 250 adult critically ill patients (≥18 years) requiring ICU care, including both surgical and medical ICU patients with circulatory shock will be included in the NIRS-substudy. All 400 patients will be analyzed for endotheliopathy incidence, metabolomics, genetic data Representation of the study population will be ensured by enrolment of all consecutive patients at the study sites who meet the study enrollment criteria

Sponsors & Collaborators

  • Tampere University Hospital

    collaborator OTHER

  • Kuopio University Hospital

    collaborator OTHER

  • Medtronic

    collaborator INDUSTRY

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Erika Wilkman, MD, PhD · Helsinki University Central Hospital

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2023-06-30
Completion
2023-10-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03814564 on ClinicalTrials.gov