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

NCT03814564 | Completed DMC

• 1 other identifier: HUS/420/2018
• Study Type: observational
• Target: 325
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (4)

• Change in severity of Organ dysfunction during the first week in ICU (study period)

  Change in the total Sequential Organ Failure Assessment (SOFA) score from day 1 to day 7 in the ICU, higher SOFA score indicates greater severity of organ failure, the total SOFA score ranges from 0-24 points

  At 7 days in ICU

• Average severity of Organ dysfunction during the first 7 days in the ICU (study period)

  Average Sequential Organ Failure Assessment (SOFA) during days 1 to day 7 in the ICU, higher SOFA score indicates greater severity of organ failure, the total SOFA score ranges from 0-24 points

  First week in the Intensive Care Unit after admission

• New organ dysfunctions

  Number of new organ dysfunctions (new organ dysfunction defined as one of 6 SOFA subscores ≥3 points/ total 4 points, higher points indicate greater severity. Only one new organ dysfunction / each subscore can be used for calculation of total number of new organ dysfunctions in one week

  First week in the Intensive Care Unit after admission

• 90-day mortality

  Death within 90 days from ICU admission

  90 days

Secondary Outcomes (11)

• Intensive care delirium incidence

  First week in the Intensive Care Unit after admission

• Intensive care delirium severity

  First week in the Intensive Care Unit after admission

• Intensive care delirium scoring checklist aggregate and average score during first week in intensive care

  First week in the Intensive Care Unit after admission

• INVOS NIRS feasibility and safety questionnaire

  0-48 hours in Intensive Care Unit after enrolment into study

• Time to Extubation

  28 days

Other Outcomes (1)

• Glycocalyx and endothelial injury biomarkers such as: Syndecan-1 (SDC-1), vascular adhesion protein 1 (VAP1), CD73, heparin binding protein (HBP), angiopoietin-2, endostatin, chromogranin

  First week in the Intensive Care Unit after admission

Study Arms (3)

Circulatory failure / NIRS monitoring

Of the 400 patients, a subpopulation of the first 250 adult critically ill patients (≥18 years) requiring intensive care unit (ICU) care, including both surgical and medical ICU patients with circulatory shock will be included in the (near-infrared spectroscopy) NIRS-substudy.

Device: NIRS monitoring

Circulatory Failure / no NIRS monitoring

Of the 400 patients, a subpopulation of the first 250 adult critically ill patients (≥18 years) requiring intensive care unit(ICU) care, including both surgical and medical ICU patients with circulatory shock will be included in the near-infrared spectroscopy (NIRS) substudy. All 400 patients will be analyzed for endotheliopathy incidence, metabolomics, genetic data (without NIRS monitoring). Representation of the study population will be ensured by enrolment of all consecutive patients at the study sites who meet the study enrollment criteria.

Gut dysbiosis, delirium and long term cognition

ASSESS-shock participants that have been treated at Meilahti ICU:s and survived the ICU admission to discharge, who are living in the Helsinki and Uusimaa Hospital District area or reasonable traveling distance to the unit for cognitive testing. Cognitive function testing is performed after ICU discharge and at 3 and 6 months after ICU discharge. Testing of the microbiome is performed by collecting and analyzing fecal samples at ICU admission and at 7 days after ICU admission.

Interventions

NIRS monitoring DEVICE

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

Circulatory failure / NIRS monitoring

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will comprise 400 critically ill patients with circulatory shock from 4 university hospitals during approximately 2 years between April 2019 and December 2021. 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 (without NIRS monitoring). Representation of the study population will be ensured by enrolment of all consecutive patients at the study sites who meet the study enrollment criteria.

You may qualify if:

• Age ≥ 18 Critically ill patients requiring Intensive Care Unit (ICU) care with circulatory shock within 4 hours (≤ hours) of ICU admission or with circulatory shock developing in the ICU within 24 hours from ICU admission and within 4 hours of initiation of vasopressor treatment presenting with the below listed signs of for circulatory shock
• Hypotension - need for vasopressor to achieve mean arterial pressure (MAP) ≥65 mmHg after 1L of crystalloid solution
• and
• Any sign of hypoperfusion (at least one of the signs below)
• blood lactate ≥2 mmol/L
• mottling score ≥ 2
• Base Excess (BE) ≤ - 5 mEq/L
• prolonged capillary refill time ≥ 2 s
• cool periphery beyond elbows or knees bilaterally
• altered mentation
• Confirmed or suspected infection and anti-microbial treatment
• OR as an independent criteria for the ASSESS-SHOCK BURNS substudy
• Burn injury ≥30% total body surface area(TBSA), ICU admission within 12h of the injury, with or without hypotension and signs of hypoperfusion within 4 hours of ICU admission

You may not qualify if:

• Age \< 18 years
• Pregnant or lactating
• Known refusal to any clinical study or this specific study
• Consent not obtained (according to local regulatory statements for ethical conduct of research)
• Out-of-hospital cardiac arrest (OHCA) patients
• Terminal illness and not considered for full intensive care support
• Planned postoperative admission
• Postoperative intensive care after organ transplantation
• Patients who are likely to be transferred to the ward in 24 hours
• Defects of skin, underlying tissues or extremities preventing the use of the central or peripheral NIRS probes (the first 250 enrolled patients)

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Tampere University Hospital: collaborator
• Kuopio University Hospital: collaborator
• Medtronic: collaborator

Study Sites (3)

Helsinki University Hospital

Helsinki, 00029, Finland

Location

Kuopio University Hospital

Kuopio, 70029 KYS, Finland

Location

Tampere University Hospital

Tampere, 33521 Tampere, Finland

Location

Related Publications (1)

• Varis E, Heliste M, Hastbacka J, Vaara ST, Skrifvars MB, Pettila V, Laaperi M, Kuitunen A, Vahtera A, Wilkman E. Clinical outcomes and peripheral tissue oxygen saturation monitoring of the knee region by near-infrared spectroscopy in circulatory shock: a prospective observational cohort study. Crit Care. 2025 Mar 19;29(1):125. doi: 10.1186/s13054-025-05363-1.

  PMID: 40108719 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected for later analysis of metabolomics, patient-related changes in biomarkers indicating endothelial and myocardial damage, coagulopathies and brain injury from consenting patients (such as syndecan-1 (SDC-1), vascular adhesion protein 1 (VAP1), CD73, heparin binding protein (HBP), endostatin, chromogranin, mitochondrial function tests and regulators (FGF-21 and GDF-15), blood count d-dimer, INR, neuron specific enolase). A separate sample for genetic analysis will be obtained that will be stored and processed further only if patient/next of kin provides the separately asked consent for the genetic analysis.

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Erika Wilkman, MD, PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Adjunct Professor

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 24, 2019
• Study Start: April 1, 2019
• Primary Completion: June 30, 2023
• Study Completion: October 31, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (3)