Status:
COMPLETED
ASSESSment of Perfusion, Oxygen Saturation, Endothelial Function and Coagulation in Circulatory SHOCK
Lead Sponsor:
Helsinki University Central Hospital
Collaborating Sponsors:
Tampere University Hospital
Kuopio University Hospital
Conditions:
Circulatory Failure
Eligibility:
All Genders
18-100 years
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 a...
Detailed Description
Background: Circulatory shock is a frequent condition in the intensive care unit, comprising roughly one of three patients in the intensive care unit (ICU), and associated with high mortality rates. ...
Eligibility Criteria
Inclusion
- 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
- OR
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
April 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT03814564
Start Date
April 1 2019
End Date
October 31 2023
Last Update
March 21 2024
Active Locations (3)
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1
Helsinki University Hospital
Helsinki, Finland, 00029
2
Kuopio University Hospital
Kuopio, Finland, 70029 KYS
3
Tampere University Hospital
Tampere, Finland, 33521 Tampere