Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178822
Status:
RECRUITING
Last Update Posted:
2023-12-21
First Post:
2023-11-23
Brief Title:
Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room
Sponsor:
Amsterdam University Medical Centers UMC Location Academic Medical Center AMC
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOSEP
Brief Summary:
Objectives
1 To compare the immune response of patients with or without sepsis presenting to the ED with an suspected infection
2 To determine immune response aberrations that are associated with an increased risk of developing sepsis in patients presenting to the ED with an suspected infection without sepsis
3 To determine the long term cognitive and physical sequelae of sepsis after admission
1 To compare the immune response of patients with or without sepsis presenting to the ED with an suspected infection
2 To determine immune response aberrations that are associated with an increased risk of developing sepsis in patients presenting to the ED with an suspected infection without sepsis
3 To determine the long term cognitive and physical sequelae of sepsis after admission
Detailed Description:
Sepsis will be defined in accordance with the current Sepsis 30 criteria as an suspected infection with evidence of organ failure as reflected by a SOFA Sequential Organ Failure Assessment score of 2 Notably a molecular definition of sepsis does not exist and there is no pathological gold standard therefore in accordance with the current international consensus the investigators consider the commonly used clinical organ failure SOFA criteria as the best option The SOFA score is composed of six organ dysfunctions cardiovascular pulmonary renal hepatic coagulation and neurological The SOFA score was developed for ICU patients but its components can be easily scored in an ED and hospital ward setting with the exception of the pulmonary component this pulmonary dysfunction score is based on the PaO2FiO2 PF ratio wherein PaO2 is the partial pressure of oxygen in arterial blood and FiO2 the fraction of inspired oxygen Measurement of the PaO2 requires an arterial blood puncture which is not routinely done on the ER or hospital ward Therefore the investigators will use an alternative method to determine the respiratory SOFA by determining the SpO2FiO2 SF ratio wherein SpO2 is peripheral oxygen saturation SpO2 is routinely measured by finger pulse oximeter in patients with suspected infection FiO2 is 21 when breathing room temperature and increases by 4 with each liter of oxygen provided per minute to a patient via a nasal cannula Cut-off values for SF ratios correlating with SOFA pulmonary scores based on PF ratios have been validated in large data sets
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None