Biomarker analysis in septic intensive care patients

Biomarker analysis in septic intensive care patients - The BASIC-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36605

Enrollment

2067

Registered

2011-09-16

Start date

2011-04-04

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blood poisoning Sepsis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age: 18 years and older Presence of an arterial line;Sepsis group: Patients admitted to the intensive care with sepsis, or patients developing sepsis during their stay on the intensive care.;SIRS patients: Critically ill patients who score positive on at least two SIRS criteria who do not suffer from sepsis and have an expected ICU stay of more than 24 hours.;Healthy volunteers: All healthy individuals without any recent febrile or infectious illness (within 2 weeks). Individuals capable of giving written informed consent.

Exclusion criteria

Exclusion criteria: No informed consent;Patients receiving more than 24 hours of antibiotic treatment for a suspected infection prior to ICU admission.;Sepsis group: Previous participation in this study.;SIRS group: Previous participation in this study.;Healthy volunteers: Previous participation in this study. A major illness in the past 3 months or any significant chronic medical illness that the investigator would deem unfavorable for enrolment, including inflammatory diseases. A recent febrile illness (within 2 weeks). Recent use of anti-inflammatory medication (within 2 weeks). Subject using tobacco and/or illicit drug products. Current use of hormone therapy or current pregnancy. Limited accessibility of a vein in the left or right arm.

Design outcomes

Primary

Measure	Time frame
90-day mortality	—

Secondary

Measure	Time frame
-Multi organ dysfunction syndrome (MODS) according to Marshall criteria increasing abnormalities in the following organ specific parameters: PO2/FiO2 ratio (lung) Serum creatinine (kidney) Platelet count (clotting system) Glasgow coma score (neurological) Serum bilirubin (hepatic) Pressure-adjusted heart rate (HR): (HR x (Central Venous Pressure/Mean Arterial Pressure)) (heart) -Etiology (bacterial and/or viral) -CRP,CRP-complement complex -Parameters of systemic inflammation (cytokines, chemokines, complement activation, cell numbers and differentiates) -Parameters of local inflammation (cytokines, chemokines, complement activation, cell numbers and differentiates) -Coagulation/fibrinolysis parameters (both systemic and local) -Markers for cellular damage -Demographic data, medical history and health condition prior to hospitalization will be documented for all patients.	—

Measure

Time frame

-Multi organ dysfunction syndrome (MODS) according to Marshall criteria increasing abnormalities in the following organ specific parameters: PO2/FiO2 ratio (lung) Serum creatinine (kidney) Platelet count (clotting system) Glasgow coma score (neurological) Serum bilirubin (hepatic) Pressure-adjusted heart rate (HR): (HR x (Central Venous Pressure/Mean Arterial Pressure)) (heart) -Etiology (bacterial and/or viral) -CRP,CRP-complement complex -Parameters of systemic inflammation (cytokines, chemokines, complement activation, cell numbers and differentiates) -Parameters of local inflammation (cytokines, chemokines, complement activation, cell numbers and differentiates) -Coagulation/fibrinolysis parameters (both systemic and local) -Markers for cellular damage -Demographic data, medical history and health condition prior to hospitalization will be documented for all patients.

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Countries

Netherlands

Outcome results