Relationship between coagulation disturbances and microcirculation alterations and the development of multi-organ failure in sepsis

Relationship between coagulation disturbances and microcirculation alterations and the development of multi-organ failure in sepsis - Coagulation and microcirculation disturbances in sepsis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39381

Enrollment

Registered

2013-03-19

Start date

2013-03-30

Completion date

Unknown

Last updated

2024-04-29

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: - patients 18 years and older admitted to the intensive care unit with severe sepsis and septic shock

Exclusion criteria

Exclusion criteria: -active bleeding at time of inclusion -pre-existing haematological disorders such as protein C or S deficiency, haemophila -therapeutic anticoagulation -recently documented (within 3 months of study entry) or highly suspected deep vein thrombosis or pulmonary embolus - pregnancy - chronic liver failure with an protrombin prolongation (international normalized ratio >1.2)

Design outcomes

Primary

Measure	Time frame
Thromboelastometry parameters measured with ROTEM®: • Clotting time (CT) • Clot formation time (CFT) • alfa-angle • Maximum clot firmness (MCF) • Maximum lysis (ML) and Lysis index (LI) Sidestream dark field imaging parameters: MFI (microvascular flow index), the heterogeneity index, PVD (perfused vessel density density), PPV (proportion of perfused vessels).	—

Secondary

Measure	Time frame
Standard coagulation and fibrinolysis parameters: • Hemoglobin (Hb) and Hematocrit (Ht) • Platelet count • Activated partial thromboplastin time (aPTT) • Prothrombin time (PT) • Fibrinogen • D-dimer Standard inflammation parameters • CRP • PCT Other study parameters (if applicable) - Demographic characteristics - Diffuse intravascular coagulation (DIC) score - Sequential organ failure assessment (SOFA) score - Acute Physiology and Chronic Health Evaluation, APACHE II and IV - Length of stay ICU and hospital - Hospital, ICU and 30 day mortality - Days on ventilator support - Systemic hemodynamics - SvO2 if a central line is placed in the subclavian or jugular vein - Administration of fluids and fluid balances - Vasopressor, vasodilatators and inotropic dose - Comorbidity and other comedication - Administration of blood products - Thrombo-embolic or bleeding complications - Site and type of infection - (time to) Source control	—

Measure

Time frame

Standard coagulation and fibrinolysis parameters: • Hemoglobin (Hb) and Hematocrit (Ht) • Platelet count • Activated partial thromboplastin time (aPTT) • Prothrombin time (PT) • Fibrinogen • D-dimer Standard inflammation parameters • CRP • PCT Other study parameters (if applicable) - Demographic characteristics - Diffuse intravascular coagulation (DIC) score - Sequential organ failure assessment (SOFA) score - Acute Physiology and Chronic Health Evaluation, APACHE II and IV - Length of stay ICU and hospital - Hospital, ICU and 30 day mortality - Days on ventilator support - Systemic hemodynamics - SvO2 if a central line is placed in the subclavian or jugular vein - Administration of fluids and fluid balances - Vasopressor, vasodilatators and inotropic dose - Comorbidity and other comedication - Administration of blood products - Thrombo-embolic or bleeding complications - Site and type of infection - (time to) Source control

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Countries

Netherlands

Outcome results