Investigate the incidence and severity of early coagulopathy in severe sepsis and septic shock patients and investigate the correlation between these coagulation disturbances and the incidence and severity of microvascular changes.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Decreased and nonspecific blood pressure disorders and shock
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
During severe sepsis and septic shock both activation of coagulation and
alterations of the microvasculature are common. The degree of coagulopathy as
well as the severity of microvascular alterations are both well correlated to
organ dysfunction and outcome. Moreover, coagulation abnormalities may cause
organ failure by contributing to the development of microvascular failure, this
is however a matter of debate. Traditional haemostatic parameters, used to
determine coagulation abnormalities, have the disadvantage of being time
consuming and more specific tests are not routinely available yet. Rotation
thrombelastometry (ROTEM©) can be useful to identify early coagulation
disturbances in sepsis at the moment when the microcirculation starts to
deteriorate. This could trigger earlier interventions diminishing morbidity and
mortality rates of sepsis.
In this study we aim to investigate whether early coagulation disturbances in
sepsis can be identified using ROTEM© and define the relationship with
microvasculature alterations measured with sidestream dark field (SDF) imaging.
Study objective
Investigate the incidence and severity of early coagulopathy in severe sepsis
and septic shock patients and investigate the correlation between these
coagulation disturbances and the incidence and severity of microvascular
changes.
Study design
prospective observational single-centre study
Study burden and risks
The burden of this study for the patient is minimal and exist of an additional
blood sampling of 36 mL in total for which we will use an existing intra
arterial line without the need to perform additional vena punctures.
Microscopic investigation are under the tonque, non-invasive, and will take
only a few minutes.
There is no benefit for the patient.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- patients 18 years and older admitted to the intensive care unit with
severe sepsis and septic shock
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39276.029.13 |