PICU Admission Lactate and Central Venous Oxymetry Study (PALVOS)
Observational multicentre cohort study. Children admitted to a Dutch PICU are studied for lactate levels and ScvO2. Children instrumented with arterial and central venous catheters are included within the first 12 hours after admittance.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Lactate Levels and Venous Oxygen Saturation in Children Admitted to a Dutch PICU|
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Children equipped with an arterial and a central venous catheter within 12 hours after admittance to a Dutch PICU
Rationale: Hemodynamic therapy in children with circulatory insufficiency requires the use of hemodynamic monitoring parameters including parameters that reflect tissue/organ oxygenation and oxygen utilization. Two parameters are readily available at the bedside that may reflect this: arterial lactate level and central venous oxygen saturation (ScvO2). To date is it unknown if these parameters are useful in guiding treatment of critically ill children. Also it is unknown how often lactate and ScvO2 are abnormal in children admitted to a Dutch PICU or if they are related to each.
Objective: The objective of this study is to find the incidence of a raised lactate level and or a decreased ScvO2, to study their mutual relation and to study the relation between lactate, ScvO2 and outcome parameters in children admitted to a Dutch PICU.
Study design: Observational cohort study
Study population: children admitted to a PICU <= 16 years
Intervention (if applicable): No intervention
Main study parameters/endpoints: Arterial lactate level, central venous oxygen saturation (ScvO2), arterial blood gas analysis and general hemodynamic variables in the first 24 hours after admission. Parameters for organ dysfunction, severity of illness and outcome parameters like length of PICU stay.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This is a strict observational design. No blood samples are taken for the purpose of this study. No intravascular catheters are inserted for the purpose of this study. No treatment strategy is associated with this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696175
|Contact: Joris Lemson, MD PhDemail@example.com|
|Contact: Luc Frijns, MDfirstname.lastname@example.org|
|Contact: Luc Frijns, MD email@example.com|
|Contact: Joris Lemson, MD PhD firstname.lastname@example.org|