PICU Admission Lactate and Central Venous Oxymetry Study (PALVOS)
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Purpose
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.
| Condition |
|---|
|
Shock |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Lactate Levels and Venous Oxygen Saturation in Children Admitted to a Dutch PICU |
| Estimated Enrollment: | 500 |
| 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) |
| Groups/Cohorts |
|---|
|
PICU admittance
Children equipped with an arterial and a central venous catheter within 12 hours after admittance to a Dutch PICU
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Detailed Description:
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.
Eligibility| Ages Eligible for Study: | up to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Al children admitted to a PICU <= 16 years equipped with an arterial and central venous catheter in situ at admission or inserted within < 12 hours after admission to the PICU.
Inclusion Criteria:
- Al children admitted to a PICU <= 16 years equipped with an arterial and central venous catheter in situ at admission or inserted within < 12 hours after admission to the PICU
Exclusion Criteria:
- Patients without an arterial or central venous catheter > 12 hours after of admission
- Patients with a known underlying metabolic disorder causing an elevated lactate level
- Patients with asthma and therapy (nebulized or intravenous) with salbutamol.
- Patients with an intoxication causing elevated lactate levels
- Premature children (<38 weeks GA)
- Patients on ECMO
Contacts and Locations| Contact: Joris Lemson, MD PhD | j.lemson@ic.umcn.nl | |
| Contact: Luc Frijns, MD | l.frijns@ic.umcn.nl |
| Netherlands | |
| RUNMC | Recruiting |
| Nijmegen, Netherlands | |
| Contact: Luc Frijns, MD l.frijns@ic.umcn.nl | |
| Contact: Joris Lemson, MD PhD j.lemson@ic.umcn.nl | |
More Information
No publications provided
| Responsible Party: | Joris Lemson, Medical director pediatric intensive care unit, Radboud University |
| ClinicalTrials.gov Identifier: | NCT01696175 History of Changes |
| Other Study ID Numbers: | PALVOS |
| Study First Received: | September 26, 2012 |
| Last Updated: | October 3, 2012 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by Radboud University:
|
ScvO2 venous oxymetry lactate |
children PICU Admission parameters of shock |
Additional relevant MeSH terms:
|
Shock Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013