PICU Admission Lactate and Central Venous Oxymetry Study (PALVOS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The Dutch Network of Excellence for Pediatric Intensive Care Research
Information provided by (Responsible Party):
Joris Lemson, Radboud University
ClinicalTrials.gov Identifier:
NCT01696175
First received: September 26, 2012
Last updated: October 3, 2012
Last verified: October 2012
  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

Resource links provided by NLM:


Further study details as provided by Radboud University:

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

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
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696175

Contacts
Contact: Joris Lemson, MD PhD j.lemson@ic.umcn.nl
Contact: Luc Frijns, MD l.frijns@ic.umcn.nl

Locations
Netherlands
RUNMC Recruiting
Nijmegen, Netherlands
Contact: Luc Frijns, MD       l.frijns@ic.umcn.nl   
Contact: Joris Lemson, MD PhD       j.lemson@ic.umcn.nl   
Sponsors and Collaborators
Radboud University
The Dutch Network of Excellence for Pediatric Intensive Care Research
  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

ClinicalTrials.gov processed this record on October 22, 2014