PICU Admission Lactate and Central Venous Oxymetry Study (PALVOS)

Lactate Levels and Venous Oxygen Saturation in Children Admitted to a Dutch PICU

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 Overview

• Status: Terminated
• Conditions: Shock

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands
    • RUNMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
PICU admittance; Children equipped with an arterial and a central venous catheter within 12 hours after admittance to a Dutch PICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
What is the incidence of a decreased ScvO2 and or a raised lactate level in children admitted to Dutch PICU's in the first 24 hours after admission to the PICU	What is the incidence of a decreased ScvO2 and or a raised lactate level in children admitted to Dutch PICU's in the first 24 hours after admission to the PICU	first 24 hours after admission

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: The Dutch Network of Excellence for Pediatric Intensive Care Research

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: September 26, 2012
• First Submitted That Met QC Criteria: September 27, 2012
• First Posted (Estimate): September 28, 2012

Study Record Updates

• Last Update Posted (Actual): October 2, 2017
• Last Update Submitted That Met QC Criteria: September 28, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: children; lactate; venous; PICU; ScvO2; oxymetry; Admission parameters of shock
• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: PALVOS