PICU Admission Lactate and Central Venous Oxymetry Study

Shock Clinical Trial

— PALVOS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01696175
• Other study ID #: PALVOS
• Status: Terminated
• Phase: N/A
• First received: September 26, 2012
• Last updated: September 28, 2017
• Start date: September 2012
• Est. completion date: April 2017

Study information

• Verified date: September 2017
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Shock

Locations

Country	Name	City	State
Netherlands	RUNMC	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	The Dutch Network of Excellence for Pediatric Intensive Care Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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