PICU Admission Lactate and Central Venous Oxymetry Study

NCT01696175 | Terminated

• 1 other identifier: PALVOS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shock

Keywords

ScvO2; venous; oxymetry; lactate; children; PICU; Admission parameters of shock

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PICU admittance

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

Eligibility Criteria

• Age: 1 Week - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

RUNMC

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical director pediatric intensive care unit

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: September 28, 2012
• Study Start: September 1, 2012
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: October 2, 2017

Record last verified: 2017-09

Locations

NL (1)