Skip to main content
OpenTrials
Completed

NCT Number: NCT00407823

Comparison of Pediatric Septic Shock Treatment With and Without Central Venous Oxygen Saturation Monitoring

The purpose of this study was to compare ACCM/PALS guidelines performed with and without central venous oxygen saturation monitoring on the morbidity and mortality rate of children with severe sepsis and septic shock.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Severe Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

1 month–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitário - USP, São Paulo, Brazil

Loading trial locations.

About this study

Background: ACCM/PALS guidelines addresses early correction of pediatric septic shock using physical examination supplemented by indirect measures of cardiac output such as central venous or superior vena cava oxygen saturation (ScvO2>70%) in a goal directed approach. However, these endpoints are based on unsupported evidence. The purpose of this study was to compare ACCM/PALS guidelines performed with and without ScvO2 on the morbidity and mortality rate of children with severe sepsis and septic shock.

Methods: Children and adolescents with severe sepsis or fluid-refractory septic shock were recruited at two university-affiliated hospitals and randomly assigned to ACCM/PALS without, or with an ScvO2 goal directed (goal ScvO2 > 70%) resuscitation. Twenty-eight day mortality is the primary end point.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with severe sepsis or fluid-refractory septic shock that had not responded after 40 mL/kg of any resuscitation fluid or that required cardiovascular agents at any time during resuscitation

Exclusion criteria

  • refusal to sign the written informed consent
  • age less than 1 month or older than 19 years
  • uncorrected cyanotic heart disease
  • patients receiving exclusive palliative care
  • patients that arrived from other hospitals more than 6 hours after the diagnosis of severe sepsis or septic shock.

Treatment and study plan

Central venous oxygen saturation continuous monitoring

Procedure

Primary outcomes

  1. 28-day mortality

Secondary outcomes

  1. Number of organ dysfunction

  2. Administered treatments

  3. Duration of cardiovascular agents therapy

  4. Duration of mechanical ventilation

  5. Length of Pediatric Intensive Care Unit stay

  6. Days free of cardiovascular agents

  7. Days free of mechanical ventilation

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

An Outcomes Comparison of ACCM/PALS Guidelines For Pediatric Septic Shock With and Without Central Venous Oxygen Saturation Monitoring

Important dates

Study start
2004
Study completion
2005
First posted
Dec 5, 2006
Registry last updated
Dec 5, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.