Severe SepsisNCT00407823
Comparison of Pediatric Septic Shock Treatment With and Without Central Venous Oxygen Saturation Monitoring
A study testing Central venous oxygen saturation continuous monitoring in people with Severe Sepsis and Septic Shock, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 19 years
- Conditions the study is for
- Severe Sepsis, Septic Shock
- What is being tested?
- Central venous oxygen saturation continuous monitoring
- Type of treatment
- Surgery or procedure
- How many people
- 268 participants
- Where
- 2 sitesBrazil
- Study dates
- Jan 2004to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Instituto da Criança - HC-FMUSP
São Paulo, São Paulo, 05409-002
Hospital Universitário - USP
São Paulo, São Paulo
About this study
Official title: An Outcomes Comparison of ACCM/PALS Guidelines For Pediatric Septic Shock 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.
Read the detailed description
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.
- Conditions
- Severe Sepsis, Septic Shock
- Being tested
- Central venous oxygen saturation continuous monitoring
- Keywords
- Child, Septic shock, Resuscitation, Central venous oxygen saturation, Cardiac output, Goal-directed therapy
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central venous oxygen saturation continuous monitoringProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
Secondary outcomes (7)
Number of organ dysfunction
Administered treatments
Duration of cardiovascular agents therapy
Duration of mechanical ventilation
Length of Pediatric Intensive Care Unit stay
Days free of cardiovascular agents
Days free of mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startJan 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 268 participants
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Claudio F Oliveira, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407823
- Sponsor's protocol ID
- 2004/07949-7
- Other IDs
- 2004
- Status last verified
- Dec 2006
- First submitted
- 4 Dec 2006
- Last updated
- 5 Dec 2006
- Results posted
- No
Publications
Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
PubMed 11794169de Oliveira CF, de Oliveira DS, Gottschald AF, Moura JD, Costa GA, Ventura AC, Fernandes JC, Vaz FA, Carcillo JA, Rivers EP, Troster EJ. ACCM/PALS haemodynamic support guidelines for paediatric septic shock: an outcomes comparison with and without monitoring central venous oxygen saturation. Intensive Care Med. 2008 Jun;34(6):1065-75. doi: 10.1007/s00134-008-1085-9. Epub 2008 Mar 28.
PubMed 18369591
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Outcomes Comparison of ACCM/PALS Guidelines For Pediatric Septic Shock With and Without Central Venous Oxygen Saturation Monitoring
- ClinicalTrials.gov ID
- NCT00407823
- Acronym / sponsor ID
- 2004/07949-7
- Conditions
- Severe Sepsis, Septic Shock
- Keywords
- Child, Septic shock, Resuscitation, Central venous oxygen saturation, Cardiac output, Goal-directed therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jan 2004
- Study completion
- Aug 2005
- First posted
- 5 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 1 month to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Central venous oxygen saturation continuous monitoring | Procedure or surgery | – |
Primary outcome
28-day mortality
7 secondary outcomes
Number of organ dysfunction
Administered treatments
Duration of cardiovascular agents therapy
Duration of mechanical ventilation
Length of Pediatric Intensive Care Unit stay
Days free of cardiovascular agents
Days free of mechanical ventilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2006.
- Results publication: PubMed 11794169Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
- Derived from this study: PubMed 18369591de Oliveira CF, de Oliveira DS, Gottschald AF, Moura JD, Costa GA, Ventura AC, Fernandes JC, Vaz FA, Carcillo JA, Rivers EP, Troster EJ. ACCM/PALS haemodynamic support guidelines for paediatric septic shock: an outcomes comparison with and without monitoring central venous oxygen saturation. Intensive Care Med. 2008 Jun;34(6):1065-75. doi: 10.1007/s00134-008-1085-9. Epub 2008 Mar 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio F Oliveira, MD principal investigator
University of Sao Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Central venous oxygen saturation continuous monitoring in people with Severe Sepsis and Septic Shock, run by University of Sao Paulo at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00407823, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2006.