ShockPALVOSNCT01696175
PICU Admission Lactate and Central Venous Oxymetry Study
An observational study of Shock, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 1 week to 16 years
- Conditions the study is for
- Shock
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2012to Apr 2017
- Phase
- Observational
- 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 week to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Shock
- Keywords
- ScvO2, venous, oxymetry, lactate, children, PICU, Admission parameters of shock
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PICU admittance | Children equipped with an arterial and a central venous catheter within 12 hours after admittance to a Dutch PICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: first 24 hours after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: Researcher stopped activity at institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Dutch Network of Excellence for Pediatric Intensive Care Research
- Responsible party
- Principal investigator, Joris Lemson, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696175
- Sponsor's protocol ID
- PALVOS
- Acronym
- PALVOS
- Status last verified
- Sep 2017
- First submitted
- 26 Sep 2012
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactate Levels and Venous Oxygen Saturation in Children Admitted to a Dutch PICU
- ClinicalTrials.gov ID
- NCT01696175
- Acronym / sponsor ID
- PALVOS / PALVOS
- Conditions
- Shock
- Keywords
- ScvO2, venous, oxymetry, lactate, children, PICU, Admission parameters of shock
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Researcher stopped activity at institution
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- The Dutch Network of Excellence for Pediatric Intensive Care Research
- Study start
- Sep 2012
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 28 Sep 2012 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PICU admittance | – | –Children equipped with an arterial and a central venous catheter within 12 hours after admittance to a Dutch PICU |
Who may qualify
- Ages
- 1 week to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: first 24 hours after admission
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
Results and safety
The study was stopped early (reason given: Researcher stopped activity at institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, run by Radboud University Medical Center at 1 site in Netherlands.
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 6 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: stopped early, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 was stopped early (reason given: Researcher stopped activity at institution). Results are not available in the source record.
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?
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 (time frame: first 24 hours after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2017.