Cardiac ArrestNCT01455662
Relationship Between Tissue Markes in Patients With Post Cardio Respiratory Syndrome
An observational study of Cardiac Arrest, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
Trial summary
There is a correlation between hospital mortality and changes in markers of tissue perfusion, lactate, and venous oxygen saturation and carbon dioxide gradient. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Arrest
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Dec 2011
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients hospitalized in the intensive care unit after cardiopulmonary arrest
Who may be able to join
- All patients hospitalized in the intensive care unit after cardiopulmonary arrest with any pace
Who cannot join
- pregnant women, traumatized, post-operative(less 7 days), hypothermia and liver disease.
- patients hospitalized in the intensive care unit with more than 6 hours post cardiac arrest
- less 18 years old
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Conceição Hospital
Porto Alegre, Rio Grande do Sul
Vanessa Oliveira, MD
Diego Riveiro, MD
About this study
Official title: Relationship Between Lactate and Venous Oxygen Saturation Gradient of Carbon Dioxide in Patients With Post Cardio Respiratory Syndrome
There is a correlation between hospital mortality and changes in markers of tissue perfusion, lactate, and venous oxygen saturation and carbon dioxide gradient.
Read the detailed description
Evaluation of the serum carbon dioxide gradient (GapCO2), central venous saturation (ScvO2) and the clearance of serum lactate (Clac) in predicting hospital mortality after cardiac arrest syndrome (post-PCR).
Prospective study, unicenter - Intensive Care Unit - HNSC. Period: May/2010 to June/2011. Serial assessment of GapCO2 of ScvO2 Clac and the first 72 hours post-PCR. Excluded under 18, survival of less than 6HS, pregnant women, traumatized, post-operative hypothermia and liver disease. T-student test, 95% (p <0.05).
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest
- Medical subject headings
- Heart Arrest
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 |
|---|---|---|
| all patients after cardiac arrest | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 1 year
Secondary outcomes (1)
correlation of clearance markers of perfusion with the use of vasopressor and positive fluid balance
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Nossa Senhora da Conceicao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa Martins de oliveira, Hospital Nossa Senhora da Conceicao
- Investigators
- Vanessa Oliveira, MD, Principal investigator, Conceição HospitalDiego F Riveiro, MD, Principal investigator, Hospital Nossa Senhora da Conceição
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455662
- Sponsor's protocol ID
- 10086
- Status last verified
- Nov 2011
- First submitted
- 28 Sep 2011
- Last updated
- 3 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Lactate and Venous Oxygen Saturation Gradient of Carbon Dioxide in Patients With Post Cardio Respiratory Syndrome
- ClinicalTrials.gov ID
- NCT01455662
- Acronym / sponsor ID
- 10086
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Nossa Senhora da ConceicaoUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 20 Oct 2011 (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.
There is a correlation between hospital mortality and changes in markers of tissue perfusion, lactate, and venous oxygen saturation and carbon dioxide gradient.
Detailed description
Evaluation of the serum carbon dioxide gradient (GapCO2), central venous saturation (ScvO2) and the clearance of serum lactate (Clac) in predicting hospital mortality after cardiac arrest syndrome (post-PCR).
Prospective study, unicenter - Intensive Care Unit - HNSC. Period: May/2010 to June/2011. Serial assessment of GapCO2 of ScvO2 Clac and the first 72 hours post-PCR. Excluded under 18, survival of less than 6HS, pregnant women, traumatized, post-operative hypothermia and liver disease. T-student test, 95% (p <0.05).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients after cardiac arrest | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospitalized in the intensive care unit after cardiopulmonary arrest
Key inclusion criteria (1 listed)
- All patients hospitalized in the intensive care unit after cardiopulmonary arrest with any pace
Key exclusion criteria (3 listed)
- pregnant women, traumatized, post-operative(less 7 days), hypothermia and liver disease.
- patients hospitalized in the intensive care unit with more than 6 hours post cardiac arrest
- less 18 years old
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
mortality
Time frame: 1 year
1 secondary outcome
correlation of clearance markers of perfusion with the use of vasopressor and positive fluid balance
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2011.
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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.
Vanessa Oliveira, MD principal investigator
Conceição Hospital
Diego F Riveiro, MD principal investigator
Hospital Nossa Senhora da Conceição
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 Cardiac Arrest, run by Hospital Nossa Senhora da Conceicao at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 3 Nov 2011. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanessa M Oliveira, MD (05192513723, vanessa.oliveira480@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 1 year). 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 3 Nov 2011.