Relationship Between Tissue Markes in Patients With Post Cardio Respiratory Syndrome
This study is currently recruiting participants.
Verified November 2011 by Hospital Nossa Senhora da Conceicao
Sponsor:
Hospital Nossa Senhora da Conceicao
Information provided by (Responsible Party):
Vanessa Martins de oliveira, Hospital Nossa Senhora da Conceicao
ClinicalTrials.gov Identifier:
NCT01455662
First received: September 28, 2011
Last updated: November 2, 2011
Last verified: November 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 28, 2011 | ||||||||
| Last Updated Date | November 2, 2011 | ||||||||
| Start Date ICMJE | January 2010 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01455662 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
correlation of clearance markers of perfusion with the use of vasopressor and positive fluid balance [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Relationship Between Tissue Markes in Patients With Post Cardio Respiratory Syndrome | ||||||||
| Official Title ICMJE | Relationship Between Lactate and Venous Oxygen Saturation Gradient of Carbon Dioxide in Patients With Post Cardio Respiratory Syndrome | ||||||||
| Brief Summary | There is a correlation between hospital mortality and changes in markers of tissue perfusion, lactate, and venous oxygen saturation and carbon dioxide gradient. |
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| 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). |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | patients hospitalized in the intensive care unit after cardiopulmonary arrest |
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| Condition ICMJE | Cardiac Arrest | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | all patients after cardiac arrest | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | December 2011 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: pregnant women, traumatized, post-operative(less 7 days), hypothermia and liver disease.
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Brazil | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01455662 | ||||||||
| Other Study ID Numbers ICMJE | 10086 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Vanessa Martins de oliveira, Hospital Nossa Senhora da Conceicao | ||||||||
| Study Sponsor ICMJE | Hospital Nossa Senhora da Conceicao | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Hospital Nossa Senhora da Conceicao | ||||||||
| Verification Date | November 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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