Application of Remote Ischemic Preconditioning in Patients Undergoing Open Heart Surgeries
Evaluation of Remote Preconditioning on Heart Resistance to Ischemia and Reperfusion Injury
1 other identifier
interventional
120
1 country
1
Brief Summary
Strategies for myocardial protection during open heart surgeries are desired. Several experimental studies have shown beneficial effects of remote ischemic preconditioning (RIPC). The underlying mechanisms are not totally understood. This study intends to evaluate molecular mechanisms involved with RIPC on myocardium of patients underwent open heart surgeries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Aug 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2013
CompletedFirst Posted
Study publicly available on registry
July 24, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedNovember 28, 2013
November 1, 2013
2 years
July 21, 2013
November 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Molecular pathway activation
2 days
Inflammatory response
10 days
Secondary Outcomes (2)
All cause of mortality
30 days
All cause of mortality
180 days
Study Arms (2)
IRPC, Remote preconditioning
EXPERIMENTALThis group will be submitted to ischemic preconditioning
Control
PLACEBO COMPARATORThis patients will be submitted to the standard surgery protocol in the institution. The patients will not be submitted to 5 minutes of upper limb compression by cuff followed by 5 minutes of reperfusion.
Interventions
The patients will be submitted to 5 minutes of upper limb compression by cuff followed by 5 minutes of reperfusion. This cycle will be repeated 4 times.
Eligibility Criteria
You may qualify if:
- Patients older than 18 years
- Scheduled for coronary artery bypass grafting with or without valve replacement associated
- Use of blood cardioplegia
- EuroSCORE II greater than or equal to 1.0%
You may not qualify if:
- History of cardiogenic shock
- Complications in the admission
- Pregnant patients
- Severe peripheral arterial disease affecting the upper limbs
- Liver failure (bilirubin ˃ 20 mmol / L, INR 2.0 ˃)
- Significant pulmonary disease (˂ FEV1 40%)
- Renal failure with glomerular filtration rate ˂ ml/min/1,73 m²
- Concomitant treatment with glibenclamide or nicorandil (medications that interfere with cardioprotection induced by IPCR)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital das Clínicas da Unicamp
Campinas, São Paulo, 13100000, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Orlando Petrucci, MD, PhD
University of Campinas
- PRINCIPAL INVESTIGATOR
Fany Lima, RN
University of Campinas
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Phd
Study Record Dates
First Submitted
July 21, 2013
First Posted
July 24, 2013
Study Start
August 1, 2013
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
November 28, 2013
Record last verified: 2013-11