Does Preconditioning Affects Other Organs in Patients Undergoing Open Heart Surgery ?
Variable Types of Preconditioning,is There a Different Impact Upon Multiorgan Function After Open Heart Surgery ?
1 other identifier
interventional
100
1 country
1
Brief Summary
An association between white blood cell count (WBC), neutrophil-lymphocyte ratio , and inflammatory process is well known . Ischemic preconditioning reduces the inflammation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2016
Shorter than P25 for not_applicable
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
Study Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 21, 2017
CompletedFirst Posted
Study publicly available on registry
March 31, 2017
CompletedDecember 21, 2017
December 1, 2017
7 months
March 21, 2017
December 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change of Neutrophil lymphocyte ratio
during first two postoperative days
Study Arms (2)
Ischemic preconditioing
ACTIVE COMPARATOR50 patients ischemic preconditioning will be done after induction and before cardiopulmonary bypass by inflation the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3cycles
Pharmacologic preconditioing
ACTIVE COMPARATORby sevoflurane anesthesia
Interventions
ischemic preconditioning will be done after induction and before cardiopulmonary bypass by inflation the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3cycles
Pharmacologic preconditionig will be attained by sevoflurane anesthesia
Eligibility Criteria
You may qualify if:
- years old
- American Society of Anesthesiologists physical status II and III
- Patients scheduled for open heart surgery
- no active inflammatory process
You may not qualify if:
- Emergency surgery
- Clinically significant kidney or liver disease
- Patients allergic to local anesthetic
- Patients with prolonged cardiopulmonary bypass time (\>120 min)
- Patients required intra-aortic balloon pump
- Postoperative hemodynamic instability (including the occurrence of serious arrhythmia) or bleeding that required surgical re-exploration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emad Zarief Kamel Said
Asyut, 71111, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Anesthesia and critical care Medicine
Study Record Dates
First Submitted
March 21, 2017
First Posted
March 31, 2017
Study Start
May 1, 2016
Primary Completion
December 1, 2016
Study Completion
March 1, 2017
Last Updated
December 21, 2017
Record last verified: 2017-12