Impact of Variable Types of Preconditioning Upon the Inotrope Score in Adult Patients, Undergoing Cardiac Surgery
1 other identifier
interventional
100
1 country
1
Brief Summary
Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart from subsequent ischemia. PC stimulus may be (ischemic ; pharmacologic or Physical).
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 Mar 2016
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
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 17, 2016
CompletedFirst Posted
Study publicly available on registry
March 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedDecember 12, 2017
December 1, 2017
1 year
March 17, 2016
December 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Highest inotropic score
first 24 hour
Study Arms (2)
A pharmacologic cardiac preconditioning
ACTIVE COMPARATORSevoflurane as a pharmacologic preconditioner for the heart
B ischeamic preconditioning
ACTIVE COMPARATORischemic preconditioning by inflation the cuff of blood pressure
Interventions
A Patients are anaesthetized by Sevoflurane more than 1 mac.
B 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
Eligibility Criteria
You may qualify if:
- years old
- American Society of Anesthesiologists physical status II and III
- Patients scheduled for open heart surgery
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 Officials
- STUDY DIRECTOR
Emad Zarief Kamel Said, M.D.
Department of Anesthesia, faculty of Medicine, Assiut University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Anesthesia and critical care Medicine
Study Record Dates
First Submitted
March 17, 2016
First Posted
March 22, 2016
Study Start
March 1, 2016
Primary Completion
March 1, 2017
Study Completion
June 1, 2017
Last Updated
December 12, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share