NCT02715869

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 12, 2017

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

March 17, 2016

Last Update Submit

December 9, 2017

Conditions

Keywords

Myocardial Preconditioning, inotropic score

Outcome Measures

Primary Outcomes (1)

  • Highest inotropic score

    first 24 hour

Study Arms (2)

A pharmacologic cardiac preconditioning

ACTIVE COMPARATOR

Sevoflurane as a pharmacologic preconditioner for the heart

Drug: A pharmacologic cardiac preconditioning (Sevoflurane)

B ischeamic preconditioning

ACTIVE COMPARATOR

ischemic preconditioning by inflation the cuff of blood pressure

Procedure: B ischeamic preconditioning

Interventions

A Patients are anaesthetized by Sevoflurane more than 1 mac.

A pharmacologic cardiac preconditioning

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

B ischeamic preconditioning

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Emad Zarief Kamel Said, M.D.

    Department of Anesthesia, faculty of Medicine, Assiut University

    STUDY DIRECTOR

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

Locations