NCT03097692

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

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 May 2016

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
Last Updated

December 21, 2017

Status Verified

December 1, 2017

Enrollment Period

7 months

First QC Date

March 21, 2017

Last Update Submit

December 20, 2017

Conditions

Keywords

cardiac preconditioningopen heart surgerycreatenineinflammation

Outcome Measures

Primary Outcomes (1)

  • change of Neutrophil lymphocyte ratio

    during first two postoperative days

Study Arms (2)

Ischemic preconditioing

ACTIVE COMPARATOR

50 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

Procedure: ischemic preconditioning

Pharmacologic preconditioing

ACTIVE COMPARATOR

by sevoflurane anesthesia

Drug: Pharmacologic preconditionig

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

Ischemic preconditioing

Pharmacologic preconditionig will be attained by sevoflurane anesthesia

Pharmacologic preconditioing

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
  • 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

Location

MeSH Terms

Conditions

Inflammation

Interventions

Ischemic Preconditioning

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: intervention group well be pretreated with cardiac preconditioning
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

Locations