NCT03105089

Brief Summary

preconditioning of no debate has a valuable effect upon myocardial protection . pre-cardiopulmonary bypass pre-conditioning , suspected to have a role upon postoperative inotropic support

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 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
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

11 months

First QC Date

April 2, 2017

Last Update Submit

October 27, 2017

Conditions

Open Heart SurgeryPreconditioning

Outcome Measures

Primary Outcomes (1)

  • inotropic score

    48 hours

Secondary Outcomes (1)

  • renal function

    2 dyas

Study Arms (2)

ischemic preconditioning

ACTIVE COMPARATOR

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

control

NO INTERVENTION

no intervention will be done

Interventions

ischemic preconditioningPROCEDURE

) 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 preconditioning

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • adult patient
  • valve replacement surgery
  • ASA grade 2 or 3

You may not qualify if:

  • emergency surgery
  • \- poor general conditions
  • impaired hepatic or renal function
  • peripheral vascular disease
  • patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

Location

MeSH Terms

Interventions

Ischemic Preconditioning

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia and ICU

Study Record Dates

First Submitted

April 2, 2017

First Posted

April 7, 2017

Study Start

March 1, 2016

Primary Completion

February 1, 2017

Study Completion

May 1, 2017

Last Updated

October 30, 2017

Record last verified: 2017-10

Locations

EG(1)