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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03097692
Other study ID # IRB00009909
Secondary ID
Status Completed
Phase N/A
First received March 21, 2017
Last updated December 20, 2017
Start date May 2016
Est. completion date March 2017

Study information

Verified date December 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

An association between white blood cell count (WBC), neutrophil-lymphocyte ratio , and inflammatory process is well known . Ischemic preconditioning reduces the inflammation


Description:

Preliminary evidence has suggested the role of inflammation in development and prognosis of cardiovascular diseases and cancers. Most of the prognostic studies failed to account for the effects of co-morbid conditions as these might have raised the systemic inflammation. We used neutrophil lymphocyte ratio (NLR) as a measure of systemic inflammation and investigated its association with cardiac preconditioning in open heart surgery .


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date March 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- 18-60 years old

- American Society of Anesthesiologists physical status II and III

- Patients scheduled for open heart surgery

- no active inflammatory process

Exclusion Criteria:Exclusion Criteria:

- 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

Study Design


Intervention

Procedure:
ischemic preconditioning
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
Drug:
Pharmacologic preconditionig
Pharmacologic preconditionig will be attained by sevoflurane anesthesia

Locations

Country Name City State
Egypt Emad Zarief Kamel Said Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary change of Neutrophil lymphocyte ratio during first two postoperative days
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