Effect of Anaesthesia on Basic Aminoacids | NCT04431492

Studies
Effect of Anaesthesia on Basic Aminoacids

NCT04431492

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jul 14, 2020Actual

Enrollment

58Estimated

Phase

Not provided

Conditions

Effect of Anaesthesia on Basic Aminoacids

Interventions

CABG

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 11, 2020Actual

Primary Completion Date

Dec 1, 2020Estimated

Completion Date

Dec 2, 2020Estimated

First Submitted Date

Jun 11, 2020

First Submission Date that Met QC Criteria

Jun 11, 2020

First Posted Date

Jun 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2020

Last Update Posted Date

Jul 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Basic amino acids are acids that contains amino groups more than carboxylic groups. At least five basic amino acids namely; Arginine, citrulline, ornithine, lysine and hydroxylysine metabolize in our body. Loss of body protein represents a typical feature of the catabolic response to surgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

58Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
coronary artery bypass			Procedure: CABG
thoracic surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CABG	Procedure	aminoacids and NO levels	coronary artery bypass

Measure	Description	Time Frame
basic aminoacids and NO levels		72 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective surgery
ASA II,III

Exclusion Criteria:

Emergency surgery
Associated renal or liver disease
Chronic disease as D.M

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

patients undergoing cardiopulmonary bypass and thoracotomy for lung resection secondary to lung carcinoma, three samples will be taken to evaluate the levels of basic amino acids and NO levels

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
saeid elsawy	Contact	01030072161		saeedelsawy17@gmail.com
Ali	Contact	01030072161		rashaahmed7272@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut university	Recruiting	Asyut		71111	Egypt