Ultrasonography for Nutritional Assesment in Cirrhotic Pa... | NCT04099875

Studies
Ultrasonography for Nutritional Assesment in Cirrhotic Patients

NCT04099875

Sponsor

National Liver Institute, Egypt

Status

Unknown status

Last Update Posted

Aug 21, 2020Actual

Enrollment

72Estimated

Phase

Not provided

Conditions

Nutrition Assessment

Interventions

ultrasound

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

Aug 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

Apr 1, 2019Actual

Primary Completion Date

Jul 1, 2020Actual

Completion Date

Apr 1, 2021Estimated

First Submitted Date

Apr 24, 2019

First Submission Date that Met QC Criteria

Sep 20, 2019

First Posted Date

Sep 23, 2019Actual

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

Aug 20, 2020

Last Update Posted Date

Aug 21, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Ultrasonography of Rectus Femoris and Anterior Tibialis muscles for nutritional assesment in cirrhotic patients undergoing major abdominal surgery

Detailed Description

in the study, the investigator will use ultrasound to assess the nutritional state of cirrhotic patients after major abdominal surgery,The investigator aim to assess reliability of ultrasound as a bedside,non invasive tool,The investigator will enroll 72 patients for or study which is an observational study

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

72Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound	Diagnostic Test	Ultrasound is a type of imaging. It uses high-frequency sound waves to look at organs and structures inside the body.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of the diameters of the Rectus Femoris and Anterior Tibialis muscles using the ultrasound in cm and the change of these diameters over the postoperative period till the 7th day to assess nutrition status in cirrhotic patients	observational prospective study	perioperative days 1,3,5,7

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hepatic patients classified as child A, B undergoing major abdominal surgery (liver resection,whipple,Splenectomy,colectomy, Common Bile Duct exploration,By pass surgery)
18-60 yrs old
no past history of nutritional problems,chronic use of drugs,patients with no orthopedic issues such as skeletal fractures or immobilization

Exclusion Criteria:

Refusal of the patient to share in the study, relevant comorbidities (renal, heart disease or COPD)
previous immune abnormalities including treatment with corticosteroids
neuromuscular diseases
laparoscopic surgery
patients on parenteral nutrition

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

cirrhotic patients child A,B

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amany A. Zayd, MBBCH	Contact	01014514573		amany_zayd@yahoo.com
Eman S. Ibrahim, MD	Contact	01016303518		emansayed825@gmail.com

Overall Officials

Name	Affiliation	Role
Amany A. Zayd, MBBCH	Department of Anesthesia NLI	Principal Investigator
Eman S. Ibrahim, MD	National Liver Institute	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Liver Institute	Recruiting	Shibīn al Kawm	Menoufia	2345	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

after completion of the study,we will publish the data on special nutrition Journal

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005355	Fibrosis

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014463	Ultrasonography

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided