Examining the Effectiveness of Carbohydrate Loading as a... | NCT06625996

Studies
Examining the Effectiveness of Carbohydrate Loading as a Nursing Intervention in Enhanced Recovery After Surgery

NCT06625996

Sponsor

RAK Medical and Health Sciences University

Status

Recruiting

Last Update Posted

Oct 3, 2024Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Cardiovascular Diseases

Interventions

carbohydrate loading

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

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 3, 2024Actual

Primary Completion Date

Nov 6, 2025Estimated

Completion Date

Oct 6, 2026Estimated

First Submitted Date

Sep 30, 2024

First Submission Date that Met QC Criteria

Oct 2, 2024

First Posted Date

Oct 3, 2024Actual

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

Oct 2, 2024

Last Update Posted Date

Oct 3, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mona Gamal, Assistant Professor, RAK Medical and Health Sciences UniversityPrincipal Investigator

Lead Sponsor

RAK Medical and Health Sciences UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The concept of Enhanced Recovery After Surgery (ERAS) protocols has revolutionized perioperative care by promoting a series of evidence-based practices aimed at reducing surgical stress and improving patient outcomes. Among these practices, preoperative carbohydrate loading has emerged as a significant intervention designed to mitigate the adverse metabolic effects of surgery

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study	Experimental		Dietary Supplement: carbohydrate loading
control	Placebo Comparator	No intervention	Dietary Supplement: carbohydrate loading

Interventions

Name	Type	Description	Arm Group Labels	Other Names
carbohydrate loading	Dietary Supplement	Preoperative carbohydrate loading	Study control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of hospital stay post cardio thoracic surgery		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Cardiovascular disease

Exclusion Criteria:

Insulin dependent diabetes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University	Recruiting	Asyut			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000070601	Diet, Carbohydrate Loading

Ancestor Terms

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D004032	Diet
D009747

Browse Leaves

Not provided

Browse Branches

Not provided