Cardiovascular DiseasesNCT06625996
Examining the Effectiveness of Carbohydrate Loading as a Nursing Intervention in Enhanced Recovery After Surgery
A study testing carbohydrate loading in people with Cardiovascular Diseases, run by RAK Medical and Health Sciences University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- carbohydrate loading
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2024to 6 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiovascular disease
Who cannot join
- Insulin dependent diabetes
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut
Ghada Hassan, PhD, +20106679087, Ethical@assiut.edu.eg
About this study
Official title: Examining the Effectiveness of Carbohydrate Loading as a Nursing Intervention in Enhanced Recovery After Surgery: A Comprehensive Analysis of Protocol Compliance and Patient Outcomes
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
- Conditions
- Cardiovascular Diseases
- Being tested
- carbohydrate loading
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbohydrate loadingDietary supplement
Preoperative carbohydrate loading
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | Not described Receives: Dietary Supplement: carbohydrate loading |
| control | Placebo comparator | No intervention Receives: Dietary Supplement: carbohydrate loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay post cardio thoracic surgery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start3 Jan 2024
- Primary completion6 Nov 2025 (estimated)
- Study completion6 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RAK Medical and Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Gamal, RAK Medical and Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625996
- Sponsor's protocol ID
- 3380031
- Status last verified
- Oct 2024
- First submitted
- 30 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effectiveness of Carbohydrate Loading as a Nursing Intervention in Enhanced Recovery After Surgery: A Comprehensive Analysis of Protocol Compliance and Patient Outcomes
- ClinicalTrials.gov ID
- NCT06625996
- Acronym / sponsor ID
- 3380031
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RAK Medical and Health Sciences UniversityUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 6 Nov 2025 (estimated)
- Study completion
- 6 Oct 2026 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Dietary Supplement: carbohydrate loading |
| control | Placebo comparator | Dietary Supplement: carbohydrate loadingNo intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cardiovascular disease
Key exclusion criteria (2 listed)
- Insulin dependent diabetes
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carbohydrate loadingPreoperative carbohydrate loading | Dietary supplement | Study, control |
Primary outcome
Length of hospital stay post cardio thoracic surgery
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carbohydrate loading in people with Cardiovascular Diseases, run by RAK Medical and Health Sciences University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay post cardio thoracic surgery (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.