Comparing early versus conventional oral diet after cardiac surgery
Effects of Early Oral Diet After Cardiac Surgery: an Open Label Randomized Controlled Trial
This study tests if starting a regular diet sooner after heart surgery helps patients feel better and recover faster compared to waiting longer to eat.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 196 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hamad Medical Corporation Industry-sponsored |
| Locations | 1 site (Doha) |
| Trial ID | NCT06146426 on ClinicalTrials.gov |
What this trial studies
This open label randomized controlled trial aims to evaluate the effects of early initiation of an oral diet compared to a conventional diet in adult patients following cardiac surgery. The study will assess the impact on post-operative nausea and vomiting, gastrointestinal function, length of ICU stay, and patient satisfaction. Participants will be randomly assigned to either the early diet group or the conventional diet group after meeting specific inclusion criteria. The trial will involve monitoring patients for various outcomes, including the timing of their first bowel movement and their experience of nausea and vomiting.
Who should consider this trial
Good fit: Ideal candidates are adult patients who are post-operative from cardiac surgery, extubated, and able to pass a water swallow test.
Not a fit: Patients undergoing major complicated cardiac surgeries or those with cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery times and reduced complications for patients after cardiac surgery.
How similar studies have performed: Other studies have shown promising results with early feeding protocols in post-operative care, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients' post-operative status, * Post extubation (usually extubated within 4-6 hours after surgery) without any cognitive deficits, expected * Minimal chest drain (\<100 ml/h), with * Awake, alert, oriented without any cognitive impairment * Able to pass water swallow test will be included in the study. Exclusion Criteria * Major complicated cardiac surgeries (aortic dissection, surgeries involving mechanical circulatory support (ECMO or Ventricular assist devices). * Patients with profuse surgical /chest drain bleeding \>100 ml/h for 3 consecutive hours in chest drain, * Patients undergo re-exploration sternotomy, cardiac tamponade and * Patients with cognitive impairment, drowsy * Absence of vocalization after extubation * Patients who fails in water swallow test for dysphagia after extubation
Where this trial is running
Doha
- Heart Hospital — Doha, Qatar (Recruiting)
Study contacts
- Principal investigator: Siddiha P Shahulhameed — Hamad Medical Corporation
- Study coordinator: Siddiha P Shahulhameed
- Email: sshahulhameed@hamad.qa
- Phone: +97431441488
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.