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Effects of Early Oral Diet After Cardiac Surgery: an Open Label Randomized Controlled Trial

NCT06146426 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2024-02-09

No results posted yet for this study

Summary

This is an open label randomized controlled trial with two parallel groups to compare the effects of early initiation of oral diet to reduce the post-operative fasting time in adult patients undergoing cardiac surgery.Primary Objectives:

* To assess the impact of early and conventional diet on post-operative nausea and vomiting by calculating the simplified PONV (post-operative nausea and vomiting) impact score of patients after cardiac surgery, with a score \>5 indicating clinically significant PONV.
* To study the impact of early versus conventional diet on gastrointestinal function by estimating the difference in timing of the first bowel movement in patients following cardiac surgery.

Secondary Objectives:

* To evaluate the effects of early versus conventional diet resumption on length of ICU stay among the patients following cardiac surgery in days.
* To compare the satisfaction levels of patients by visual analogue scale who resumed their oral diets early versus conventionally following cardiac surgery. The estimated sample size of 196 patients with routine post operative recovery after cardiac surgery will be randomized into early (interventional) and late (control) diet groups. Researchers will compare the early diet group with late diet group to see the effects.

Conditions

  • Adult Cardiac Surgery

Interventions

DIETARY_SUPPLEMENT

Early diet resumption

Resuming oral diet at pace started from 2 hours after extubation from ventilator.

Sponsors & Collaborators

  • Hamad Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Siddiha P Shahulhameed · Hamad Medical Corporation

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-12
Primary Completion
2025-12-01
Completion
2025-12-31

Countries

  • Qatar

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06146426 on ClinicalTrials.gov