Comparison of the Effects of Metoclopramide and Erythromycin on Gastric Residual Volume in Critically Ill Patients Receiving Enteral Nutrition in the Intensive Care Unit

Comparison of the effect of metoclopramide versus erythromycin on gastric residual volume in critically ill patients under enteral nutrition admitted to the intensive care unit

A prospective clinical trial conducted on two parallel groups of 30 patients each (total 60 patients) with equal allocation ratio. Randomization was performed to assign patients to each intervention group.

The study was conducted in the ICU of Payambar Azam Educational, Medical and Research Center, Bandar Abbas, in 2016–2017. Gastric residual volume was measured every 6 hours over three days. Blood sodium, potassium, and glucose were assessed at baseline and at 24, 48, and 72 hours after enteral nutrition initiation.

Critically ill patients admitted to the ICU of Payambar Azam Educational, Medical and Research Center under enteral nutrition via nasogastric tube and connected to mechanical ventilator were enrolled. Exclusion criteria included allergy to either drug, active gastrointestinal bleeding, recent abdominal surgery, or death within the first 24 hours.

The first group received metoclopramide and the second received erythromycin as prokinetic agents. Both drugs were administered enterally. All patients received standard ICU care including hemodynamic monitoring, mechanical ventilation, and routine nasogastric enteral nutrition every three hours.

Primary outcome: gastric residual volume and number of patients with gastric reflux over 72 hours. Secondary outcomes: changes in blood sodium, potassium, and glucose levels over 72 hours and comparison between the two groups.

This clinical trial will employ simple randomization with individual participants as the unit of randomization. Eligible patients admitted to the Intensive Care Unit of Shahid Mohammadi Hospital, Bandar Abbas, who meet the inclusion criteria and provide informed consent, will be randomly assigned in a 1:1 ratio to either the subcutaneous heparin group or the intravenous heparin group. The randomization sequence will be generated using Random Allocation Software. Allocation concealment will be maintained through restricted access to the randomization list, separation of research responsibilities, and the use of sealed sequentially numbered envelopes to minimize the risk of selection bias.

This study is designed as a double-blind clinical trial. Patients, treating physicians, ward nurses (except the nurse responsible for drug preparation and administration), and outcome assessors will remain unaware of the intervention type and treatment allocation. Heparin preparation and administration will be performed by a designated nurse who is not involved in data collection or outcome assessment. Study medications will be labeled using coded identifiers, and allocation information will be stored in sealed envelopes. Allocation codes will only be disclosed in emergency situations or after completion of the study and final data analysis. This approach is intended to minimize both performance bias and detection bias.

Still undecided - no release schedule yet.