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IRCT20240929063203N8 IRCT 2026-06-20 Bandare-abbas University of Medical Sciences 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 Effects of Metoclopramide and Erythromycin on Gastric Residual Volume in Critically Ill Patients Receiving Enteral Nutrition in the Intensive Care Unit 2026-06-20 anticipated 106 Recruiting https://irct.ir/trial/90977 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Delayed gastric emptying and gastric residual volume in critically ill patients under enteral nutrition. Intervention 1: Intervention group: Critically ill patients admitted to the ICU received metoclopramide enterally via nasogastric tube as a prokinetic agent to reduce gastric residual volume; administration began on the day of enteral nutrition initiation and continued for three consecutive days. Intervention 2: Intervention group: Critically ill patients admitted to the ICU received erythromycin enterally via nasogastric tube as a prokinetic agent to reduce gastric residual volume; administration began on the day of enteral nutrition initiation and continued for three consecutive days. No - There is not a plan to make this available Justification or reason for not sharing IPD is Still undecided - no release schedule yet.
public Mehrdad Malekshoar
Next to Recovery, 5-story building, first floor, Shahid Mohammadi Hospital, Islamic Republic Blvd., Bandar Abbas
Bandar Abbas Iran (Islamic Republic of) 7919915519 +98 76 3334 5009 mdmalekshoar@yahoo.com Bandare-abbas University of Medical Sciences scientific Mehrdad Malekshoar
Next to Recovery, 5-story building, first floor, Shahid Mohammadi Hospital, Islamic Republic Blvd., Bandar Abbas
Bandar Abbas Iran (Islamic Republic of) 7919915519 +98 76 3334 5009 mdmalekshoar@yahoo.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Individuals aged 18–70 years admitted to the intensive care unit Use of vasopressors Presence of a central venous catheter Receipt of platelet transfusion History of venous thromboembolism 18 years 70 years Both Development of heparin-induced thrombocytopenia after treatment initiation Occurrence of surgical-site bleeding or intracranial hemorrhage (including epidural hematoma, subdural hematoma, intracerebral hemorrhage, or hemorrhagic stroke) Requirement for surgery during the study period; in such cases, heparin will be discontinued 6 hours before surgery and the patient will be withdrawn from the study K31.8 Other specified diseases of stomach and duodenum Treatment - Drugs Treatment - Drugs Intervention group: Critically ill patients admitted to the ICU received metoclopramide enterally via nasogastric tube as a prokinetic agent to reduce gastric residual volume; administration began on the day of enteral nutrition initiation and continued for three consecutive days. Intervention group: Critically ill patients admitted to the ICU received erythromycin enterally via nasogastric tube as a prokinetic agent to reduce gastric residual volume; administration began on the day of enteral nutrition initiation and continued for three consecutive days. Gastric residual volume and occurrence of gastric content reflux in critically ill patients under enteral nutrition. Timepoint: Every 6 hours over three consecutive days (at hours 6, 12, 18, and 24 of days 1, 2, and 3) after initiation of enteral nutrition. Method of measurement: Aspiration of gastric contents via nasogastric tube before each feeding session; volume measured in milliliters. Reflux was defined as gastric residual volume exceeding the defined threshold. Changes in blood sodium level during 72 hours after enteral nutrition initiation. Timepoint: Baseline (before enteral nutrition), and at 24, 48, and 72 hours after initiation. Method of measurement: Laboratory measurement of serum sodium from a venous blood sample; unit: mEq/L. Changes in blood potassium level during 72 hours after enteral nutrition initiation. Timepoint: Baseline (before enteral nutrition), and at 24, 48, and 72 hours after initiation. Method of measurement: Laboratory measurement of serum potassium from a venous blood sample; unit: mEq/L. Changes in blood glucose level during 72 hours after enteral nutrition initiation. Timepoint: Baseline (before enteral nutrition), and at 24, 48, and 72 hours after initiation. Method of measurement: Laboratory measurement of blood glucose from a venous blood sample; unit: mg/dL. Occurrence of aspiration pneumonia during intensive care unit hospitalization. Timepoint: From admission to discharge from the intensive care unit. Method of measurement: Clinical evaluation by the attending physician and review of medical records based on standard diagnostic criteria for aspiration pneumonia. Mortality during intensive care unit hospitalization. Timepoint: From admission to discharge from the intensive care unit. Method of measurement: Assessment of survival status through medical records during intensive care unit hospitalization. Length of intensive care unit stay. Timepoint: At discharge from the intensive care unit. Method of measurement: Calculation of the duration of intensive care unit hospitalization based on medical records; unit: days. Bandare-abbas University of Medical Sciences Approved 2019-01-06 Research Ethics Committees of Hormozgan University of Medical Sciences Shahid Chamran Boulevard, University of Medical Sciences and Health Services, Bandar Abbas. Bandar Abbas Hormozgan Iran (Islamic Republic of)