Clinical Research Directory

Continuous Versus Intermittent Enteral Feeding and Gastric Residual Volume in Critically Ill Patients

This study will compare two commonly used methods of enteral feeding in critically ill adults: continuous feeding and intermittent feeding. The main purpose is to determine whether the amount of feeding fluid remaining in the stomach differs between the two methods. A total of 76 participants will be randomly assigned to receive either continuous gastric feeding or intermittent gastric feeding every 4 hours. Gastric ultrasound will be performed at the bedside before starting the assigned feeding method and then every 4 hours for 72 hours. The study will also record symptoms of feeding intolerance, such as vomiting, regurgitation, abdominal distension, diarrhea, constipation, feeding interruptions, and the amount of prescribed nutrition actually delivered.

Transcutaneous Auricular Stimulation Targeting Enteral Feeding Intolerance

This study will test whether electrical stimulation applied to the outer ear can improve tolerance of tube feeding in critically ill adults in the intensive care unit (ICU). Some ICU patients develop digestive problems, such as vomiting, diarrhea, or a buildup of feeding liquid in the stomach. These problems can prevent them from receiving enough nutrition through a feeding tube. This is called enteral feeding intolerance. The treatment being studied is called transcutaneous auricular vagus nerve stimulation (taVNS). It delivers small electrical pulses through electrodes placed on the skin of the outer ear, usually the left ear. It does not require surgery. The treatment targets a branch of the vagus nerve, which helps regulate digestion. Researchers want to find out whether adding this treatment to usual ICU care improves feeding tolerance and whether it causes side effects. The study will enroll 60 adults aged 18 years or older with enteral feeding intolerance at one hospital. Participants will be assigned by chance to one of two groups, with an equal chance of joining either group: * Usual ICU care alone. * Usual ICU care plus ear stimulation for 60 minutes once daily for five days. Stimulation will stop earlier if a participant leaves the ICU or the study team determines that it should be stopped for safety reasons. The main measure will be the proportion of participants whose feeding intolerance improves between 24 and 120 hours after enrollment. Improvement means receiving the study's target amount of calories through tube feeding for at least 48 consecutive hours without stopping feeding because of intolerance. Researchers will also collect blood samples and rectal swabs to study intestinal function, gut bacteria, and substances produced by the body and gut bacteria. They will record the use of pain medicines and sedatives, changes in illness severity, and possible side effects, including skin irritation, a slow heartbeat, or low blood pressure. Study assessments and sample collection in the ICU will continue for up to seven days after enrollment, ending earlier if the participant leaves the ICU. Follow-up at 28 and 90 days will assess survival and, at 90 days, new infections and hospital readmissions.

Exclusive Enteral Nutrition in Preterm Neonates

To test the hypothesis that early exclusive enteral nutrition with the minimal use of parenteral nutrition will improve preterm infants' nutritional outcomes when compared to delayed progression of enteral nutrition and prolonged use of parenteral nutrition.

Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants

In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early protein supplementation through early fortification results in higher FFM-for-age z scores and more diversity in the gut microbiome.

Effect of Semi-elemental Enteral Nutrition on Gastrointestinal Tolerance in Patients With Traumatic Brain Injury.

Study Objective This clinical trial primarily aims to investigate whether semi-elemental enteral nutrition (SEN) improves gastrointestinal tolerance in patients with severe traumatic brain injury (TBI) and to evaluate its impact on clinical outcomes. The safety profile of SEN will also be assessed. Key Research Questions Does SEN reduce the incidence of acute gastrointestinal injury (AGI) in severe TBI patients? Study Design Participants will be randomized 1:1 into either: Intervention group: Receives SEN initiated within 48 hours post-injury and continued for ≥7 days. Control group: Receives standard enteral nutrition over the same period.

Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology

Blenderized diets consist of a wide range of table foods such as fruits, vegetables, meat and legumes, pureed in a blender and administered via gastrostomy tube. In a recent study, the investigators reported that children receiving blenderized feeds via gastrostomy had fewer total admissions and respiratory admissions, total emergency room visits, and improved gastrointestinal symptom scores compared to those fed formula. The goal of this project is to understand how these diets affect gastroesophageal reflux burden.

Undiluted and Diluted Nutrition

Adult patients after elective major abdominal surgeries who are planned to be admitted to the Intensive Care Unit (ICU) can be included in the trial. Each patient will be fed via the gastrointestinal tract. Half of the patients will receive enteral nutrition (EN) with additional fluids, and the rest will receive undiluted EN. The primary aim of this study is to assess feeding intolerance in both patient groups.

Bedside Observation by Clinical Ultrasound for Stomach Expansion

The objective of the BOCUSE study is to demonstrate a relationship between an early ultrasound measurement of the gastric antral area and the subsequent occurrence of poor gastric tolerance.

A Comparative Evaluation of Mosapride Versus Metoclopramide for Enteral Feeding Intolerance in Critically Ill Patients

Caring for critically ill patients in an intensive care unit (ICU) is considered a standard of care. According to the Society of Critical Care Medicine (SCCM), as a function of the complex nature of the care provided in the ICU, the ideal method to provide support to the critically ill involves the participation of a multi-professional staff. Provision of nutrition support to the critically ill is now established as an essential part of patient care where aiming toward 100% of the predicted target may have resulted in reduced mortality and increased ventilator-free days in those who are premorbid malnourished. Despite these reported benefits, clinicians continue to deliver little more than half of the enteral nutrition (EN) they plan to provide, due to gastric motility disorders, patient intolerance and clinical interruptions. Also despite the availability of numerous clinical practice guidelines (CPGs) focused on feeding critically ill patients, observational studies have consistently demonstrated persistent and significant gaps between guideline recommendations and actual nutrition practice. Consequently, underfeeding is prevalent in the intensive care unit (ICU), with patients on average receiving only 60 % of the calories that are prescribed. Moreover, Among the barriers to adequate nutritional supply in the ICU which contributes to nutritional status deterioration, gastrointestinal disorders causing enteral feed intolerance are the most important and the most often mentioned in the literature. when gastric emptying was measured in critically ill patients, 46 % of them had evidence of delayed gastric emptying. Untreated slow gastric emptying has a plethora of clinical consequences such as vomiting, aspiration of gastric contents, pneumonia, and contributes significantly to the frequent interruptions and cessation of EN in the ICU, which results in inadequate nutritional delivery. Studies have shown an association between feeding intolerance, prolonged intensive care unit (ICU) stay, and increased risk of death. Guidelines for the provision and assessment of nutrition support therapy in the adult critically ill patients has demonstrated the importance of the use of prokinetic drugs to improve tolerance to gastric feeding in critically ill patients and achieve earlier discharge. Prokinetic drugs act by promoting gastric motility, increase gastric emptying, prevent the retention and reflux of gastric contents and thus provide symptomatic relief. Most of the prokinetic drugs are efficacious with prokinetic activity but the matter of major concern is their side effect profile. The most commonly used agent is metoclopramide. Although it is the most commonly used prokinetic to treat delayed gastric emptying and facilitate early enteral feeding, adverse complications limit its use including tachyphylaxis, tardive dyskinesia on long term use and QT prolongation predisposing to cardiac arrhythmias. Several drug targets have been identified to develop new promotility agents and several new medications are under investigation to overcome the side effects caused by most of the prokinetics . Mosapride is another available prokinetic agent that enhances gastric motility through serotonin receptor agonism; resulting in prokinetic effects. It accelerates gastric emptying, improves gastric tension and sensitivity, and has anti-emetic action. The aim of the current study is to compare the effectiveness as well as the safety of Mosapride against metoclopramide as the first line treatment for feeding intolerance in critically ill patients.

Diluted and Undiluted Enteral Nutrition

Adult patients after elective major abdominal surgeries who are planned to be admitted to the Intensive Care Unit (ICU) can be included in the trial. Each patient will be fed via the gastrointestinal tract. Half of the patients will receive enteral nutrition (EN) with additional fluids, and the rest will receive undiluted EN. The primary aim of this study is feeding intolerance assessment in both groups of patients.

Gastrointestinal Dysfunction in Aortic Surgery Patients

The goal of this observational study is to determine the association of gastrointestinal dysfunction through the Gastrointestinal Dysfunction Scale (GIDS) tool and serum concentrations of citrulline and Intestinal fatty-acid binding protein (I-FABP) with primary \[calories received, protein received, parenteral nutrition requirement and 28-day mortality in the intensive care unit (ICU)\] and secondary (development of pneumonia, surgical and cardiovascular complications in the ICU, length of hospital and ICU stay, duration of mechanical ventilation) clinical outcomes in critically ill patients undergoing aortic surgery.