The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study)

International Islamic University Malaysia

Status: Completed

Conditions: Critical Illness

Treatments: Dietary Supplement: Enteral Nutrients ( Nutren Optimum, Nutren Diabetes, Novasource Renal ), Parenteral Nutrient ( Smofkabiven)

Study type: Interventional

Funder types: Other

Identifiers

NCT04479254

2019-504/14/11/2

Details and patient eligibility

About

Adequate nutritional support is an essential element for achieving favourable outcomes in critically ill patients. Therefore, an accurate determination of patients' energy needs is required to optimize nutritional support and reduce the harmful effects of under- and over-feeding. Currently, indirect calorimetry is considered as a gold standard for measuring energy expenditure during critical illness.

This randomized study aims to investigate the impact of indirect calorimetry guided nutrition therapy on clinical outcomes such as ICU. Mortality, hospital mortality, duration of mechanical ventilation, length of I.C.U./hospital stay and mascle wasting. The investigators hypothesis that nutrition therapy guided by IC will improve clinical outcomes in severely ill patients

Full description

This is a single-blind randomized control study. Eligible participants are randomly assigned within 24 hrs of ICU. admission in two groups

• Intervention group: The calorie needs will be determined by indirect calorimetry.
• Control group: a routine standard weight-based equation (20-25kcal/kg ideal body weight/day) will be used to estimate the energy requirements of critically ill patients.

Daily energy and protein data will be recorded for a maximum of 12 evaluable days (nutritional days) or until death or discharge from ICU.while outcome data will be collected for a maximum of 28 days.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients aged over 18 years old
• Critically ill patients with me ical ventilation
• Expected to have an ICU. stay of more than (3) days

Exclusion criteria

• Requirement for inspired oxygen content (FiO2) greater than 0.6
• Patients on high-frequency ventilation
• Patients with chest tubes that leak air/ Bronchopleural fistula
• Patients with incompetent tracheal cuff
• Patients inhaled nitric oxide therapy
• Patients receiving continuous renal replacement therapy (CRRT) during IC measurement
• Patients with pregnancy
• Patients with burn injury
• Patients infected with human immunodeficiency virus (HIV)
• Patients with severe liver disease (Child-Pugh score C)
• seizure activity
• patients suffering from significant head trauma (GCS <8)
• Patients with paraplegia and quadriplegia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Indirect Calorimetry- Directed Nutrition

Experimental group

Description:

Enteral Nutrition (EN) will be the preferred route of nutrition, and will be initiated within the first 24-48 hours of ICU admission. Caloric requirements will be measured by indirect calorimetry IC as soon as possible after recruitment and will be repeated in every 24 hrs. The amount of delivery is gradually increased to avoid the possibility of gastrointestinal intolerance. If EN fails to reach caloric goals or not feasible supplementary Parenteral nutrition(PN) will be initiated after 5-7days

Treatment:

Dietary Supplement: Enteral Nutrients ( Nutren Optimum, Nutren Diabetes, Novasource Renal ), Parenteral Nutrient ( Smofkabiven)

Standard weight-based equation- Directed Nutrition

Active Comparator group

Description:

Enteral Nutrition (EN) will be initiated within the first 24-48 hours of ICU. Admission. Enteral nutrient delivery is gradually increased to avoid the possibility of gastrointestinal intolerance so that a few days are required to achieve the caloric target. PN will be started after 5-7 days if EN is not feasible. Energy and protein goals will be calculated by the standard weight-based equation of 25 kcal/kg BW body weight and 1.2-2.5 g/kg body weight, respectively.

Treatment:

Dietary Supplement: Enteral Nutrients ( Nutren Optimum, Nutren Diabetes, Novasource Renal ), Parenteral Nutrient ( Smofkabiven)