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

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: Dietary Supplement: Enteral Nutrients ( Nutren Optimum, Nutren Diabetes, Novasource Renal ), Parenteral Nutrient ( Smofkabiven)

• Registration Number: NCT04479254
• Lead Sponsor: International Islamic University Malaysia

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2019-09-25
• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-21
• Primary Completion: 2020-08-25
• Study Completion: 2020-09-25
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indirect Calorimetry- Directed Nutrition	Enteral Nutrients ( Nutren Optimum, Nutren Diabetes, Novasource Renal ), Parenteral Nutrient ( Smofkabiven)	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
Standard weight-based equation- Directed Nutrition	Enteral Nutrients ( Nutren Optimum, Nutren Diabetes, Novasource Renal ), Parenteral Nutrient ( Smofkabiven)	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.

Primary Outcome Measures

Name	Time	Method
ICU mortality	28 Days	Rate of mortality from all causes before or at day 28 in the ICU during the same ICU admission

Secondary Outcome Measures

Name	Time	Method
Length of mechanical ventilation	28Days	will be measured as the calendar days between start and end of mechanical ventilation until 28 days
Length hospital stay	28 Days	will be calculated using the admission date and expiration or discharge date from hospital until 28 days
Hospital mortality	28Days	Rate of mortality from all causes (death in ICU or in ward) before or at day 28 during the same hospital admission.
Length of ICU stay	28 Days	will be measured as the number of calendar days between admission and discharge from ICU.or until 28 days
Muscle wasting	First 10 days of ICU admission	define as differences between the serial ultrasound measurement of quadriceps femoris muscle layer thickness (vastus intermedius and rectus femoris) over the first 10 days(on day 1,3,5,7 and 10 ) of ICU Admission.

Trial Locations

Locations (1)

IIUM- Medical Center; 🇲🇾 Kuantan, Pahang, Malaysia