Clinical trial NCT04479254: The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study)
Official title: The Impact of Indirect Calorimetry Guided Medical Feeding Protocol on Clinical Outcomes in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: Indirect calorimetry, Energy expenditure, Critical illness
Lead sponsor: International Islamic University Malaysia
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: ICU mortality
timeFrame: 28 Days
Secondary outcomes:
measure: Length of ICU stay
timeFrame: 28 Days
measure: Length of mechanical ventilation
timeFrame: 28Days
measure: Length hospital stay
timeFrame: 28 Days
measure: Hospital mortality
timeFrame: 28Days
measure: Muscle wasting
timeFrame: First 10 days of ICU admission
Other outcomes:
Locations:
city: Kuantan
country: Malaysia
facility: IIUM- Medical Center
state: Pahang
Study officials:
affiliation: IIUM University
name: DR. MOHD BASRI Mat Nor, M.Med (Anesthesiology)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singer P, Anbar R, Cohen J, Shapiro H, Shalita-Chesner M, Lev S, Grozovski E, Theilla M, Frishman S, Madar Z. The tight calorie control study (TICACOS): a prospective, randomized, controlled pilot study of nutritional support in critically ill patients. Intensive Care Med. 2011 Apr;37(4):601-9. doi: 10.1007/s00134-011-2146-z. Epub 2011 Feb 22.
citation: Allingstrup MJ, Kondrup J, Wiis J, Claudius C, Pedersen UG, Hein-Rasmussen R, Jensen TH, Lange T, Perner A. Early goal-directed nutrition in ICU patients (EAT-ICU): protocol for a randomised trial. Dan Med J. 2016 Sep;63(9):A5271.