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

NCT04479254 | Completed

• 1 other identifier: 2019-504/14/11/2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Critical Illness

Keywords

Indirect calorimetry, Energy expenditure, Critical illness

Outcome Measures

Primary Outcomes (1)

• ICU mortality

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

  28 Days

Secondary Outcomes (5)

• Length of ICU stay

  28 Days

• Length of mechanical ventilation

  28Days

• Length hospital stay

  28 Days

• Hospital mortality

  28Days

• Muscle wasting

  First 10 days of ICU admission

Study Arms (2)

Indirect Calorimetry- Directed Nutrition

EXPERIMENTAL

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

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

Standard weight-based equation- Directed Nutrition

ACTIVE COMPARATOR

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.

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

Interventions

Enteral Nutrients ( Nutren Optimum, Nutren Diabetes, Novasource Renal ), Parenteral Nutrient ( Smofkabiven) DIETARY_SUPPLEMENT

Enteral nutrition feeding formula is used in powder form and will be reconstituted by attending nurses, Continuous feeding is commonly used which will be prescribed by the attending clinicians, Energy and protein intake from EN will be estimated by multiplying the volume of feed given to energy (kcal) and protein (g) in 1 ml of standard dilution, and for Standard PN product, energy and protein intake will also be calculated based on the volume infused.

Indirect Calorimetry- Directed Nutrition; Standard weight-based equation- Directed Nutrition

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Islamic University Malaysia: lead

Study Sites (1)

IIUM- Medical Center

Kuantan, Pahang, 25200, Malaysia

Location

Related Publications (2)

• 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.

  PMID: 21340655 BACKGROUND

• 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.

  PMID: 27585532 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• DR. MOHD BASRI Mat Nor, M.Med (Anesthesiology)

  IIUM University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate.Professor

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 21, 2020
• Study Start: September 25, 2019
• Primary Completion: August 25, 2020
• Study Completion: September 25, 2020
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

MY (1)