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

Critical Illness Clinical Trial

Official title:

The Impact of Indirect Calorimetry Guided Medical Feeding Protocol on Clinical Outcomes in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04479254
• Other study ID #: 2019-504/14/11/2
• Status: Completed
• Phase: N/A
• Start date: September 25, 2019
• Est. completion date: September 25, 2020

Study information

• Verified date: August 2021
• Source: International Islamic University Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 25, 2020
• Est. primary completion date: August 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

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

Locations

Country	Name	City	State
Malaysia	IIUM- Medical Center	Kuantan	Pahang

Sponsors (1)

Lead Sponsor	Collaborator
International Islamic University Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (2)

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). pii: A5271. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU mortality	Rate of mortality from all causes before or at day 28 in the ICU during the same ICU admission	28 Days
Secondary	Length of ICU stay	will be measured as the number of calendar days between admission and discharge from ICU.or until 28 days	28 Days
Secondary	Length of mechanical ventilation	will be measured as the calendar days between start and end of mechanical ventilation until 28 days	28Days
Secondary	Length hospital stay	will be calculated using the admission date and expiration or discharge date from hospital until 28 days	28 Days
Secondary	Hospital mortality	Rate of mortality from all causes (death in ICU or in ward) before or at day 28 during the same hospital admission.	28Days
Secondary	Muscle wasting	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.	First 10 days of ICU admission