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NCT Number: NCT04479254

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

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

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IIUM- Medical Center

Kuantan, Pahang, 25200, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. ICU mortality

    Time frame: 28 Days

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

Secondary outcomes

  1. Length of ICU stay

    Time frame: 28 Days

    will be measured as the number of calendar days between admission and discharge from ICU.or until 28 days

  2. Length of mechanical ventilation

    Time frame: 28Days

    will be measured as the calendar days between start and end of mechanical ventilation until 28 days

  3. Length hospital stay

    Time frame: 28 Days

    will be calculated using the admission date and expiration or discharge date from hospital until 28 days

  4. Hospital mortality

    Time frame: 28Days

    Rate of mortality from all causes (death in ICU or in ward) before or at day 28 during the same hospital admission.

  5. Muscle wasting

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

International Islamic University Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 21, 2020
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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