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

Primary Purpose

Critical Illness

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Enteral Nutrients ( Nutren Optimum, Nutren Diabetes, Novasource Renal ), Parenteral Nutrient ( Smofkabiven)
Sponsored by
International Islamic University Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Indirect calorimetry, Energy expenditure, Critical illness

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IIUM- Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Indirect Calorimetry- Directed Nutrition

Standard weight-based equation- Directed Nutrition

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of ICU stay
will be measured as the number of calendar days between admission and discharge from ICU.or until 28 days
Length of mechanical ventilation
will be measured as the calendar days between start and end of mechanical ventilation until 28 days
Length hospital stay
will be calculated using the admission date and expiration or discharge date from hospital until 28 days
Hospital mortality
Rate of mortality from all causes (death in ICU or in ward) before or at day 28 during the same hospital admission.
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.

Full Information

First Posted
July 16, 2020
Last Updated
August 27, 2021
Sponsor
International Islamic University Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT04479254
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 25, 2019 (Actual)
Primary Completion Date
August 25, 2020 (Actual)
Study Completion Date
September 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Islamic University Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Indirect calorimetry, Energy expenditure, Critical illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indirect Calorimetry- Directed Nutrition
Arm Type
Experimental
Arm Description
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
Arm Title
Standard weight-based equation- Directed Nutrition
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Enteral Nutrients ( Nutren Optimum, Nutren Diabetes, Novasource Renal ), Parenteral Nutrient ( Smofkabiven)
Intervention Description
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 Outcome Measure Information:
Title
ICU mortality
Description
Rate of mortality from all causes before or at day 28 in the ICU during the same ICU admission
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
Length of ICU stay
Description
will be measured as the number of calendar days between admission and discharge from ICU.or until 28 days
Time Frame
28 Days
Title
Length of mechanical ventilation
Description
will be measured as the calendar days between start and end of mechanical ventilation until 28 days
Time Frame
28Days
Title
Length hospital stay
Description
will be calculated using the admission date and expiration or discharge date from hospital until 28 days
Time Frame
28 Days
Title
Hospital mortality
Description
Rate of mortality from all causes (death in ICU or in ward) before or at day 28 during the same hospital admission.
Time Frame
28Days
Title
Muscle wasting
Description
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.
Time Frame
First 10 days of ICU admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DR. MOHD BASRI Mat Nor, M.Med (Anesthesiology)
Organizational Affiliation
IIUM University
Official's Role
Principal Investigator
Facility Information:
Facility Name
IIUM- Medical Center
City
Kuantan
State/Province
Pahang
ZIP/Postal Code
25200
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21340655
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.
Results Reference
background
PubMed Identifier
27585532
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.
Results Reference
background

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

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