Critical IllnessNCT04479254
The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study)
A study testing Enteral Nutrients ( Nutren Optimum, Nutren Diabetes, Novasource Renal ), Parenteral Nutrient ( Smofkabiven) in people with Critical Illness, run by International Islamic University Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Enteral Nutrients ( Nutren Optimum, Nutren Diabetes, Novasource Renal ), Parenteral Nutrient ( Smofkabiven)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 25 Sep 2019to 25 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Indirect Calorimetry Guided Medical Feeding Protocol on Clinical Outcomes in Critically Ill Patients
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
Read the 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.
- Conditions
- Critical Illness
- Being tested
- Enteral Nutrients ( Nutren Optimum, Nutren Diabetes, Novasource Renal ), Parenteral Nutrient ( Smofkabiven)
- Keywords
- Indirect calorimetry, Energy expenditure, Critical illness
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Dietary Supplement: Enteral Nutrients ( Nutren Optimum, Nutren Diabetes, Novasource Renal ), Parenteral Nutrient ( Smofkabiven) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
Rate of mortality from all causes before or at day 28 in the ICU during the same ICU admission
Measured: 28 Days
Secondary outcomes (5)
Length of ICU stay
will be measured as the number of calendar days between admission and discharge from ICU.or until 28 days
Measured: 28 Days
Length of mechanical ventilation
will be measured as the calendar days between start and end of mechanical ventilation until 28 days
Measured: 28Days
Length hospital stay
will be calculated using the admission date and expiration or discharge date from hospital until 28 days
Measured: 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.
Measured: 28Days
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.
Measured: First 10 days of ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start25 Sep 2019
- Primary completion25 Aug 2020
- Study completion25 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Islamic University Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohd Basri Mat Nor, International Islamic University Malaysia
- Investigators
- DR. MOHD BASRI Mat Nor, M.Med (Anesthesiology), Principal investigator, IIUM University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479254
- Sponsor's protocol ID
- 2019-504/14/11/2
- Status last verified
- Aug 2021
- First submitted
- 16 Jul 2020
- Last updated
- 30 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21340655Allingstrup 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.
PubMed 27585532
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Indirect Calorimetry Guided Medical Feeding Protocol on Clinical Outcomes in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT04479254
- Acronym / sponsor ID
- 2019-504/14/11/2
- Conditions
- Critical Illness
- Keywords
- Indirect calorimetry, Energy expenditure, Critical illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- International Islamic University MalaysiaUniversity, hospital or other
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 25 Aug 2020 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indirect Calorimetry- Directed Nutrition | Experimental | Dietary Supplement: Enteral Nutrients ( Nutren Optimum, Nutren Diabetes, Novasource Renal ), Parenteral Nutrient ( Smofkabiven)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 |
| Standard weight-based equation- Directed Nutrition | Active comparator | Dietary Supplement: Enteral Nutrients ( Nutren Optimum, Nutren Diabetes, Novasource Renal ), Parenteral Nutrient ( Smofkabiven)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Indirect Calorimetry- Directed Nutrition, Standard weight-based equation- Directed Nutrition |
Primary outcome
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
5 secondary outcomes
Length of ICU stay
Time frame: 28 Days
Length of mechanical ventilation
Time frame: 28Days
Length hospital stay
Time frame: 28 Days
Hospital mortality
Time frame: 28Days
Muscle wasting
Time frame: First 10 days of ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Background: PubMed 21340655Singer 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.
- Background: PubMed 27585532Allingstrup 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DR. MOHD BASRI Mat Nor, M.Med (Anesthesiology) principal investigator
IIUM University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral Nutrients ( Nutren Optimum, Nutren Diabetes, Novasource Renal ), Parenteral Nutrient ( Smofkabiven) in people with Critical Illness, run by International Islamic University Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU mortality (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04479254, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.