Critically IllNCT03060668
Optimized Caloric-proteic Nutrition in Critically Ill Patients
A study testing Peptamen intense and Novasource senior in people with Critically Ill, run by Hospital Sao Domingos at 1 site in Brazil.
Trial summary
In this prospective randomized controlled trial the investigators intend to compare the use of a nutritional therapy based on caloric intake determined by indirect calorimetry and a high protein intake (2.0 to 2.2 g/kg/day) with a nutritional regimen based on 25 Kcal/kg/day and protein intake usually recommended to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- Peptamen intense and Novasource senior
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2016to Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critically ill patients Mechanically ventilated Expected length in the ICU > 3 days
Who cannot join
- Pregnancy Requirement for inspired oxygen (FIO2) > 0.60 High output bronchopleural fistula
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimized Caloric-proteic Nutrition in Critically Ill Patients: Impact on Short and Long-term Outcomes
In this prospective randomized controlled trial the investigators intend to compare the use of a nutritional therapy based on caloric intake determined by indirect calorimetry and a high protein intake (2.0 to 2.2 g/kg/day) with a nutritional regimen based on 25 Kcal/kg/day and protein intake usually recommended to critically ill patients (1.4 to 1.5 grams/kg/day).
Read the detailed description
OBJECTIVES
To evaluate the effect of nutritional therapy with caloric intake determined by indirect calorimetry and high protein intake (2.0 to 2.2 g/kg/day) compared to nutritional therapy with 25 kcal/kg/day and 1.4 to 1, 5 g/kg/day of protein on short-term outcomes and physical component (PCS) of quality of life after 3 and 6 months of randomization in severe ICU patients.
The primary objective will be the evaluation of the physical component summary (PCS) of SF-36 (Short Form 36), a questionnaire used to evaluate quality of life, validated for the Brazilian population. Patients will be assessed at least 3 and 6 months after randomization.
Secondary objectives: Measurement of handgrip strength measured on the 7th and 14th day of the study and on discharge from the ICU, ICU mortality, hospital mortality, mechanical ventilation time and length of stay in the ICU.
METHODS
The study will include patients over 18 years of age, not pregnant, submitted to mechanical ventilation, whose expectation of stay in the ICU is greater than 3 days.
The sample size was calculated based on the following parameters: patient population under mechanical ventilation, 528, 15% relative risk reduction in the evaluation parameter of the SF-36 tool, Level of significance (α) of 5%, test power of 80%, thus the number of individuals to be sampled will be 294, i.e., two groups of 147 patients. A computer-generated list for randomization and sequentially numbered opaque sealed envelopes is used. The level of significance to reject the null hypothesis will be 5%, that is, a value of p <0.05 will be considered as statistically significant.
Informed consent was obtained from the patient or a next of kin.
- Conditions
- Critically Ill
- Being tested
- Peptamen intense, Novasource senior
- Keywords
- Critical Illness, Indirect Calorimetry, Dietary Proteins
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptamen intenseOther
Study group will receive a nutritional formula containing 1.0 kcal/ml and 93 g/L of protein
Novasource seniorOther
Control group will receive a nutritional formula containing 1.2 kcal/ml and 65 g/L of protein
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Caloric needs will be determined by indirect calorimetry. Patients in this group will receive 2.0 to 2.2 grams/kg/day of protein.
Nutritional therapy will be initiated in the first 24 hours after admission.
Nutritional formula will be Peptamen Intense (1.0 kcal/ml, 93 g/L protein (Nestle Health Care). Receives: Other: Peptamen intense |
| Control Group | Active comparator | Patients in this group will receive 25 Kcal/kg/day and 1.4 to 1.5 grams/kg/day of protein.
Nutritional formula in this group will be Novasource senior (Nestle Health Care).
Nutritional therapy will be initiated in the first 24 hours after admission. Receives: Other: Novasource senior |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCS of SF-36
Physical component summary of Short Form 36
Measured: 6 months after randomization
Secondary outcomes (3)
Handgrip strength
Measured using a calibrated dynamometer
Measured: 7th, 14th after admission and up to 30 days
ICU mortality
ICU outcome
Measured: Up to 30 days
Hospital mortality
Hospital outcome
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startJun 2016
- Primary completionMay 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Domingos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Raimundo Araujo de Azevedo, Hospital Sao Domingos
- Investigators
- JOSE R AZEVEDO, PhD, Principal investigator, Hospital Sao Domingos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060668
- Sponsor's protocol ID
- HSaoDomingos
- Status last verified
- Feb 2017
- First submitted
- 11 Feb 2017
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Caloric-proteic Nutrition in Critically Ill Patients: Impact on Short and Long-term Outcomes
- ClinicalTrials.gov ID
- NCT03060668
- Acronym / sponsor ID
- HSaoDomingos
- Conditions
- Critically Ill
- Keywords
- Critical Illness, Indirect Calorimetry, Dietary Proteins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Hospital Sao DomingosUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 23 Feb 2017 (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.
In this prospective randomized controlled trial the investigators intend to compare the use of a nutritional therapy based on caloric intake determined by indirect calorimetry and a high protein intake (2.0 to 2.2 g/kg/day) with a nutritional regimen based on 25 Kcal/kg/day and protein intake usually recommended to critically ill patients (1.4 to 1.5 grams/kg/day).
Detailed description
OBJECTIVES
To evaluate the effect of nutritional therapy with caloric intake determined by indirect calorimetry and high protein intake (2.0 to 2.2 g/kg/day) compared to nutritional therapy with 25 kcal/kg/day and 1.4 to 1, 5 g/kg/day of protein on short-term outcomes and physical component (PCS) of quality of life after 3 and 6 months of randomization in severe ICU patients.
The primary objective will be the evaluation of the physical component summary (PCS) of SF-36 (Short Form 36), a questionnaire used to evaluate quality of life, validated for the Brazilian population. Patients will be assessed at least 3 and 6 months after randomization.
Secondary objectives: Measurement of handgrip strength measured on the 7th and 14th day of the study and on discharge from the ICU, ICU mortality, hospital mortality, mechanical ventilation time and length of stay in the ICU.
METHODS
The study will include patients over 18 years of age, not pregnant, submitted to mechanical ventilation, whose expectation of stay in the ICU is greater than 3 days.
The sample size was calculated based on the following parameters: patient population under mechanical ventilation, 528, 15% relative risk reduction in the evaluation parameter of the SF-36 tool, Level of significance (α) of 5%, test power of 80%, thus the number of individuals to be sampled will be 294, i.e., two groups of 147 patients. A computer-generated list for randomization and sequentially numbered opaque sealed envelopes is used. The level of significance to reject the null hypothesis will be 5%, that is, a value of p <0.05 will be considered as statistically significant.
Informed consent was obtained from the patient or a next of kin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Peptamen intenseCaloric needs will be determined by indirect calorimetry. Patients in this group will receive 2.0 to 2.2 grams/kg/day of protein. Nutritional therapy will be initiated in the first 24 hours after admission. Nutritional formula will be Peptamen Intense (1.0 kcal/ml, 93 g/L protein (Nestle Health Care). |
| Control Group | Active comparator | Other: Novasource seniorPatients in this group will receive 25 Kcal/kg/day and 1.4 to 1.5 grams/kg/day of protein. Nutritional formula in this group will be Novasource senior (Nestle Health Care). Nutritional therapy will be initiated in the first 24 hours after admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Critically ill patients Mechanically ventilated Expected length in the ICU > 3 days
Key exclusion criteria (1 listed)
- Pregnancy Requirement for inspired oxygen (FIO2) > 0.60 High output bronchopleural fistula
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 |
|---|---|---|
| Peptamen intenseStudy group will receive a nutritional formula containing 1.0 kcal/ml and 93 g/L of protein | Other | Study Group |
| Novasource seniorControl group will receive a nutritional formula containing 1.2 kcal/ml and 65 g/L of protein | Other | Control Group |
Primary outcome
PCS of SF-36
Time frame: 6 months after randomization
Physical component summary of Short Form 36
3 secondary outcomes
Handgrip strength
Time frame: 7th, 14th after admission and up to 30 days
ICU mortality
Time frame: Up to 30 days
Hospital mortality
Time frame: Up to 6 months
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 16 Mar 2022.
- Individual participant dataSharing planned: No
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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.
JOSE R AZEVEDO, PhD principal investigator
Hospital Sao Domingos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peptamen intense and Novasource senior in people with Critically Ill, run by Hospital Sao Domingos at 1 site in Brazil.
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 1 inclusion and 1 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 16 Mar 2022. 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 Brazil. 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?
PCS of SF-36 (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2022; AzTrials last refreshed its copy on 2 Nov 2026.