SepsisPhase 4NCT02731144
Optimized Caloric-proteic Nutrition in Septic and Septic Shock Patients
A Phase 4 study testing Peptamen intense and Novasource senior in people with Sepsis and Septic Shock, run by Hospital Sao Domingos.
Trial summary
In this pilot randomized prospective controlled trial the investigators intend to compare the use of a nutritional therapy based on caloric intake determined by indirect calorimetry and high protein intake with nutritional regimen based on 25 Kcal / kg / day and protein intake usually recommended for critically ill… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- Peptamen intense and Novasource senior
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Feb 2018
- Phase
- Phase 4
- 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
- Patients admitted to the ICU with sepsis and septic shock according to 3rd International Sepsis Consensus Conference Definitions for sepsis and septic shock
- Mechanically ventilated
- Expected length of stay in ICU ≥ 4 days
- Written informed consent obtained from authorized surrogates
Who cannot join
- Pregnancy
- Requirement for inspired oxygen content (FIO2) > 0.60
- High output bronchopleural fistula
About this study
Official title: The Impact of Optimized Caloric-proteic Nutrition on Clinical Outcome and Physical Component Summary (PCS) of Quality of Life in Septic and Septic Shock Patients
In this pilot randomized prospective controlled trial the investigators intend to compare the use of a nutritional therapy based on caloric intake determined by indirect calorimetry and high protein intake with nutritional regimen based on 25 Kcal / kg / day and protein intake usually recommended for critically ill patients (1.4 to 1.5 grams / kg / day of protein).
- Conditions
- Sepsis, Septic Shock
- Being tested
- Peptamen intense, Novasource senior
- Keywords
- Loss of Physical Function
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptamen intenseOther
Novasource seniorOther
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Individualization of caloric administration with indirect calorimetry and 2.0 to 2.2 g/kg/day of protein. Early initiation of nutritional support (24 hours of admission) Receives: Other: Peptamen intense |
| Control group | Active comparator | Nutritional support initiated in the first 24 hours of admission. Protein and caloric goals calculated as 25 Kcal/kg/day and 1.4 to 1.5 g/kg/day of protein. Receives: Other: Novasource senior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function measured through the tool Physical Component Summary - PCS of Short Form 36
Measured: Three months after randomization
Secondary outcomes (2)
Hospital mortality
Measured: Up to 1 year
Length of ICU stay
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2017
- Study completionFeb 2018
Why it stopped: The protocol was modified substantially and will be resubmitted to Clinical Trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 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, COORDINATOR ICU HOSPITAL SAO DOMINGOS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731144
- Sponsor's protocol ID
- CEP-HSD 33/2016
- Status last verified
- Jan 2018
- First submitted
- 31 Mar 2016
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Optimized Caloric-proteic Nutrition on Clinical Outcome and Physical Component Summary (PCS) of Quality of Life in Septic and Septic Shock Patients
- ClinicalTrials.gov ID
- NCT02731144
- Acronym / sponsor ID
- CEP-HSD 33/2016
- Conditions
- Sepsis, Septic Shock
- Keywords
- Loss of Physical Function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The protocol was modified substantially and will be resubmitted to Clinical Trial
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospital Sao DomingosUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 7 Apr 2016 (estimated)
- 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 pilot randomized prospective controlled trial the investigators intend to compare the use of a nutritional therapy based on caloric intake determined by indirect calorimetry and high protein intake with nutritional regimen based on 25 Kcal / kg / day and protein intake usually recommended for critically ill patients (1.4 to 1.5 grams / kg / day of protein).
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 intenseIndividualization of caloric administration with indirect calorimetry and 2.0 to 2.2 g/kg/day of protein. Early initiation of nutritional support (24 hours of admission) |
| Control group | Active comparator | Other: Novasource seniorNutritional support initiated in the first 24 hours of admission. Protein and caloric goals calculated as 25 Kcal/kg/day and 1.4 to 1.5 g/kg/day of protein. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients admitted to the ICU with sepsis and septic shock according to 3rd International Sepsis Consensus Conference Definitions for sepsis and septic shock
- Mechanically ventilated
- Expected length of stay in ICU ≥ 4 days
- Written informed consent obtained from authorized surrogates
Key exclusion criteria (3 listed)
- Pregnancy
- Requirement for inspired oxygen content (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 intense | Other | Study group |
| Novasource senior | Other | Control group |
Primary outcome
Physical function measured through the tool Physical Component Summary - PCS of Short Form 36
Time frame: Three months after randomization
2 secondary outcomes
Hospital mortality
Time frame: Up to 1 year
Length of ICU stay
Time frame: Up to 1 year
Results and safety
The study was stopped early (reason given: The protocol was modified substantially and will be resubmitted to Clinical Trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: Yes
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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
COORDINATOR ICU HOSPITAL SAO DOMINGOS
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Peptamen intense and Novasource senior in people with Sepsis and Septic Shock, run by Hospital Sao Domingos.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The protocol was modified substantially and will be resubmitted to Clinical Trial). Results are not available in the source record.
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?
Physical function measured through the tool Physical Component Summary - PCS of Short Form 36 (time frame: Three 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 29 Mar 2022.