Critically IllNCT01142570
Effect of Enteral Nutrition Enriched in Protein and Based on Indirect Calorimetry Measurement in Chronically Critically Ill Patients
A study testing Caloric Support (Group 1), Caloric Support (Group 2) and Protein dose of 1.1 to 1.5 grams per kilogram weight. in people with Critically Ill, run by Rabin Medical Center.
Trial summary
This is a single-center, prospective, randomized, comparative, double-blind controlled clinical study intended to establish 1) the optimal method of determining calorie requirements and 2) the optimal amount of protein supply in chronically ventilated patients. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Critically Ill
- What is being tested?
- Caloric Support (Group 1), Caloric Support (Group 2) and Protein dose of 1.1 to 1.5 grams per kilogram weight.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Nov 2012
- 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Chronically Mechanical Ventilated Patients (more than 21 days of Mechanical Ventilation) by tracheostomy,
- Between ages 65-90
Who cannot join
- Patient over age 90 and younger the age of 65
- PH level less than 7.3 due to metabolic causes.
- A patient with blood albumin level less than 2.2 g / dl
About this study
This is a single-center, prospective, randomized, comparative, double-blind controlled clinical study intended to establish 1) the optimal method of determining calorie requirements and 2) the optimal amount of protein supply in chronically ventilated patients.
Read the detailed description
The study will be performed in a chronic ventilation department.
Enrolled patients will be randomly allocated to receive calories as dictated by:
The Harriss-Benedict formula (Group 1) or Indirect Calorimetry (Group 2)
After one week of admission to the hospital department and study enrollment we will review the first results of the study.
After seven days of hospitalization and study enrollment patients who have not been weaned from the ventilator, will be divided into three groups.
- Patients in the first group will receive caloric support calculated by the HARRISS BENEDICT equation and protein dose of 1.1 to 1.5 grams per kilogram weight.
- Patients in the second group will receive caloric support as measured by indirect calorimetry and will receive protein at 1.1 grams per kilogram weight.
- Patients in the third group will receive caloric support as measured by indirect calorimetry and will receive protein at a dose of 1.5 grams per kilogram weight.
Outcome of treatment results will be performed after one ,four and eight weeks:
- Length of hospitalization
- Weaning from Mechanical Ventilation
- Development and progression of pressure ulcers
- Infectious diseases incidence
- Amount of insulin needed for glucose control
- Length of mechanical ventilation
- Readmission to Intensive Care Unit
- Mortality rate
- Conditions
- Critically Ill
- Being tested
- Caloric Support (Group 1), Caloric Support (Group 2), Protein dose of 1.1 to 1.5 grams per kilogram weight., Protein at 1.1 grams per kilogram weight., protein at a dose of 1.5 grams per kilogram weight.
- Keywords
- Mechanical Ventilation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric Support (Group 1)Other
Four group 1-dose of caloric support will be calculated by Hariss-Benedict Formula measurement of Resting Energy Expenditure(REE).
Caloric Support (Group 2)Other
For group 2- dose of caloric support will be calculated by Indirect Calorimetric measurement of Resting Energy Expenditure(REE)
Protein dose of 1.1 to 1.5 grams per kilogram weight.Dietary supplement
Patients in the first group(Group 1A) will receive caloric support calculated by the HARRISS BENEDICT equation and protein dose of 1.1 to 1.5 grams per kilogram weight.
Protein at 1.1 grams per kilogram weight.Dietary supplement
Patients in the second group(Group 2A) will receive caloric support as measured by indirect calorimetry and will receive protein at 1.1 grams per kilogram weight.
protein at a dose of 1.5 grams per kilogram weight.Dietary supplement
Patients in the third group (Group 3A) will receive caloric support as measured by indirect calorimetry and will receive protein at a dose of 1.5 grams per kilogram weight.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Patients will be receive caloric support as dictated by Hariss-Benedict Formula (Group 1) Receives: Other: Caloric Support (Group 1) |
| Group 2 | Active comparator | Patients will be receive caloric support as dictated by Indirect Calorimetry (Group 2) Receives: Other: Caloric Support (Group 2) |
| Group 1A | Active comparator | After seven days of hospitalization and study enrollment patients who have not been weaned from ventilator, will be divided into three groups.
Patients in the first(Group 1A)group will receive caloric support calculated by the HARISS BENEDICT equation and protein dose of 1.1 to 1.5 grams per kilogram weight. Receives: Dietary Supplement: Protein dose of 1.1 to 1.5 grams per kilogram weight. |
| Group 2A | Active comparator | After seven days of hospitalization and study enrollment patients who have not been weaned from ventilator, will be divided into three groups.
Patients in the second group(Group 2A) will receive caloric support as measured by indirect calorimetry and will receive protein at 1.1 grams per kilogram weight. Receives: Dietary Supplement: Protein at 1.1 grams per kilogram weight. |
| Group 3A | Active comparator | After seven days of hospitalization and study enrollment patients who have not been weaned from ventilator, will be divided into three groups.
Patients in the third group will receive caloric support as measured by indirect calorimetry and will receive protein at a dose of 1.5 grams per kilogram weight. Receives: Dietary Supplement: protein at a dose of 1.5 grams per kilogram weight. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful weaning from ventilation
Spontaneous breathing
Measured: At one, four and eight weeks
Length of hospital stay
Length of hospitalization, in days
Measured: At 8 weeks
Readmission to Intensive Care Unit
Measured: At four and eight weeks.
Readmission to Intensive Care Unit Mortality
Measured: At eight weeks
Length of mechanical ventilation
Length of mechanical ventilation in days/hours
Measured: At one, four and eight weeks
Secondary outcomes (3)
Infectious diseases incidence
Measured: At one, four and eight weeks
Development and progression of pressure ulcers
Measured: At one, four and eight weeks
Checked daily insulin intake among different groups of patients
Glucose Control
Measured: After one, four and eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012 (estimated)
- Study completionNov 2012 (estimated)
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Beit Rivka Hospital
- Investigators
- Gregory Papirov, MD, Principal investigator, Beit- Rivka Hospital, Petah-Tikva, IsraelPierre Singer, MD, Professor, Study director, ICU, Rabin Medical Center,Petah- Tikva, IsraelLudmila Zaidenberg, MD, Study director, Beit Rivka hospital, Petah- Tikva, IsraelMilana Grinev, RN,Study Coordinator, Study director, ICU, Rabin Medical Center,Petah- Tikva, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142570
- Sponsor's protocol ID
- 5668
- Status last verified
- Jan 2010
- First submitted
- 13 May 2010
- Last updated
- 5 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Enteral Nutrition Enriched in Protein and Based on Indirect Calorimetry Measurement in Chronically Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01142570
- Acronym / sponsor ID
- 5668
- Conditions
- Critically Ill
- Keywords
- Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Beit Rivka Hospital
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 11 Jun 2010 (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.
This is a single-center, prospective, randomized, comparative, double-blind controlled clinical study intended to establish 1) the optimal method of determining calorie requirements and 2) the optimal amount of protein supply in chronically ventilated patients.
Detailed description
The study will be performed in a chronic ventilation department.
Enrolled patients will be randomly allocated to receive calories as dictated by:
The Harriss-Benedict formula (Group 1) or Indirect Calorimetry (Group 2)
After one week of admission to the hospital department and study enrollment we will review the first results of the study.
After seven days of hospitalization and study enrollment patients who have not been weaned from the ventilator, will be divided into three groups.
- Patients in the first group will receive caloric support calculated by the HARRISS BENEDICT equation and protein dose of 1.1 to 1.5 grams per kilogram weight.
- Patients in the second group will receive caloric support as measured by indirect calorimetry and will receive protein at 1.1 grams per kilogram weight.
- Patients in the third group will receive caloric support as measured by indirect calorimetry and will receive protein at a dose of 1.5 grams per kilogram weight.
Outcome of treatment results will be performed after one ,four and eight weeks:
- Length of hospitalization
- Weaning from Mechanical Ventilation
- Development and progression of pressure ulcers
- Infectious diseases incidence
- Amount of insulin needed for glucose control
- Length of mechanical ventilation
- Readmission to Intensive Care Unit
- Mortality rate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Caloric Support (Group 1)Patients will be receive caloric support as dictated by Hariss-Benedict Formula (Group 1) |
| Group 2 | Active comparator | Other: Caloric Support (Group 2)Patients will be receive caloric support as dictated by Indirect Calorimetry (Group 2) |
| Group 1A | Active comparator | Dietary Supplement: Protein dose of 1.1 to 1.5 grams per kilogram weight.After seven days of hospitalization and study enrollment patients who have not been weaned from ventilator, will be divided into three groups. Patients in the first(Group 1A)group will receive caloric support calculated by the HARISS BENEDICT equation and protein dose of 1.1 to 1.5 grams per kilogram weight. |
| Group 2A | Active comparator | Dietary Supplement: Protein at 1.1 grams per kilogram weight.After seven days of hospitalization and study enrollment patients who have not been weaned from ventilator, will be divided into three groups. Patients in the second group(Group 2A) will receive caloric support as measured by indirect calorimetry and will receive protein at 1.1 grams per kilogram weight. |
| Group 3A | Active comparator | Dietary Supplement: protein at a dose of 1.5 grams per kilogram weight.After seven days of hospitalization and study enrollment patients who have not been weaned from ventilator, will be divided into three groups. Patients in the third group will receive caloric support as measured by indirect calorimetry and will receive protein at a dose of 1.5 grams per kilogram weight. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Chronically Mechanical Ventilated Patients (more than 21 days of Mechanical Ventilation) by tracheostomy,
- Between ages 65-90
Key exclusion criteria (3 listed)
- Patient over age 90 and younger the age of 65
- PH level less than 7.3 due to metabolic causes.
- A patient with blood albumin level less than 2.2 g / dl
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 |
|---|---|---|
| Caloric Support (Group 1)Four group 1-dose of caloric support will be calculated by Hariss-Benedict Formula measurement of Resting Energy Expenditure(REE). | Other | Group 1 |
| Caloric Support (Group 2)For group 2- dose of caloric support will be calculated by Indirect Calorimetric measurement of Resting Energy Expenditure(REE) | Other | Group 2 |
| Protein dose of 1.1 to 1.5 grams per kilogram weight.Patients in the first group(Group 1A) will receive caloric support calculated by the HARRISS BENEDICT equation and protein dose of 1.1 to 1.5 grams per kilogram weight. | Dietary supplement | Group 1A |
| Protein at 1.1 grams per kilogram weight.Patients in the second group(Group 2A) will receive caloric support as measured by indirect calorimetry and will receive protein at 1.1 grams per kilogram weight. | Dietary supplement | Group 2A |
| protein at a dose of 1.5 grams per kilogram weight.Patients in the third group (Group 3A) will receive caloric support as measured by indirect calorimetry and will receive protein at a dose of 1.5 grams per kilogram weight. | Dietary supplement | Group 3A |
Primary outcome
Successful weaning from ventilation
Time frame: At one, four and eight weeks
Spontaneous breathing
Length of hospital stay
Time frame: At 8 weeks
Length of hospitalization, in days
Readmission to Intensive Care Unit
Time frame: At four and eight weeks.
Readmission to Intensive Care Unit Mortality
Time frame: At eight weeks
Length of mechanical ventilation
Time frame: At one, four and eight weeks
Length of mechanical ventilation in days/hours
3 secondary outcomes
Infectious diseases incidence
Time frame: At one, four and eight weeks
Development and progression of pressure ulcers
Time frame: At one, four and eight weeks
Checked daily insulin intake among different groups of patients
Time frame: After one, four and eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2010.
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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.
Gregory Papirov, MD principal investigator
Beit- Rivka Hospital, Petah-Tikva, Israel
Pierre Singer, MD, Professor study director
ICU, Rabin Medical Center,Petah- Tikva, Israel
Ludmila Zaidenberg, MD study director
Beit Rivka hospital, Petah- Tikva, Israel
Questions about this trial
What is this clinical trial studying?
A study testing Caloric Support (Group 1), Caloric Support (Group 2) and Protein dose of 1.1 to 1.5 grams per kilogram weight. in people with Critically Ill, run by Rabin Medical Center.
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 2 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: status not confirmed, as of the sponsor's last update on 5 Oct 2010. 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.
Are results available for this study?
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?
Successful weaning from ventilation (time frame: At one, four and eight weeks). The study lists 5 primary outcomes in all. 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 5 Oct 2010.