Mechanical Ventilation ComplicationP2 -RMCSNCT01479673
TICACOS International
A study testing Indirect Calorimetry measurement of Resting Energy Expenditure . in people with Mechanical Ventilation Complication, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to perform a prospective, randomized, controlled blinded study in critically patients to assess the necessity for measuring daily resting energy expenditure as a guide for nutritional support. Our hypothesis is that tight caloric control will reduce the rate of new infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- Indirect Calorimetry measurement of Resting Energy Expenditure .
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2011to Dec 2014
- 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
- Mechanically-ventilated adults(Male or Female)admitted to general ICU within the first 48 hours of ICU admission.
- Age ≥ 18 years;no upper age limit.
- Expected stay in ICU> 3 days: [SAPS II (18) > ICU median or high-level of nursing care implemented or per clinical impression of attending physician]
- Medical and abdomino/thoracic surgery patients, as well as multiple trauma patients with Glasgow Coma Score ≥ 10.
Who cannot join
- Pregnancy.
- DNR order.
- Readmission in the ICU during the same hospitalization/transfer from other ICU.
- Admission for postoperative monitoring.
- Respiratory instability: SpO2 <90% or need for ventilator adjustments during the preceding hour or hyperventilation (Respiratory rate > 35/min)
- Bicarbonate infusion, loss of bicarbonate (diarrhea, ureterosogmoidostomy or use of acetazoloamide, ultrafiltration).
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- Aerosolization with nitric oxide or heliox, tracheal insufflations or visible leaks in chest drainage system.
- FiO2 80% or patients requiring prone position
- Chronic/acute liver failure:Child-Pugh class C
- Brain injury for various reasons with Glasgow Coma Scale below 10.
- Cardiac surgery patients.
- Patients in the hospital for more than 7 days.
- Contra indication to use enteral nutrition.
- Participation in a clinical study with an investigational drug within one month prior to the start of this clinical trial.
- Ethical issues that will influence subject eligibility.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center, Campus Beilinson
Petah Tikva, Petach Tikva, 49100
Pierre Singer, Professor,MD, 972-39376521, psinger@clalit.org.il
Milana Grinev, Study Coordinator, 972-39376590, milang@clalit.org.il
About this study
Official title: Tight Caloric Balance in ICU Patients: a Multicenter, Prospective, Randomized, Controlled Study.
The aim of this study is to perform a prospective, randomized, controlled blinded study in critically patients to assess the necessity for measuring daily resting energy expenditure as a guide for nutritional support. Our hypothesis is that tight caloric control will reduce the rate of new infections.
Study Design :Multi-center, randomized, single blinded, controlled study. Study Population: newly-admitted, adult mechanically ventilated ICU patients.
Read the detailed description
Study objectives
To evaluate the effect of tight caloric control in critical patients on:
- The rate of acquired nosocomial infections (Ventilated associated pneumonia, Catheter related infections, Urinary tract infections)
- Mortality rates, length of stay in the ICU and in hospital, length of ventilation and incidence of non-infectious complications.
Primary endpoint:
Rate of nosocomial infections (for definitions see appendage 1) acquired after 48 to 72 hours following admission.
Secondary endpoints
- Metabolic control: glucose concentration, insulin administration, rate of hypoglycemic events.
- Success of tight caloric control: accumulative and maximum negative energy balance.
- Organ function: SOFA score.
- Rate of non-infectious complications: requirement for surgery or occurrence of pressure sores.
- Length of ICU stay and of assisted ventilation (LOS and LOV)
- ICU survival rate.
- Patient status and disposition on day 28 or at hospital discharge.
- 3 \& 6 months survival.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- Indirect Calorimetry measurement of Resting Energy Expenditure .
- Keywords
- Enteral Nutrition, Parenteral Nutrition, Indirect Calorimetry, Intravenous Feeding
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect Calorimetry measurement of Resting Energy Expenditure .Dietary supplement
Patients in this group will receive enteral nutrition/parenteral nutrition or combination of enteral and parenteral nutrition according to the individual energy requirements calculated by Indirect Calorimetry.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients in this group will receive enteral nutrition/parenteral nutrition or combination of enteral and parenteral nutrition according to the "liberal " regimen, i.e. according to local practice. |
| Indirect Calorimetry | Experimental | Study group: Indirect Calorimetry (IC) Patients in this group will receive enteral nutrition/parenteral nutrition or combination of enteral and parenteral nutrition according to the individual energy requirements calculated by Indirect Calorimetry measurement of Resting Energy Expenditure (REE). Receives: Dietary Supplement: Indirect Calorimetry measurement of Resting Energy Expenditure . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of nosocomial infections
Rate of nosocomial infections acquired after 48 to 72 hours following admission up to day 28/or discharge will be evaluated
Measured: After 48 to 72 hours /daily assessment: within 28 day
Secondary outcomes (2)
Metabolic control
Glucose concentration, insulin administration, rate of hypoglycemic events will be daily assessed
Measured: Day 1 up to day 28/or discharge
Caloric control
Success of tight caloric control:accumulative and maximum negative energy balance
Measured: Day 1 up to day 28/or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Pierre singer, Rabin Medical Center
- Investigators
- Pierre Singer, MD, Professor, Principal investigator, RabinMC,Beilinson HospitalMilana Grinev, RN,Study Coordinator, Study director, RabinMC, Beilinson Hospital ,Petah- Tikva, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479673
- Sponsor's protocol ID
- 4329
- Acronym
- P2 -RMCS
- Status last verified
- Nov 2013
- First submitted
- 22 Nov 2011
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tight Caloric Balance in ICU Patients: a Multicenter, Prospective, Randomized, Controlled Study.
- ClinicalTrials.gov ID
- NCT01479673
- Acronym / sponsor ID
- P2 -RMCS / 4329
- Conditions
- Mechanical Ventilation Complication
- Keywords
- Enteral Nutrition, Parenteral Nutrition, Indirect Calorimetry, Intravenous Feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Nov 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 24 Nov 2011 (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.
The aim of this study is to perform a prospective, randomized, controlled blinded study in critically patients to assess the necessity for measuring daily resting energy expenditure as a guide for nutritional support. Our hypothesis is that tight caloric control will reduce the rate of new infections.
Study Design :Multi-center, randomized, single blinded, controlled study. Study Population: newly-admitted, adult mechanically ventilated ICU patients.
Detailed description
Study objectives
To evaluate the effect of tight caloric control in critical patients on:
- The rate of acquired nosocomial infections (Ventilated associated pneumonia, Catheter related infections, Urinary tract infections)
- Mortality rates, length of stay in the ICU and in hospital, length of ventilation and incidence of non-infectious complications.
Primary endpoint:
Rate of nosocomial infections (for definitions see appendage 1) acquired after 48 to 72 hours following admission.
Secondary endpoints
- Metabolic control: glucose concentration, insulin administration, rate of hypoglycemic events.
- Success of tight caloric control: accumulative and maximum negative energy balance.
- Organ function: SOFA score.
- Rate of non-infectious complications: requirement for surgery or occurrence of pressure sores.
- Length of ICU stay and of assisted ventilation (LOS and LOV)
- ICU survival rate.
- Patient status and disposition on day 28 or at hospital discharge.
- 3 \& 6 months survival.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients in this group will receive enteral nutrition/parenteral nutrition or combination of enteral and parenteral nutrition according to the "liberal " regimen, i.e. according to local practice. |
| Indirect Calorimetry | Experimental | Dietary Supplement: Indirect Calorimetry measurement of Resting Energy Expenditure .Study group: Indirect Calorimetry (IC) Patients in this group will receive enteral nutrition/parenteral nutrition or combination of enteral and parenteral nutrition according to the individual energy requirements calculated by Indirect Calorimetry measurement of Resting Energy Expenditure (REE). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mechanically-ventilated adults(Male or Female)admitted to general ICU within the first 48 hours of ICU admission.
- Age ≥ 18 years;no upper age limit.
- Expected stay in ICU> 3 days: [SAPS II (18) > ICU median or high-level of nursing care implemented or per clinical impression of attending physician]
- Medical and abdomino/thoracic surgery patients, as well as multiple trauma patients with Glasgow Coma Score ≥ 10.
Key exclusion criteria (15 listed)
- Pregnancy.
- DNR order.
- Readmission in the ICU during the same hospitalization/transfer from other ICU.
- Admission for postoperative monitoring.
- Respiratory instability: SpO2 <90% or need for ventilator adjustments during the preceding hour or hyperventilation (Respiratory rate > 35/min)
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 |
|---|---|---|
| Indirect Calorimetry measurement of Resting Energy Expenditure .Patients in this group will receive enteral nutrition/parenteral nutrition or combination of enteral and parenteral nutrition according to the individual energy requirements calculated by Indirect Calorimetry. | Dietary supplement | Indirect Calorimetry |
Primary outcome
Rate of nosocomial infections
Time frame: After 48 to 72 hours /daily assessment: within 28 day
Rate of nosocomial infections acquired after 48 to 72 hours following admission up to day 28/or discharge will be evaluated
2 secondary outcomes
Metabolic control
Time frame: Day 1 up to day 28/or discharge
Caloric control
Time frame: Day 1 up to day 28/or discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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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.
Pierre Singer, MD, Professor principal investigator
RabinMC,Beilinson Hospital
Milana Grinev, RN,Study Coordinator study director
RabinMC, Beilinson Hospital ,Petah- Tikva, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirect Calorimetry measurement of Resting Energy Expenditure . in people with Mechanical Ventilation Complication, run by Rabin Medical Center at 1 site in Israel.
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 15 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 25 Nov 2013. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Singer, MD,Professor (972-3-9376521, psinger@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of nosocomial infections (time frame: After 48 to 72 hours /daily assessment: within 28 day). 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 25 Nov 2013.