Critical IllnessPhase 3TOP-UPNCT01206166
Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients (TOP-UP)
A Phase 3 study testing Olimel (5.7%E / N9E) in people with Critical Illness and Acute Respiratory Failure, run by Clinical Evaluation Research Unit at Kingston General Hospital at 12 sites in 4 countries.
Trial summary
The specific aim of the proposed study is to conduct a pilot study involving 160 critically-ill lean and obese patients enrolled at 11 sites in Canada, the United States of America, Belgium and France in order to: Specific Aims Confirm that we can achieve a clinically significant difference in calorie and protein… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Acute Respiratory Failure
- What is being tested?
- Olimel (5.7%E / N9E)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Jun 2011to Jul 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 adult patient (≥ 18 years) admitted to ICU
- Has acute respiratory failure (ARF) i.e. expected to remain mechanically ventilated for more than 48 hours
- Expected ICU dependency of 5 or more days
- On or expected to initiate enteral nutrition within 7 days of ICU admission
- BMI <25 or ≥ 35 based on pre-ICU actual or estimated dry weight
Who cannot join
- >72 hours from admission to ICU to time of consent
- Not expected to survive an additional 48 hrs from screening evaluation
- A lack of commitment to full aggressive care (anticipated withholding or withdrawing treatments in the first week but isolated DNR acceptable)
- Patients already receiving PN at screening
- Absence of All gastrointestinal risk factors, defined as:
- High Apache II Score (>20)
Show all 22Show fewer
- On more than 1 vasopressor or increasing doses or vasopressors
- Receiving continuous infusion of narcotics
- High nasogastric/orogastric output (>500 mL over 24 hours)
- Recent surgery involving esophagus, stomach, or small bowel OR peritoneal contamination with bowel contents
- Pancreatitis
- Multiple gastrointestinal investigations
- Recent history of diarrhea/C. Difficile
- Surgical patients with future surgeries planned
- Ruptured or dissected abdominal aortic aneurysm
- Patients admitted with diabetic ketoacidosis or non-ketotic hyperosmolar coma
- Pregnant or lactating patients
- Patients with clinical fulminant hepatic failure
- Patients with Cirrhosis Child's Class C Liver Disease (except those on a transplant list or transplantable)
- Dedicated port of central line not available
- Known allergy to study nutrients (soy, eggs or olive products)
- Enrolment in another industry sponsored ICU intervention study
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
United States7 sites
University of Colorado DHSC
Boulder, Colorado, 80045
Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, 44195
The Ohio State Univsersity Medical Center
Columbus, Ohio, 43221
University of Texas Health Science Center
Houston, Texas, 77030
Oregon Health & Science University
Portland, Oregon, 97239-3098
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110-1093
Mercy Hospital St. Louis
St Louis, Missouri, 63141
Canada3 sites
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
University of Alberta
Edmonton, Alberta, T5H 3V9
Grey Nuns Hospital
Edmonton, Alberta, T6L 5X8
About this study
Official title: A Randomized Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients: The TOP UP Trial (Pilot)
The specific aim of the proposed study is to conduct a pilot study involving 160 critically-ill lean and obese patients enrolled at 11 sites in Canada, the United States of America, Belgium and France in order to:
Specific Aims
Read more
- Confirm that we can achieve a clinically significant difference in calorie and protein intake between the two intervention groups.
- Estimate recruitment rate i.e. number of eligible and enrolled patients per month per site.
- Evaluate the safety, tolerance, and logistics around providing supplemental PN in the study population in the context of a multicenter trial, e.g.
- To ensure adequate glycemic control in both groups.
- To ensure that the other metabolic consequences of the feeding strategies are minimized.
- To establish adequate compliance with study protocols and completion of case report forms
A secondary aim of this pilot study will be:
- To explore the effect of differential effects of calorie and protein delivery on muscle and mass function.
Read the detailed description
Background
Critically ill patients are often hypermetabolic and can rapidly become nutritionally compromised. Malnutrition is prevalent in these patients and has been associated with increased morbidity and mortality. Standard nutrition therapy, i.e. provision of calories, protein and other nutrients consists primarily of enteral nutrition (via a feeding tube into the gastrointestinal tract), parenteral nutrition (via an intravenous tube into the blood), or occasionally a combination of both.
However, the provision of nutrition is sub-optimal and the majority of critically-ill patients do not meet nutritional requirements. Recent studies report that average energy intakes of critically ill patients are only 49% to 70% of calculated requirements. Despite repeated, sustained efforts over the past few years, the investigators have not significantly improved the amount of calories delivered via the enteral route. This leads us to conclude that if the investigators are to be successful at increasing the provision of calories and protein to patients at-risk, the investigators will have to supplement the calories via the parenteral route.
Critically ill patients that are at extremes of weight are at a higher nutritional risk and have higher mortality rates. A recent International multicenter observational study of 2772 ICU patients from 165 ICUs showed a significant inverse linear relationship between the odds of mortality and total daily calories received. Increased amounts of calories was most important for the BMI < 20 group followed by the BMI 20 -< 25 group and BMI > 35 group with no benefit of increased calorie intake for patients in the BMI 25 -< 35 group. Feeding an additional 1000 kcals almost halved the odds of 60-day mortality in patients with a BMI < 25 or > 35. Similar results were observed for feeding an additional 30 grams of protein per day.
Thus, a prospective randomized trial is warranted to confirm our hypothesis that in patients with a BMI of < 25 and those with a BMI > 35 increasing the provision of more energy and protein can impact clinical outcomes. The results of this study will serve to answer some fundamental questions with regards to impact of amount of energy and protein delivered to nutritional at-risk ICU patients and will inform current practice.
Study Intervention:
Patients will be randomized to one of 2 interventions: enteral nutrition alone or enteral nutrition plus parenteral nutrition (supplemental PN group).
- Conditions
- Critical Illness, Acute Respiratory Failure
- Being tested
- Olimel (5.7%E / N9E)
- Keywords
- Randomized trial, Parental nutrition, Enteral nutrition, Intensive care unit, BMI < 25 or ≥ 35
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olimel (5.7%E / N9E)Drug
Also called Olimel
OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
| Study group | Role | What they receive |
|---|---|---|
| Enteral Nutrition + Parenteral Nutrition | Experimental | Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Receives: Drug: Olimel (5.7%E / N9E) |
| Enteral Nutrition Only | No intervention | Enteral nutrition only - no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calorie & Protein Intake 7 Days Post Randomization
Amount of calories \& protein received as a percentage of prescribed.
Measured: 7 days post randomization
Calorie & Protein Intake in First 27 Days
Amount of calories \& protein received as a percentage of prescribed.
Measured: first 27 days
Secondary outcomes (28)
6 Month Mortality
Kaplan-Meier estimate.
Measured: 6 months
ICU Mortality
Measured: 6 months
Hospital Mortality
Measured: 6 months
Duration of ICU Stay
Measured: 6 months
Duration of Hospital Stay
Measured: 6 months
Duration of Mechanical Ventilation
Measured: 6 months
Development of ICU-acquired Infections
Measured: ICU discharge
SF36-Physical Functioning Domain
The SF-36 physical function domain ranges from 0-100. Higher scores indicate better outcome.
Measured: 3 months
SF-36 Physical Functioning Domain
The SF-36 physical function domain ranges from 0-100. Higher scores indicate better outcome.
Measured: 6 months
Functional Status at Hospital Discharge
Measured: hospital discharge
SF36 Role Physical Domain
The SF-36 role physical function domain ranges from 0-100. Higher scores indicate better outcome.
Measured: 3 months
SF36 Pain Index Domain
The SF-36 pain index domain ranges from 0-100. Higher scores indicate better outcome.
Measured: 3 months
SF36 General Health Perceptions Domain
The SF-36 general health perceptions domain ranges from 0-100. Higher scores indicate better outcome.
Measured: 3 months
SF36 Vitality Domain
The SF-36 vitality domain ranges from 0-100. Higher scores indicate better outcome.
Measured: 3 months
SF36 Social Functioning Domain
The SF-36 social functioning domain ranges from 0-100. Higher scores indicate better outcome.
Measured: 3 months
SF36 Role-emotional Domain
The SF-36 role-emotion domain ranges from 0-100. Higher scores indicate better outcome.
Measured: 3 months
SF36 Mental Health Index Domain
The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.
Measured: 3 months
SF36 Standardized Physical Component Scale
The SF36 Standardized Physical Component Scale has been scaled to have a mean of zero and standard deviation of 10 in a general US population. Higher scores indicate better HRQoL.
Measured: 3 months
SF36 Standardized Mental Component Scale
The SF36 Standardized Mental Component Scale has been scaled to have a mean of zero and standard deviation of 10 in a general US population. Higher scores indicate better HRQoL.
Measured: 3 months
SF-36 Role-physical Domain
The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.
Measured: 6 months
SF-36 Pain Index Domain
The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.
Measured: 6 months
SF-36 General Health Perceptions Domain
The SF-36 general health perceptions domain ranges from 0-100. Higher scores indicate better outcome.
Measured: 6 months
SF-36 Vitality Domain
The SF-36 vitality domain ranges from 0-100. Higher scores indicate better outcome.
Measured: 6 months
SF-36 Social Functioning Domain
The SF-36 social functioning domain ranges from 0-100. Higher scores indicate better outcome.
Measured: 6 months
SF-36 Role-emotional Domain
The SF-36 role-emotional domain ranges from 0-100. Higher scores indicate better outcome.
Measured: 6 months
SF-36 Mental Health Index Domain
The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.
Measured: 6 months
SF-36 Standardized Physical Component Scale
The SF36 Standardized Physical Component Scale has been scaled to have a mean of zero and standard deviation of 10 in a general US population. Higher scores indicate better HRQoL.
Measured: 6 months
SF-36 Standardized Mental Component Scale
The SF36 Standardized mental Component Scale has been scaled to have a mean of zero and standard deviation of 10 in a general US population. Higher scores indicate better HRQoL.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2010 (estimated)
- Study startJun 2011
- Primary completionMar 2015
- Study completionJul 2015
Why it stopped: Low enrollment rates.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Evaluation Research Unit at Kingston General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
- Investigators
- Daren K. Heyland, MD, Study chair, Clinical Evaluation Research Unit, Kingston General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206166
- Sponsor's protocol ID
- TOP-UP
- Acronym
- TOP-UP
- Status last verified
- Feb 2021
- First submitted
- 14 Sep 2010
- Last updated
- 16 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Alberda C, Gramlich L, Jones N, Jeejeebhoy K, Day AG, Dhaliwal R, Heyland DK. The relationship between nutritional intake and clinical outcomes in critically ill patients: results of an international multicenter observational study. Intensive Care Med. 2009 Oct;35(10):1728-37. doi: 10.1007/s00134-009-1567-4. Epub 2009 Jul 2.
PubMed 19572118Villet S, Chiolero RL, Bollmann MD, Revelly JP, Cayeux R N MC, Delarue J, Berger MM. Negative impact of hypocaloric feeding and energy balance on clinical outcome in ICU patients. Clin Nutr. 2005 Aug;24(4):502-9. doi: 10.1016/j.clnu.2005.03.006.
PubMed 15899538Krishnan JA, Parce PB, Martinez A, Diette GB, Brower RG. Caloric intake in medical ICU patients: consistency of care with guidelines and relationship to clinical outcomes. Chest. 2003 Jul;124(1):297-305. doi: 10.1378/chest.124.1.297.
PubMed 12853537Hise ME, Halterman K, Gajewski BJ, Parkhurst M, Moncure M, Brown JC. Feeding practices of severely ill intensive care unit patients: an evaluation of energy sources and clinical outcomes. J Am Diet Assoc. 2007 Mar;107(3):458-65. doi: 10.1016/j.jada.2006.12.012.
PubMed 17324665Dhaliwal R, Jurewitsch B, Harrietha D, Heyland DK. Combination enteral and parenteral nutrition in critically ill patients: harmful or beneficial? A systematic review of the evidence. Intensive Care Med. 2004 Aug;30(8):1666-71. doi: 10.1007/s00134-004-2345-y. Epub 2004 Jun 8.
PubMed 15185069Wischmeyer PE, Hasselmann M, Kummerlen C, Kozar R, Kutsogiannis DJ, Karvellas CJ, Besecker B, Evans DK, Preiser JC, Gramlich L, Jeejeebhoy K, Dhaliwal R, Jiang X, Day AG, Heyland DK. A randomized trial of supplemental parenteral nutrition in underweight and overweight critically ill patients: the TOP-UP pilot trial. Crit Care. 2017 Jun 9;21(1):142. doi: 10.1186/s13054-017-1736-8.
PubMed 28599676
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients: The TOP UP Trial (Pilot)
- ClinicalTrials.gov ID
- NCT01206166
- Acronym / sponsor ID
- TOP-UP / TOP-UP
- Conditions
- Critical Illness, Acute Respiratory Failure
- Keywords
- Randomized trial, Parental nutrition, Enteral nutrition, Intensive care unit, BMI < 25 or ≥ 35
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment rates.
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Clinical Evaluation Research Unit at Kingston General HospitalUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Jun 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 21 Sep 2010 (estimated)
- Results
- Posted 16 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aim of the proposed study is to conduct a pilot study involving 160 critically-ill lean and obese patients enrolled at 11 sites in Canada, the United States of America, Belgium and France in order to:
Specific Aims
- Confirm that we can achieve a clinically significant difference in calorie and protein intake between the two intervention groups.
- Estimate recruitment rate i.e. number of eligible and enrolled patients per month per site.
- Evaluate the safety, tolerance, and logistics around providing supplemental PN in the study population in the context of a multicenter trial, e.g.
- To ensure adequate glycemic control in both groups.
- To ensure that the other metabolic consequences of the feeding strategies are minimized.
- To establish adequate compliance with study protocols and completion of case report forms
A secondary aim of this pilot study will be:
- To explore the effect of differential effects of calorie and protein delivery on muscle and mass function.
Detailed description
Background
Critically ill patients are often hypermetabolic and can rapidly become nutritionally compromised. Malnutrition is prevalent in these patients and has been associated with increased morbidity and mortality. Standard nutrition therapy, i.e. provision of calories, protein and other nutrients consists primarily of enteral nutrition (via a feeding tube into the gastrointestinal tract), parenteral nutrition (via an intravenous tube into the blood), or occasionally a combination of both.
However, the provision of nutrition is sub-optimal and the majority of critically-ill patients do not meet nutritional requirements. Recent studies report that average energy intakes of critically ill patients are only 49% to 70% of calculated requirements. Despite repeated, sustained efforts over the past few years, the investigators have not significantly improved the amount of calories delivered via the enteral route. This leads us to conclude that if the investigators are to be successful at increasing the provision of calories and protein to patients at-risk, the investigators will have to supplement the calories via the parenteral route.
Critically ill patients that are at extremes of weight are at a higher nutritional risk and have higher mortality rates. A recent International multicenter observational study of 2772 ICU patients from 165 ICUs showed a significant inverse linear relationship between the odds of mortality and total daily calories received. Increased amounts of calories was most important for the BMI < 20 group followed by the BMI 20 -< 25 group and BMI > 35 group with no benefit of increased calorie intake for patients in the BMI 25 -< 35 group. Feeding an additional 1000 kcals almost halved the odds of 60-day mortality in patients with a BMI < 25 or > 35. Similar results were observed for feeding an additional 30 grams of protein per day.
Thus, a prospective randomized trial is warranted to confirm our hypothesis that in patients with a BMI of < 25 and those with a BMI > 35 increasing the provision of more energy and protein can impact clinical outcomes. The results of this study will serve to answer some fundamental questions with regards to impact of amount of energy and protein delivered to nutritional at-risk ICU patients and will inform current practice.
Study Intervention:
Patients will be randomized to one of 2 interventions: enteral nutrition alone or enteral nutrition plus parenteral nutrition (supplemental PN group).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteral Nutrition + Parenteral Nutrition | Experimental | Drug: Olimel (5.7%E / N9E)Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). |
| Enteral Nutrition Only | No intervention | –Enteral nutrition only - no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Critically ill adult patient (≥ 18 years) admitted to ICU
- Has acute respiratory failure (ARF) i.e. expected to remain mechanically ventilated for more than 48 hours
- Expected ICU dependency of 5 or more days
- On or expected to initiate enteral nutrition within 7 days of ICU admission
- BMI <25 or ≥ 35 based on pre-ICU actual or estimated dry weight
Key exclusion criteria (22 listed)
- >72 hours from admission to ICU to time of consent
- Not expected to survive an additional 48 hrs from screening evaluation
- A lack of commitment to full aggressive care (anticipated withholding or withdrawing treatments in the first week but isolated DNR acceptable)
- Patients already receiving PN at screening
- Absence of All gastrointestinal risk factors, defined as:
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 |
|---|---|---|
| Olimel (5.7%E / N9E)Also: OlimelOLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated. | Drug | Enteral Nutrition + Parenteral Nutrition |
Primary outcome
Calorie & Protein Intake 7 Days Post Randomization
Time frame: 7 days post randomization
Amount of calories \& protein received as a percentage of prescribed.
Calorie & Protein Intake in First 27 Days
Time frame: first 27 days
Amount of calories \& protein received as a percentage of prescribed.
28 secondary outcomes
6 Month Mortality
Time frame: 6 months
ICU Mortality
Time frame: 6 months
Hospital Mortality
Time frame: 6 months
Duration of ICU Stay
Time frame: 6 months
Duration of Hospital Stay
Time frame: 6 months
Duration of Mechanical Ventilation
Time frame: 6 months
Development of ICU-acquired Infections
Time frame: ICU discharge
SF36-Physical Functioning Domain
Time frame: 3 months
SF-36 Physical Functioning Domain
Time frame: 6 months
Functional Status at Hospital Discharge
Time frame: hospital discharge
SF36 Role Physical Domain
Time frame: 3 months
SF36 Pain Index Domain
Time frame: 3 months
SF36 General Health Perceptions Domain
Time frame: 3 months
SF36 Vitality Domain
Time frame: 3 months
SF36 Social Functioning Domain
Time frame: 3 months
SF36 Role-emotional Domain
Time frame: 3 months
SF36 Mental Health Index Domain
Time frame: 3 months
SF36 Standardized Physical Component Scale
Time frame: 3 months
SF36 Standardized Mental Component Scale
Time frame: 3 months
SF-36 Role-physical Domain
Time frame: 6 months
SF-36 Pain Index Domain
Time frame: 6 months
SF-36 General Health Perceptions Domain
Time frame: 6 months
SF-36 Vitality Domain
Time frame: 6 months
SF-36 Social Functioning Domain
Time frame: 6 months
SF-36 Role-emotional Domain
Time frame: 6 months
SF-36 Mental Health Index Domain
Time frame: 6 months
SF-36 Standardized Physical Component Scale
Time frame: 6 months
SF-36 Standardized Mental Component Scale
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19572118Alberda C, Gramlich L, Jones N, Jeejeebhoy K, Day AG, Dhaliwal R, Heyland DK. The relationship between nutritional intake and clinical outcomes in critically ill patients: results of an international multicenter observational study. Intensive Care Med. 2009 Oct;35(10):1728-37. doi: 10.1007/s00134-009-1567-4. Epub 2009 Jul 2.
- Background: PubMed 15899538Villet S, Chiolero RL, Bollmann MD, Revelly JP, Cayeux R N MC, Delarue J, Berger MM. Negative impact of hypocaloric feeding and energy balance on clinical outcome in ICU patients. Clin Nutr. 2005 Aug;24(4):502-9. doi: 10.1016/j.clnu.2005.03.006.
- Background: PubMed 12853537Krishnan JA, Parce PB, Martinez A, Diette GB, Brower RG. Caloric intake in medical ICU patients: consistency of care with guidelines and relationship to clinical outcomes. Chest. 2003 Jul;124(1):297-305. doi: 10.1378/chest.124.1.297.
- Background: PubMed 17324665Hise ME, Halterman K, Gajewski BJ, Parkhurst M, Moncure M, Brown JC. Feeding practices of severely ill intensive care unit patients: an evaluation of energy sources and clinical outcomes. J Am Diet Assoc. 2007 Mar;107(3):458-65. doi: 10.1016/j.jada.2006.12.012.
- Background: PubMed 15185069Dhaliwal R, Jurewitsch B, Harrietha D, Heyland DK. Combination enteral and parenteral nutrition in critically ill patients: harmful or beneficial? A systematic review of the evidence. Intensive Care Med. 2004 Aug;30(8):1666-71. doi: 10.1007/s00134-004-2345-y. Epub 2004 Jun 8.
- Derived from this study: PubMed 28599676Wischmeyer PE, Hasselmann M, Kummerlen C, Kozar R, Kutsogiannis DJ, Karvellas CJ, Besecker B, Evans DK, Preiser JC, Gramlich L, Jeejeebhoy K, Dhaliwal R, Jiang X, Day AG, Heyland DK. A randomized trial of supplemental parenteral nutrition in underweight and overweight critically ill patients: the TOP-UP pilot trial. Crit Care. 2017 Jun 9;21(1):142. doi: 10.1186/s13054-017-1736-8.
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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.
Daren K. Heyland, MD study chair
Clinical Evaluation Research Unit, Kingston General Hospital
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olimel (5.7%E / N9E) in people with Critical Illness and Acute Respiratory Failure, run by Clinical Evaluation Research Unit at Kingston General Hospital at 12 sites in 4 countries.
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 5 inclusion and 22 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 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada, Belgium, France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Calorie & Protein Intake 7 Days Post Randomization (time frame: 7 days post randomization). The study lists 2 primary outcomes in all. 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 NCT01206166, which also lists 6 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 16 Mar 2021.