MalnutritionPhase 2NutriSuPNCT02632630
Nutrition Supplementation in Hospitalized Patients
A Phase 2 study testing Amino Acids w/Electrolytes in Dextrose, Ensure product and Crystalloid solutions in people with Malnutrition, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Patients with severe malnutrition risk are 7.4 times more likely to die in hospital than well-nourished patients, and carry a 30-day readmission rate of >46%. Although malnutrition is common and is associated with extremely poor outcomes, it is neglected and undertreated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malnutrition
- What is being tested?
- Amino Acids w/Electrolytes in Dextrose, Ensure product and Crystalloid solutions
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to Feb 2018
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjective Global Assessment (SGA) category B or C.
- Have been hospitalized for less than 48 hours.
Who cannot join
- Have an allergy or intolerance to any component of the oral supplement or parenteral nutrition.
- Have a contraindication to administration of IV fluid (i.e. are in volume overloaded state, are being given IV furosemide).
- Are currently suffering from refeeding syndrome.
- Have a pre-existing medical condition that prevents oral intake of full fluids.
- Have a diagnosis or suspicion of septic shock.
- Have an expected length of stay of less than 48 hours from the time of assessment.
- Have a current diagnosis of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutrition Supplementation in Hospitalized Patients: A Randomized Controlled Trial
Patients with severe malnutrition risk are 7.4 times more likely to die in hospital than well-nourished patients, and carry a 30-day readmission rate of >46%. Although malnutrition is common and is associated with extremely poor outcomes, it is neglected and undertreated. This is a randomized controlled pilot trial to rapidly identify at-risk hospitalized medical patients, and then provide nutritional supplementation in hospital and after discharge for 28 days. In select at-risk patients, 5 days of nutrition delivered through a peripheral vein will be used in addition to oral nutritional supplementation.
Read the detailed description
In this pilot trial, the feasibility of the trial protocol will be established in two centres in Canada. Patients at high risk of malnutrition will be identified within 48 hours of hospital admission using Subjective Global Assessment criteria. Patients will be randomized in a factorial design fashion via a centralized, internet-based randomization protocol to one of the following arms:
- Peripheral parenteral nutrition and enhanced oral supplementation;
- Peripheral parenteral nutrition and standard care for oral supplementation;
- Standard care for parenteral fluid administration and enhanced oral supplementation;
- Standard care for parenteral fluid administration and standard of care for oral supplementation.
Peripheral parenteral nutrition (PPN) is intravenous nutrition consisting of dextrose, amino acids, fat, and electrolytes through a peripheral vein. Peri-OLIMEL 2.5% E, parenteral solution (Baxter) will be administered in this study. Patients will be randomized to PPN vs. standard care intravenous maintenance fluid administration for up to 5 days of hospitalization or until discharge, whichever is sooner. The PPN will be administered in place of their maintenance crystalloid solution, and will be adjusted or stopped as clinically indicated by the attending medical team.
If there is no maintenance crystalloid fluid administration, the parenteral nutrition solution will be administered at a rate of 0.85mL/kg/hour.
The minimum infusion rate will be 45 mL per hour (for participants who weigh 53 kg or less). The minimum infusion rate would provide a supplementation of 1,080 kcal/day.
The maximum infusion rate will be 85 mL/hour (for participants who weigh 100 kg or more). The maximum infusion rate would provide a supplementation of 2,040 kcal/day.
The PPN solution has a low osmolarity (< 900 mOsm) to reduce risk of phlebitis (Peri-OLIMEL 2.5% E is760mOsm). The use of PPN, compared to total parenteral nutrition (TPN) offers safety advantages. PPN avoids cost and complication of central line placement, avoids line sepsis and reduces the likelihood re-feeding syndrome [30-32]. Peri-OLIMEL 2.5% E contains lipids and electrolytes further reducing the likelihood of vein irritation and refeeding syndrome. All patients will be monitored closely and patients with uncontrolled blood sugars will be excluded.
Patients randomized to Oral Nutritional Supplementation (ONS) will receive standard menu or standard menu plus oral nutritional supplements. The investigators will provide patients with one package of ONS (Resource 2.0 - 237 mL, 474 calories; or similar product) two times daily in hospital. Although the patient will be encouraged, they will not be required to consume all of the oral supplementation product. Upon discharge, patients will be provided with ONS product to take home.
All participants will be monitored daily in hospital. After discharge, the investigators will follow up with the participant at a 30-day follow-up clinic visit, to collect data regarding clinical outcomes, quality of life, physical function, and nutrition-related variables.
This pilot study will establish the feasibility of a paradigm-changing protocol that will rapidly identify and aggressively treat malnutrition in hospitalized patients, with the goal of improving function, quality of life, healthcare utilization, and reducing the risk of adverse clinical events.
- Conditions
- Malnutrition
- Being tested
- Amino Acids w/Electrolytes in Dextrose, Ensure product, Crystalloid solutions, Oral nutritional supplementation
- Keywords
- Peripheral Parenteral Nutrition, Oral nutritional supplementation, Acute Care hospitals
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino Acids w/Electrolytes in DextroseDrug
Also called Peri-OLIMEL 2.5% E (Baxter)
Patients will receive peripheral parenteral nutrition to a maximum of 2L/day (with a minimum rate of 45mL/hour and a maximum rate of 85mL/hour) of pre-packaged Peri-OLIMEL 2.5% E. The PPN will be administered in place of their maintenance crystalloid solution, and will be adjusted or stopped as clinically indicated by the attending medical team., for up to 5 days of hospitalization or until discharge, whichever is sooner.
Ensure productDietary supplement
Patients will receive one package of Ensure two times daily in hospital. At discharge, patients randomized to receive Ensure will be provided with 28 packages of Ensure with instructions to attempt to consume 1 package per day.
Crystalloid solutionsDrug
Also called normal saline, dextrose, lactated Ringer's
Standard care intravenous maintenance fluid administration for up to 5 days of hospitalization or until discharge, whichever is sooner.
Oral nutritional supplementationDietary supplement
Standard of care oral nutritional supplementation is determined by the clinician. A dietitian may also be involved.
| Study group | Role | What they receive |
|---|---|---|
| Amino Acids w/Electrolytes in Dextrose | Active comparator | Peripheral parenteral nutrition (PPN) Receives: Drug: Amino Acids w/Electrolytes in Dextrose |
| Ensure product | Active comparator | Calorie and protein dense oral nutritional supplement for patients with elevated nutritional needs. Receives: Dietary Supplement: Ensure product |
| Crystalloid solutions | Active comparator | Standard care intravenous maintenance fluids. Receives: Drug: Crystalloid solutions |
| Oral nutritional supplementation | Active comparator | Nutrient-enhanced drink products that provide macronutrients and micronutrients with the aim of increasing oral nutritional intake. Receives: Dietary Supplement: Oral nutritional supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful participant recruitment
This pilot study will demonstrate feasibility of recruitment if investigators are able to recruit 100 participants over 12 months. A total recruitment of 15 patients/month is considered as reasonable given the high numbers of competing studies, missed patients, and consent failure rates.
Measured: 12 months
Secondary outcomes (2)
Adherence to treatment
Adherence to the study treatments will be defined as ≥90% of prescribed intervention being administered across all patients. Preliminary estimates of non-administration of the trial intervention are needed, along with strategies that maximize exposure to the intervention.
Measured: 30 days
Number of participants to experience clinical re-feeding syndrome.
It is expected that some participants will experience metabolic electrolyte abnormalities related to initiation of feeding requiring electrolyte and fluid replacement but it is expected that clinical re-feeding syndrome characterized by cardiac, pulmonary, neurological abnormalities will be absent; an opinion informed by the investigators' recent systematic review.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startMar 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Medical Organization of Southwestern Ontario
- Responsible party
- Sponsor
- Investigators
- Adam Rahman, MD, FRCPC, Principal investigator, St. Joseph's Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632630
- Sponsor's protocol ID
- INN15-007
- Acronym
- NutriSuP
- Status last verified
- Nov 2018
- First submitted
- 3 Dec 2015
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Mrkobrada M, Patel A, Chakroborty A, Handsor S, Armstrong D, Rahman A. NutriSup-PPN: A pilot randomized control trial of oral nutritional supplementation (ONS) and peripheral parenteral nutrition (PPN) in canadian, malnourished, hospitalized patients. Clin Nutr ESPEN. 2023 Feb;53:107-112. doi: 10.1016/j.clnesp.2022.04.008. Epub 2022 Apr 23.
PubMed 36657900
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Supplementation in Hospitalized Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02632630
- Acronym / sponsor ID
- NutriSuP / INN15-007
- Conditions
- Malnutrition
- Keywords
- Peripheral Parenteral Nutrition, Oral nutritional supplementation, Acute Care hospitals
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Academic Medical Organization of Southwestern Ontario
- Study start
- Mar 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 17 Dec 2015 (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.
Patients with severe malnutrition risk are 7.4 times more likely to die in hospital than well-nourished patients, and carry a 30-day readmission rate of >46%. Although malnutrition is common and is associated with extremely poor outcomes, it is neglected and undertreated. This is a randomized controlled pilot trial to rapidly identify at-risk hospitalized medical patients, and then provide nutritional supplementation in hospital and after discharge for 28 days. In select at-risk patients, 5 days of nutrition delivered through a peripheral vein will be used in addition to oral nutritional supplementation.
Detailed description
In this pilot trial, the feasibility of the trial protocol will be established in two centres in Canada. Patients at high risk of malnutrition will be identified within 48 hours of hospital admission using Subjective Global Assessment criteria. Patients will be randomized in a factorial design fashion via a centralized, internet-based randomization protocol to one of the following arms:
- Peripheral parenteral nutrition and enhanced oral supplementation;
- Peripheral parenteral nutrition and standard care for oral supplementation;
- Standard care for parenteral fluid administration and enhanced oral supplementation;
- Standard care for parenteral fluid administration and standard of care for oral supplementation.
Peripheral parenteral nutrition (PPN) is intravenous nutrition consisting of dextrose, amino acids, fat, and electrolytes through a peripheral vein. Peri-OLIMEL 2.5% E, parenteral solution (Baxter) will be administered in this study. Patients will be randomized to PPN vs. standard care intravenous maintenance fluid administration for up to 5 days of hospitalization or until discharge, whichever is sooner. The PPN will be administered in place of their maintenance crystalloid solution, and will be adjusted or stopped as clinically indicated by the attending medical team.
If there is no maintenance crystalloid fluid administration, the parenteral nutrition solution will be administered at a rate of 0.85mL/kg/hour.
The minimum infusion rate will be 45 mL per hour (for participants who weigh 53 kg or less). The minimum infusion rate would provide a supplementation of 1,080 kcal/day.
The maximum infusion rate will be 85 mL/hour (for participants who weigh 100 kg or more). The maximum infusion rate would provide a supplementation of 2,040 kcal/day.
The PPN solution has a low osmolarity (< 900 mOsm) to reduce risk of phlebitis (Peri-OLIMEL 2.5% E is760mOsm). The use of PPN, compared to total parenteral nutrition (TPN) offers safety advantages. PPN avoids cost and complication of central line placement, avoids line sepsis and reduces the likelihood re-feeding syndrome [30-32]. Peri-OLIMEL 2.5% E contains lipids and electrolytes further reducing the likelihood of vein irritation and refeeding syndrome. All patients will be monitored closely and patients with uncontrolled blood sugars will be excluded.
Patients randomized to Oral Nutritional Supplementation (ONS) will receive standard menu or standard menu plus oral nutritional supplements. The investigators will provide patients with one package of ONS (Resource 2.0 - 237 mL, 474 calories; or similar product) two times daily in hospital. Although the patient will be encouraged, they will not be required to consume all of the oral supplementation product. Upon discharge, patients will be provided with ONS product to take home.
All participants will be monitored daily in hospital. After discharge, the investigators will follow up with the participant at a 30-day follow-up clinic visit, to collect data regarding clinical outcomes, quality of life, physical function, and nutrition-related variables.
This pilot study will establish the feasibility of a paradigm-changing protocol that will rapidly identify and aggressively treat malnutrition in hospitalized patients, with the goal of improving function, quality of life, healthcare utilization, and reducing the risk of adverse clinical events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Amino Acids w/Electrolytes in Dextrose | Active comparator | Drug: Amino Acids w/Electrolytes in DextrosePeripheral parenteral nutrition (PPN) |
| Ensure product | Active comparator | Dietary Supplement: Ensure productCalorie and protein dense oral nutritional supplement for patients with elevated nutritional needs. |
| Crystalloid solutions | Active comparator | Drug: Crystalloid solutionsStandard care intravenous maintenance fluids. |
| Oral nutritional supplementation | Active comparator | Dietary Supplement: Oral nutritional supplementationNutrient-enhanced drink products that provide macronutrients and micronutrients with the aim of increasing oral nutritional intake. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjective Global Assessment (SGA) category B or C.
- Have been hospitalized for less than 48 hours.
Key exclusion criteria (7 listed)
- Have an allergy or intolerance to any component of the oral supplement or parenteral nutrition.
- Have a contraindication to administration of IV fluid (i.e. are in volume overloaded state, are being given IV furosemide).
- Are currently suffering from refeeding syndrome.
- Have a pre-existing medical condition that prevents oral intake of full fluids.
- Have a diagnosis or suspicion of septic shock.
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 |
|---|---|---|
| Amino Acids w/Electrolytes in DextroseAlso: Peri-OLIMEL 2.5% E (Baxter)Patients will receive peripheral parenteral nutrition to a maximum of 2L/day (with a minimum rate of 45mL/hour and a maximum rate of 85mL/hour) of pre-packaged Peri-OLIMEL 2.5% E. The PPN will be administered in place of their maintenance crystalloid solution, and will be adjusted or stopped as clinically indicated by the attending medical team., for up to 5 days of hospitalization or until discharge, whichever is sooner. | Drug | Amino Acids w/Electrolytes in Dextrose |
| Ensure productPatients will receive one package of Ensure two times daily in hospital. At discharge, patients randomized to receive Ensure will be provided with 28 packages of Ensure with instructions to attempt to consume 1 package per day. | Dietary supplement | Ensure product |
| Crystalloid solutionsAlso: normal saline, dextrose, lactated Ringer'sStandard care intravenous maintenance fluid administration for up to 5 days of hospitalization or until discharge, whichever is sooner. | Drug | Crystalloid solutions |
| Oral nutritional supplementationStandard of care oral nutritional supplementation is determined by the clinician. A dietitian may also be involved. | Dietary supplement | Oral nutritional supplementation |
Primary outcome
Successful participant recruitment
Time frame: 12 months
This pilot study will demonstrate feasibility of recruitment if investigators are able to recruit 100 participants over 12 months. A total recruitment of 15 patients/month is considered as reasonable given the high numbers of competing studies, missed patients, and consent failure rates.
2 secondary outcomes
Adherence to treatment
Time frame: 30 days
Number of participants to experience clinical re-feeding syndrome.
Time frame: 30 days
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 6 Nov 2018.
- Derived from this study: PubMed 36657900Mrkobrada M, Patel A, Chakroborty A, Handsor S, Armstrong D, Rahman A. NutriSup-PPN: A pilot randomized control trial of oral nutritional supplementation (ONS) and peripheral parenteral nutrition (PPN) in canadian, malnourished, hospitalized patients. Clin Nutr ESPEN. 2023 Feb;53:107-112. doi: 10.1016/j.clnesp.2022.04.008. Epub 2022 Apr 23.
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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.
Adam Rahman, MD, FRCPC principal investigator
St. Joseph's Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amino Acids w/Electrolytes in Dextrose, Ensure product and Crystalloid solutions in people with Malnutrition, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 7 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 6 Nov 2018. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Successful participant recruitment (time frame: 12 months). 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 NCT02632630, which also lists 1 linked publication.
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 6 Nov 2018.