Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients (TOP-UP)

NCT01206166 | Terminated Phase 3 Results

• 1 other identifier: TOP-UP
• Study Type: interventional
• Target: 125
• Locations: 4 countries
• Sites: 12

Brief 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 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.

Conditions

Critical Illness; Acute Respiratory Failure

Keywords

Randomized trial; Parental nutrition; Enteral nutrition; Intensive care unit; BMI < 25 or ≥ 35

Outcome Measures

Primary Outcomes (2)

• Calorie & Protein Intake 7 Days Post Randomization

  Amount of calories \& protein received as a percentage of prescribed.

  7 days post randomization

• Calorie & Protein Intake in First 27 Days

  Amount of calories \& protein received as a percentage of prescribed.

  first 27 days

Secondary Outcomes (28)

• 6 Month Mortality

  6 months

• ICU Mortality

  6 months

• Hospital Mortality

  6 months

• Duration of ICU Stay

  6 months

• Duration of Hospital Stay

  6 months

Study Arms (2)

Enteral Nutrition + Parenteral Nutrition

EXPERIMENTAL

Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).

Drug: Olimel (5.7%E / N9E)

Enteral Nutrition Only

NO INTERVENTION

Enteral nutrition only - no intervention

Interventions

Olimel (5.7%E / N9E) DRUG

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.

Also known as: Olimel

Enteral Nutrition + Parenteral Nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \>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)
• 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

Sponsors & Collaborators

• Clinical Evaluation Research Unit at Kingston General Hospital: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (12)

University of Colorado DHSC

Boulder, Colorado, 80045, United States

Location

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110-1093, United States

Location

Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

Location

Cleveland Clinic Lerner College of Medicine

Cleveland, Ohio, 44195, United States

Location

The Ohio State Univsersity Medical Center

Columbus, Ohio, 43221, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

Location

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

Erasme University Hospital

Brussels, B - 1070, Belgium

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

University of Alberta

Edmonton, Alberta, T5H 3V9, Canada

Location

Grey Nuns Hospital

Edmonton, Alberta, T6L 5X8, Canada

Location

Nouvel Hôpital Civil

Strasbourg, F - 67091, France

Location

Related Publications (6)

• 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.

  PMID: 19572118 BACKGROUND

• Villet 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.

  PMID: 15899538 BACKGROUND

• Krishnan 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.

  PMID: 12853537 BACKGROUND

• Hise 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.

  PMID: 17324665 BACKGROUND

• Dhaliwal 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.

  PMID: 15185069 BACKGROUND

• Wischmeyer 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.

  PMID: 28599676 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

due to slower than anticipated enrollment and the upcoming end of the funding from the National Institutes of Health the study was prematurely terminated

Results Point of Contact

• Title: Dr.Daren Heyland
• Organization: CERU Queen's University

dkh2@queensu.ca

403-915-5573

Study Officials

• Daren K. Heyland, MD

  Clinical Evaluation Research Unit, Kingston General Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 21, 2010
• Study Start: June 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 16, 2021
• Results First Posted: March 16, 2021

Record last verified: 2021-02

Locations

CA (3); BE (1); FR (1); US (7)