Status:
TERMINATED
Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients (TOP-UP)
Lead Sponsor:
Clinical Evaluation Research Unit at Kingston General Hospital
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Critical Illness
Acute Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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 morbid...
Eligibility Criteria
Inclusion
- 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
Exclusion
- \>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
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT01206166
Start Date
June 1 2011
End Date
July 1 2015
Last Update
March 16 2021
Active Locations (12)
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1
University of Colorado DHSC
Boulder, Colorado, United States, 80045
2
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63110-1093
3
Mercy Hospital St. Louis
St Louis, Missouri, United States, 63141
4
Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, United States, 44195