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Trial record 76 of 1120 for:    Oral Cancer | ( Map: Canada )

Oral Versus Parenteral Nutrition Support to Improve Protein Balance in Colorectal Surgical Patients

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ClinicalTrials.gov Identifier: NCT01222208
Recruitment Status : Completed
First Posted : October 18, 2010
Last Update Posted : February 7, 2012
Sponsor:
Collaborators:
Montreal General Hospital
McGill University
Information provided by (Responsible Party):
Franco Carli, McGill University Health Center

Brief Summary:
A prospective, randomized controlled study, using stable isotope methodology, is proposed to determine whether an oral nutrition support regimen, containing pressurized whey protein and glucose, is more effective at normalizing the metabolic response to surgery than a standard peripheral parenteral nutrition (PPN) support regimen, containing amino acids and glucose, in colorectal surgical patients studied before and after surgery. The effectiveness of the nutrition support regimens will be determined by: whole body protein balance, synthesis rates of hepatic secretory proteins, resting energy expenditure and substrate utilization, as well as circulating metabolites concentrations.

Condition or disease Intervention/treatment Phase
Colon Cancer Dietary Supplement: Oral Nutrition with dextrose and pressurized whey protein Dietary Supplement: Peripheral Parenteral Nutrition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Oral Versus Parenteral Perioperative Nutrition Support to Improve Protein Balance: Stable Isotope Study in Colorectal Surgical Patients
Study Start Date : March 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

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Arm Intervention/treatment
Active Comparator: Oral Nutrition
Subjects will receive an oral nutrition regimen comprised of 50% of their Resting Energy Expenditure (REE) as dextrose and 20% of their REE as pressurized whey protein
Dietary Supplement: Oral Nutrition with dextrose and pressurized whey protein
Ten (10) subjects will be randomly assigned to receive an oral nutrition regimen comprised of 50% of their REE as dextrose and 20% of their REE as pressurized whey protein. Subjects will undergo a six-hour stable isotope infusion protocol one day before surgery (to obtain baseline data) and on the first post-operative day. During both infusion protocols, subjects will be asked to carry out their assigned oral nutrition regimen. To minimize fasting during the perioperative period all subjects will receive peripheral parenteral nutrition (PPN) at the time of surgical incision until the first postoperative day.

Placebo Comparator: Peripheral Parenteral Nutrition
Subjects will receive a peripheral parenteral nutrition (PPN) regimen comprised of 50% of their Resting Energy Expenditure (REE) as dextrose and 20% of their REE as amino acids.
Dietary Supplement: Peripheral Parenteral Nutrition
Ten (10) subjects will be randomly assigned to receive peripheral parenteral nutrition (PPN) regimen comprised of 50% of their REE as dextrose and 20% of their REE as amino acids. Subjects will undergo a six-hour stable isotope infusion protocol one day before surgery (to obtain baseline data) and on the first post-operative day. During both infusion protocols, subjects will be asked to carry out their assigned PPN regimen. To minimize fasting during the perioperative period all subjects will receive PPN at the time of surgical incision until the first postoperative day.




Primary Outcome Measures :
  1. Whole body protein balance [ Time Frame: 1 year ]
    Whole body protein balance (the difference between protein synthesis and protein breakdown) as assessed by the kinetics of a stable, non-radioactive, isotope tracer infusion of L-[1-13C] leucine


Secondary Outcome Measures :
  1. Synthesis rates of hepatic secretory proteins [ Time Frame: 1 year ]
    Synthesis rates of hepatic secretory proteins, including the classically positive acute phase reactant fibrinogen and the classically negative acute phase reactant albumin, as assessed by incorporation of the stable, non-radioactive, isotope tracer L-[2H5] phenylalanine into plasma Very Low Density Lipoprotein ApolipoproteinB100.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The American Society of Anesthesiologists' (ASA) class 1 to 3
  2. Colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total, and hemicolectomy)
  3. Nutrition status: 18.5 < body mass index < 30 kg/m2, stable weight over the preceding three months (< 10% body weight loss), serum albumin > 35g/l

Exclusion Criteria:

  1. History of hepatic failure (Child-Pugh score A-C and transaminases outside the normal range)
  2. Renal impairment (Serum Creatinine outside normal range)
  3. Cardiac failure (New York Heart Association (NYHA) classes I-IV)
  4. Hepatic, Renal, Cardiac transplant
  5. Endocrine disorders: diabetes type I & II, hyper and hypothyroidism
  6. Active inflammatory bowel or diverticular disease (Crohn's Disease, Ulcerative Colitis)
  7. Musculoskeletal or neuromuscular disease
  8. Anemia defined as hematocrit < 30, hemoglobin < 10 g/dl, albumin < 25 mg/dl
  9. Previous spine surgery or scoliosis limiting use of epidural
  10. Pregnancy
  11. Use of Steroids
  12. Milk protein allergy or intolerance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01222208


Locations
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Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
McGill University Health Center
Montreal General Hospital
McGill University
Investigators
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Principal Investigator: Franco Carli, M.D. McGill University Health Center

Publications of Results:
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Responsible Party: Franco Carli, Dr. Franco Carli, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01222208     History of Changes
Other Study ID Numbers: 10-106-GEN
First Posted: October 18, 2010    Key Record Dates
Last Update Posted: February 7, 2012
Last Verified: February 2012

Keywords provided by Franco Carli, McGill University Health Center:
Bowel resection