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

NCT ID: NCT01222208

Last Updated: 2012-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-11-30

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.

Conditions

Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Oral Nutrition with dextrose and pressurized whey protein

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: PLACEBO_COMPARATOR

Peripheral Parenteral Nutrition

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montreal General Hospital

OTHER

Sponsor Role: collaborator

McGill University

OTHER

Sponsor Role: collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Franco Carli

Dr. Franco Carli

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Franco Carli, M.D.

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

Montreal General Hospital

Montreal, Quebec, Canada

Countries

Canada

References

Schricker T, Meterissian S, Lattermann R, Adegoke OA, Marliss EB, Mazza L, Eberhart L, Carli F, Nitschman E, Wykes L. Anticatabolic effects of avoiding preoperative fasting by intravenous hypocaloric nutrition: a randomized clinical trial. Ann Surg. 2008 Dec;248(6):1051-9. doi: 10.1097/SLA.0b013e31818842d8.

Reference Type: RESULT

PMID: 19092350 (View on PubMed)

Other Identifiers

10-106-GEN

Identifier Type: -

Identifier Source: org_study_id