The Impact of Preoperative Oral Glutamine Intake on the Immunocompetence and Outcomes of Malnourished Patients Undergoing Major Abdominal Surgery Due to Malignancies

• Status: Completed
• Trial end date: 2018-02-12
• Target enrollment: 0
• Participant gender: All

Summary

Malnutrition occurs in up to 50% of patients requiring elective surgery for neoplastic diseases. It exerts a detrimental influence on outcome of surgery, because it can suppress immune function, exaggerate stress response and cause organ system dysfunction. Increased susceptibility to infection, protracted wound healing, impaired blood clotting and vessel wall fragility have been shown to be the leading causes of postoperative morbidity and mortality in malnourished patients undergoing major surgical resections.

This trial is designed as a prospective randomized, double-blinded, placebo-controlled pilot study in a academic single center in Switzerland. A total of 50 malnourished patients with gastro-intestinal tumors will receive orally glutamine or placebo-treatment during a period of 5 days prior to surgery. The investigators hypothesize that oral Glutamine administration is feasible, well tolerated, will decrease postoperative morbidity, will suppress postoperative cell damage and inflammatory response, and will improve the perioperative immunocompetence of the patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborator: Fresenius Kabi

Criteria

Inclusion Criteria:

• Histologically confirmed and surgically resectable carcinomas

• Candidates for elective surgery with an estimated surgical stress score

• A Nutritional Risk Screening 2002 (NRS-200232) score ≥3

• Age ≥ 18 years

• Completed primary immunization with tetanus toxoid

• Last tetanus booster ≥10 years back

• Informed consent

Exclusion Criteria

• Refusal to participate

• Clinically relevant alterations of the pulmonary renal of hepatic function

• Insulin-dependent diabetes mellitus

• Pre-existing autoimmune diseases and immune-deficiencies

• Neutropenia

• Pregnancy

• Age <18 years

• Last tetanus booster <10 years back

• Ongoing infection

• Intestinal obstruction at the time of entry into the study