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

NCT01552291 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-02-13

No results posted yet for this study

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.

Conditions

  • Malnourishment
  • Gastrointestinal Tumors

Interventions

DIETARY_SUPPLEMENT

Glutamine

30g oral glutamine / day for 5 days before surgery. Glutamine is an important nonessential amino acid and its intracellular concentration is much higher than that of other amino acids. Glutamine is released in large quantities from skeletal muscle and serves as an important carrier and donor of nitrogen

DRUG

Placebo

30g oral maltodextrin / day for 5 days before surgery

Sponsors & Collaborators

  • Fresenius Kabi

    collaborator INDUSTRY

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Beat Schnüriger, PD Dr. med. · Department of visceral surgery and transplant surgery, Berne University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2018-02-10
Completion
2018-02-12

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01552291 on ClinicalTrials.gov