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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University Hospital Inselspital, Berne
Sponsor:
Collaborator:
Fresenius Kabi
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01552291
First received: March 5, 2012
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Malnourishment
Gastrointestinal Tumors
Dietary Supplement: Glutamine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
Official Title: The Impact of Preoperative Oral Glutamine Intake on the Immunocompetence and Outcomes of Malnourished Patients Undergoing Major Abdominal Surgery Due to Malignancies - A Randomized, Placebo-controlled Pilot Study

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Morbidity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative cell damage [ Time Frame: Up to seven days after surgery ] [ Designated as safety issue: No ]
  • Inflammatory response [ Time Frame: Up to seven days after surgery ] [ Designated as safety issue: No ]
  • Nutritional status [ Time Frame: Up to seven days after surgery ] [ Designated as safety issue: No ]
  • Perioperative immunocompetence [ Time Frame: Seven and one day(s) before surgery. Postoperative week 1 and 6. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Glutamin 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
Placebo Comparator: Placebo Drug: Placebo
30g oral maltodextrin / day for 5 days before surgery

Detailed Description:

Background

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.

Immuno- or pharmaconutrition, defined as enteral or parenteral nutritional therapy based on a variety of products, such as omega-3-fatty acids, glutamine, arginine, sulfur-containing amino acids, nucleotides and anti-oxidants, is thought to have beneficial effects on postoperative recovery in a wide variety of surgical patients. Studies have shown its clinical effectiveness in terms of reduced postoperative complications, shortening the hospital stay and reduced hospitalization costs. Torosian et al. showed that severely malnourished patients benefit from preoperative nutrition, which reduce postoperative complications by 20%.

Although there is clinical evidence for the administration of immunonutrition to patients in the perioperative period, our understanding of the optimal type and time of immunonutrition, the characteristics of patients that benefit most, as well as the immunological mechanisms responsible for its beneficial effect is limited.

Objective

To assess in malnourished cancer patients the effect of 30g oral glutamine/day (3 sachets KABI® glutamine, Fresenius Kabi/day) for a preoperative course of 5 days on:

  1. Postoperative morbidity (surgical site infections, pneumonia, sepsis, incidence of wound and fascial dehiscence, incisional hernia, anastomotic break down)
  2. Nutritional status of the patients
  3. Postoperative cell damage and inflammatory response
  4. Perioperative immunocompetence

Methods

Seven days before surgery, the patients will receive a tetanus booster shot and will be randomly enrolled in either the 'glutamine group' or into the 'placebo group'. The patients as well as the responsible surgeons will be blinded.

  • Patients in the 'glutamine group' will receive 30g oral glutamine / day for 5 days before surgery.
  • Patients in the 'control group' will receive 30g oral maltodextrin / day for 5 days before surgery.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552291

Contacts
Contact: Beat Schnueriger, MD +41 31 632 24 03 beat.schnueriger@insel.ch
Contact: Barbara Uhlmann +41 31 632 23 26 barbara.uhlmann@insel.ch

Locations
Switzerland
Department of visceral surgery and transplant surgery, Berne University Hospital Recruiting
Berne, Switzerland, 3010
Contact: Barbara Uhlmann, Study Nurse    +41 31 632 23 26    barbara.uhlmann@insel.ch   
Principal Investigator: Beat Schnüriger, Dr. med.         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Fresenius Kabi
Investigators
Principal Investigator: Beat Schnüriger, Dr. med. Department of visceral surgery and transplant surgery, Berne University Hospital
  More Information

No publications provided

Responsible Party: Dr. med. Beat Schnüriger, Insel University Hospital Berne
ClinicalTrials.gov Identifier: NCT01552291     History of Changes
Other Study ID Numbers: 170/11
Study First Received: March 5, 2012
Last Updated: February 10, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
Malnourishment
Gastrointestinal tumors
Immunocompetence

Additional relevant MeSH terms:
Nutrition Disorders
Malnutrition
Digestive System Neoplasms
Gastrointestinal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 19, 2014