Efficacy of Enteral Glutamine Supplementation in Patients With Predicted Severe Acute Pancreatitis- A Double-Blinded Randomized Controlled Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Asian Institute of Gastroenterology, India
Sponsor:
Information provided by (Responsible Party):
Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier:
NCT01503320
First received: January 1, 2012
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

Acute pancreatitis (AP) is a potentially serious illness characterized by inflammation of the pancreas with variable involvement of peri-pancreatic tissues and/ or remote organ systems. AP is hyper catabolic condition due to systemic inflammatory response syndrome (SIRS without any proven specific treatments. Therefore, current therapy for AP is directed to intensive medical care, nutrition support and infection control.

Nutritional support is very crucial in the treatment of AP. Enteral nutrition (EN) is the preferred modality since parenteral nutrition is associated with various complications. EN could preserve the intestinal permeability, which would be the best barrier for prevention of certain complications.

Glutamine is the most abundant free amino acid in the body and is used as a major fuel and nucleotide substrate. When a nutritional deficiency arises in critical illness including SAP, glutamine tends to be conditionally depleted.

We hypothesize that enteral glutamine supplementation in patients with severe and predicted severe acute pancreatitis helps in their early recovery and prevention of adverse outcomes.

In this study, we aim to evaluate the therapeutic effect of enteral glutamine on clinical outcomes, gut permeability, systemic inflammation, oxidative stress and plasma glutamine levels.


Condition Intervention
Acute Pancreatitis
Dietary Supplement: Enteral glutamine
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Asian Institute of Gastroenterology, India:

Primary Outcome Measures:
  • Development of infected (peri)pancreatic necrosis [ Time Frame: Baseline; 7 days; 6 months ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: Baseline; 7 days; 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in levels of HS- CRP. [ Time Frame: Baseline, 7 days, 14 days ] [ Designated as safety issue: No ]
  • Change in mucosal permeability [ Time Frame: Baseline, 7 days, 14 days ] [ Designated as safety issue: No ]
  • Change in level of oxidative stress [ Time Frame: Baseline, 7 days, 14 days ] [ Designated as safety issue: No ]
  • Change in cytokine levels in serum [ Time Frame: Baseline, 7 days, 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enteral glutamine Dietary Supplement: Enteral glutamine
Dosage of glutamine: 0.57g/kg, ~ 30g/day= 3sachets
Placebo Comparator: Placebo Dietary Supplement: Placebo
Similar appearing nutritional supplement without glutamine.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients over the age 18.
  • Patient admitted within 72hrs of onset of abdominal pain for over 24hr with raised (>3- fold) serum lipase/amylase on admission.
  • Marshall Score of ≥ 2 in any one organ, excluding the liver component
  • Pancreatic necrosis >30% on Computed tomography (CT) scan or a modified CT severity index of ≥6.
  • Apache II score ≥8.
  • BUN at admission of >20mg/dL or an BUN elevation of >5mg/dL within 48hrs of admission.

Exclusion Criteria:

  • Patients with chronic pancreatitis and pancreatic insufficiency requiring pancreatic enzyme supplements.
  • Pre-existing chronic renal insufficiency requiring hemodialysis or peritoneal dialysis.
  • Patients with ARF.
  • Pre-existing end-stage liver disease with ascites, coagulopathy and encephalopathy.
  • Pancreatic cancer.
  • Current somatostatin or corticosteroid therapy.
  • Any form of artificial feeding since commencement of acute pancreatitis symptoms.
  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: NCT01503320

Contacts
Contact: Rupjyoti Talukdar, MD +91-40-23378888 rup_talukdar@yahoo.com

Locations
India
Asian Institute of Gastroenterology Active, not recruiting
Hyderabad, Andhra Pradesh, India, 500082
Asian Institute of Gastroenterology Recruiting
Hyderabad, Andhra Pradesh, India, 500082
Contact: Rupjyoti Talukdar, MD    +914023378888    rup_talukdar@yahoo.com   
Principal Investigator: Rupjyoti Talukdar, MD         
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
Investigators
Principal Investigator: Rupjyoti Talukdar, MD Asian Institute of Gastroenterology
  More Information

No publications provided

Responsible Party: Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT01503320     History of Changes
Other Study ID Numbers: AIG-GI-2011-05
Study First Received: January 1, 2012
Last Updated: July 10, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Asian Institute of Gastroenterology, India:
To evaluate
efficacy
enteral glutamine

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 28, 2014