NCT01503320

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

2.8 years

First QC Date

January 1, 2012

Last Update Submit

June 3, 2015

Conditions

Acute Pancreatitis

Keywords

To evaluateefficacyenteral glutamine

Outcome Measures

Primary Outcomes (2)

  • Development of infected (peri)pancreatic necrosis

    Baseline; 7 days; 6 months

  • Mortality

    Baseline; 7 days; 6 months

Secondary Outcomes (4)

  • Change in levels of HS- CRP.

    Baseline, 7 days, 14 days

  • Change in mucosal permeability

    Baseline, 7 days, 14 days

  • Change in level of oxidative stress

    Baseline, 7 days, 14 days

  • Change in cytokine levels in serum

    Baseline, 7 days, 14 days

Study Arms (2)

Enteral glutamine

EXPERIMENTAL
Dietary Supplement: Enteral glutamine

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Enteral glutamineDIETARY_SUPPLEMENT

Dosage of glutamine: 0.57g/kg, \~ 30g/day= 3sachets

Enteral glutamine
PlaceboDIETARY_SUPPLEMENT

Similar appearing nutritional supplement without glutamine.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Andhra Pradesh, 500082, India

Location

Related Publications (1)

  • Arutla M, Raghunath M, Deepika G, Jakkampudi A, Murthy HVV, Rao GV, Reddy DN, Talukdar R. Efficacy of enteral glutamine supplementation in patients with severe and predicted severe acute pancreatitis- A randomized controlled trial. Indian J Gastroenterol. 2019 Aug;38(4):338-347. doi: 10.1007/s12664-019-00962-7. Epub 2019 Oct 14.

    PMID: 31612309DERIVED

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Rupjyoti Talukdar, MD

    Asian Institute of Gastroenterology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2012

First Posted

January 4, 2012

Study Start

January 1, 2012

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

IN(1)