跳至主要内容
临床试验/NCT01503320
NCT01503320已完成不适用

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

Asian Institute of Gastroenterology, India2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Development of infected (peri)pancreatic necrosis

研究概览

简要总结

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.

详细描述

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 contributes to thousands of annual hospital admissions, of which severe acute pancreatitis (SAP) accounts for 10-20%. The course of SAP tends to be prolonged and the patients usually are hyper metabolic and high protein catabolic due to systemic inflammatory response syndrome (SIRS) induced by acute local inflammatory process and subsequent vital organ dysfunction. There are currently no specific proven treatments. Therefore, current therapy for AP is directed to intensive medical care, nutrition support, infection control and medicine administration.

Nutritional support plays an important role in the management of patients with SAP, which is very critical and complex. Thus, if nutritional support is not appropriately administered to match the rapidly increasing demand in the treatment of SAP, the patients consequently come down with gross metabolic imbalance and nutrition deficiency. This is considered to increase mortality due to impaired immune function, increased risk of infections and intractable vital- organ failure.

Despite the recently reported encouraging results on early enteral feeding in patients with acute pancreatitis, total parenteral nutrition (TPN) is still frequently performed in the management of patients with AP. However, longer periods of TPN are known to be associated with mucosal atrophy and increased gastrointestinal permeability, two established risk factors for endotoxemia and bacteriemia.

Artificial nutrition can prevent complications and provide long term nutritional support for SAP patients. Enteral nutrition is preferred to parenteral nutrition for improving patient outcomes and has largely replaced the parenteral route. Early nasogastric enteral nutrition (NGEN) was considered potentially to lead to pancreatic-unrest and thereby prove to be harmful to the early acute phase of AP. However, Eatock et al introduced the early nasogastric feeding into the nutritional management of SAP and Pandey et al applied oral re-feeding in patients with SAP, suggesting that the nasogastric feeding is feasible in up to 80% cases. A meta-analysis and a recent randomized controlled trial showed that early NGEN would be as effective and safe as early Naso Jejunal enteral nutrition (NJEN) or TPN in SAP patients, without increase in mortality and pain on re-feeding.

EN could preserve the intestinal permeability, proven by the assessment of excretion of polyethylene glycol and antiendotoxin core antibody IgM levels, which would be the best barrier for prevention of certain complications. Serum interleukin-6 levels are elevated very early in patients with necrosis infection and C-reactive protein (CRP) is considered a valuable independent predictor of mortality. IL-6 and CRP levels play a similar role in the control of systematic inflammatory response of early EN and TPN groups at each time point. Moreover, biochemical/ nutritional parameters such as serum albumin and prealbumin concentration in early EN are well preserved without any significant difference.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over the age
  • 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 ≥
  • Apache II score ≥
  • BUN at admission of >20mg/dL or an BUN elevation of >5mg/dL within 48hrs of admission.

排除标准

  • 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.

结局指标

主要结局

Development of infected (peri)pancreatic necrosis

时间窗: Baseline; 7 days; 6 months

Mortality

时间窗: Baseline; 7 days; 6 months

次要结局

  • 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)

研究者

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other
责任方
Sponsor

研究点 (2)

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