To Study The effectivenes of Goal-Directed fluid therapy in treatment of Acute Pancreatitis VS Standard IV Fluid Therapy :A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To study the effectiveness of goal directed fluid therapy in management of acute pancreatitis.
研究概览
简要总结
In India, Acute pancreatitis (AP) is on of the most common diseases in middle aged population .Prevalence is 7.9 per 1 lac. For men 8.6 and for women 8 per lac i.
Incidence rate of acute pancreatits is increasing since six decades because of increased alcohol consumption and lifestyle changes in young generation in India .Other causes include gall stones ,idiopathic and drug induced acute pancreatitis ii.Although the majority of clinical presentations of AP is mild in severity ,20-25%develop moderate to severe pancreatitis due to overwhelming SIRS and MOF.iii
There is currently no effective pharmacological treatment available to treat AP. Mainstay of treatment is Fluid and electrolyte balance as a supportive management .Despite the significant importance of this fluid therapy ,there is lack of information on Optimal Fluid Therapy .There are many RCTs in world literature regarding the rate and volume and type of fluid therapy but with conflicting evidence . There are many studies with Moderate fluid therapy ivas well as Aggressive Fluid Therapy but both are ineffective and with many complications as well .Given that the disease severity is variable at presentation ,goal directed fluid therapy (GDFT),has been suggested to guide IV Fluids resuscitation in AP .There are many trials for AP, which are based on biochemical measures but have failed to show reduction in treating SIRS and MOF. Randomized control Trials based on hemodynamic measures such as stroke volume and cardiac output have shown to be more effective in decreasing morbidity and mortality in AP. The British Medical Journal has published a study in 2019, Ward – based Goal Directed Fluid Therapy (GDFT) in Acute Pancreatitis (GAP) trial ,where Optimal Fluid Volume is administered in first 48 hours (Golden period for management ) by measuring CO and SV on non invasive cardiac monitors .Results of this study are promising .It has concluded that the study is feasible ,safe ,acceptable by patients and clinicians ,and have less complications of AP, with fewer ICU admissions ,hence less expensive with decreased morbidity and mortality .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients admitted to MGM medical hospital Aurangabad Maharashtra , with Acute pancreatitis international consensus criteria VII (any 2 of 3) 1)classical pain in abdomen (acute onset of severe epigastric pain ,generally radiating to back) 2) Increase in serum amylase and lipase levels higher than three times the upper limit of normality 3)Signs of Acute pancreatitis on imaging (C T or USG).
排除标准
- •Chronic pancreatitis in which acute exacerbation cannot be confirmed.
- •History of any fluid overload diseases like cardiac failure ,abdominal hypertension ,pleural effusion in the past three months .
- •Unable to provide informed and written consents.
结局指标
主要结局
To study the effectiveness of goal directed fluid therapy in management of acute pancreatitis.
时间窗: Baseline(0) 4 hours 8 hours 12 hours 16 hours 20 hours 24 hours 28 hours 32hours 36 hours 40hr 44hours and 48hours with follow up post 48hour period until the end of 1st month
次要结局
- 1) To study an assessment of feasibility of trial in India(2)To calculate optimal fluid requirement in management of pancreatitis)
研究者
Dr Isha Kedia
MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD