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临床试验/CTRI/2024/02/062750
CTRI/2024/02/062750尚未招募2 期

Evaluation of impact of intra- abdominal hypertension on outcome in patients of acute pancreatitis and comparative study between step up approach and simultaneous approach for management of reduction of IAP in patients of acute pancreatitis with IAH: A randomised control study

Dr. Jayanta samanta1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年3月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
1. The percentage difference in the reduction of IAP at 72 hrs between step up approach and simultaneous approach for management of IAH

研究概览

简要总结

Patients with SAP tend to have elevated intra- abdominal pressure (IAP), which can lead to intra- abdominal hypertension (IAH)  and subsequently to abdominal compartment syndrome (ACS). About 11–40 % of SAP patients suffer from complications of ACS. Incidence of IAH in patients of SAP varies from 60- 80%. The degree of IAP in patients with SAP seems to correlate with the degree of organ dysfunction, the severity of the disease, the length of the stay at hospital and mortality.  We have established in our previous studies that IAH is a poor outcome predictor and that reduction of IAP improves survival. Moreover, we have also established that failure of early reduction of IAP can lead to deleterious outcomes. Thus early detection and rapid treatment of IAH is key to improve outcome in AP patients with IAH. Interestingly, the key factors contributing to the development of IAH in AP include paralytic ileus leading to bowel distension, ascites, peripancreatic fluid collections, mesenteric inflammation, and abdominal pain in various combinations. The current strategy involves step wise intervention to address these factors in the form of minimally invasive techniques such as Ryle’s tube insertion and flatus tube insertion to start with and insertion of percutaneous catheter drain at a later phase in cases of non-improvement. However, it is imperative to note that time is key to obtain highest benefit from interventions to reduce IAP, as pointed above. Whether all the interventions applied simultaneously would benefit earlier or have better synergistic effects in reducing the IAP has not been studied.  Hence we planned this study to monitor IAP in patients of acute pancreatitis and to compare the two strategies of conventional step-up approach and a simultaneous approach for management of IAH in patients of acute pancreatitis in a randomised control trial.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patient’s age ≥ 18 years
  • Informed consent for participation in the study
  • All patients of acute pancreatitis presenting within 14 days of pain onset.
  • Presence of intra-abdominal hypertension as per the definition.

排除标准

  • History of arrhythmia Bronchial asthma pregnancy history of laparotomy prior endoscopic/radiological/surgical intervention lack of informed consent.

结局指标

主要结局

1. The percentage difference in the reduction of IAP at 72 hrs between step up approach and simultaneous approach for management of IAH

时间窗: 1. At the end of 72 hrs of intervention | 2. At the end of the index hospital admission

2. Composite outcome parameter of mortality, surgery, need for ventilator and development of new onset multiple organ failure

时间窗: 1. At the end of 72 hrs of intervention | 2. At the end of the index hospital admission

次要结局

  • a. Resolution of organ failure(b. Duration of organ failure)

研究者

发起方
Dr. Jayanta samanta
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Jayanta Samanta

PGIMER Chandigarh India

研究点 (1)

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