Fluid Collections Management in Severe Acute Pancreatitis (FCMSAP)
Recruitment status was Recruiting
Acute fluid collections is common in patients with severe acute pancreatitis (SAP). But the treatment for this is controversial. In this study, the investigators aim to evaluate the different effects of three different treatment protocols which is repeated aspiration, continuous catheter drainage and conservative treatment. The investigators suppose repeated aspiration could not only solve acute fluid collections, but also lower the rate of pancreatic infection.
Acute Pancreatic Fluid Collection
Procedure: Catheter drainage
Drug: Conservative treatment
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Management of Sterile Fluid Collections in Patients With Severe Acute Pancreatitis:a Randomized Controlled Trial|
- pancreatic infection [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- inflammation parameters [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- intra abdominal pressure [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- complications [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]intestinal fistula , major bleeding, etc.
- ICU duration [ Time Frame: day one until discharge ] [ Designated as safety issue: No ]
- hospital duration [ Time Frame: day one until discharge ] [ Designated as safety issue: No ]
- SIRS [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- MODS [ Time Frame: 28 days ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Conservative treatment
Conservative treatment group with only drugs.
Drug: Conservative treatment
Including antibiotics,somatostatin, proton pump inhibitors and sufficient fluid resuscitation
Experimental: Continuous catheter drainage
Once the diameter of the fluid collection is more than 6cm, continuous catheter drainage will be applied.
|Procedure: Catheter drainage|
Experimental: Repeated aspiration
Once the diameter of the fluid collection is more than 6cm, aspiration is applied and draw the tube out immediately after aspiration.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321060
|Contact: Weiqin Li, Drfirstname.lastname@example.org|
|Contact: Zhihui Tong, Dremail@example.com|
|Department of SICU, Research Institute of General Surgery Jinling Hospital,||Recruiting|
|Nanjing, Jiangsu, China, 210002|
|Contact: Weiqin Li, Dr +86-025-80860066 firstname.lastname@example.org|
|Principal Investigator: Weiqin Li, Dr|