Fluid Collections Management in Severe Acute Pancreatitis (FCMSAP)
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|ClinicalTrials.gov Identifier: NCT01321060|
Recruitment Status : Unknown
Verified January 2011 by Weiqin Li, Nanjing University School of Medicine.
Recruitment status was: Recruiting
First Posted : March 23, 2011
Last Update Posted : June 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Acute Pancreatitis Acute Pancreatic Fluid Collection||Procedure: Aspiration Procedure: Catheter drainage Drug: Conservative treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||87 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Management of Sterile Fluid Collections in Patients With Severe Acute Pancreatitis:a Randomized Controlled Trial|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2012|
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.
- pancreatic infection [ Time Frame: 28 days ]
- mortality [ Time Frame: 28 days ]
- inflammation parameters [ Time Frame: 28 days ]
- intra abdominal pressure [ Time Frame: 28 days ]
- complications [ Time Frame: 28 days ]intestinal fistula , major bleeding, etc.
- ICU duration [ Time Frame: day one until discharge ]
- hospital duration [ Time Frame: day one until discharge ]
- SIRS [ Time Frame: 28 days ]
- MODS [ Time Frame: 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321060
|Contact: Weiqin Li, Dremail@example.com|
|Contact: Zhihui Tong, Drfirstname.lastname@example.org|
|Department of SICU, Research Institute of General Surgery Jinling Hospital,||Recruiting|
|Nanjing, Jiangsu, China, 210002|
|Contact: Weiqin Li, Dr +86-025-80860066 email@example.com|
|Principal Investigator: Weiqin Li, Dr|