An interventional study of Norepinephrine and Open abdomen in Severe Sepsis, Pancreatitis and Abdominal Abscess, sponsored by Jinling Hospital, China. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-04-06.
Sponsored by Jinling Hospital, China · Not applicable, Interventional, and Screening
The role of complement system in bridging innate and adaptive immunity has been confirmed in various invasive pathogens. The aim of this study is to investigate the alteration of complement C3 in patients with severe abdominal sepsis and evaluate the role of complement C3 depletion in prognosis of such patients. The relationship between complement C3 depletion and adaptive immunity is studied meanwhile.
Severe abdominal sepsis remains a significant cause of death in patients undergoing intra-abdominal infection, in despite of recent declines in overall mortality. There is a abundant evidence to suggest complement activation during sepsis. While there is great interest in complement by-products in human sepsis, few studies focus on the persistent consumption of complement components and its role in prognosis of sepsis. Complement C3 is indispensable community pathway for complement activation. In a way, the alteration of C3 levels can affect the whole status of complement biological functions.
In clinical practice, the severe abdominal sepsis would develop compromised immune function if the intra-abdominal infection is not well controlled. The down-regulated T- and B-cell immune responses to sepsis are correlated to the decreased immune defense. To our knowledge, there are few human data that have investigated the relationship between complement depletion and adaptive immunity in severe abdominal sepsis. The investigators hypothesize that the complement C3 depletion during sepsis has a stronger association with the down-regulated adaptive immunity and can be regarded as a essential risk factor to predict the prognosis of such critical illness.
The purpose of this prospective study is two-fold. First, the investigators observe, in a cohort of patients with severe abdominal sepsis, the levels of complement components and percentages of T cell subsets after admission to evaluate the relationship between complement system and adaptive immunity. Second, the investigators also evaluate the application of the C3 related-indexes (C3, C3a, Factor H, DAF, etc.) to patients undergoing severe abdominal sepsis and to develop an alternative model to predict its prognosis.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's enrollment of 75 is below the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →Jinling Hospital, China is the lead sponsor of 131 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
Intravenously, 10 ug/min, 24 hours
IAH \>=20 mmHg, and ACS emerged, such as low urine and decreased FiO2 quickly.
500-1500 kcal/day; Nasogastric tube feeding;
Also known as: Peptison (SP; Nutricia, Shanghai, China)
3000 mL parenteral nutrition fluid, intravenously.
Also known as: Made by our hospital.
All cause mortality
Patients died within the first three days of admission would be excluded from this study.
Time frame: within the first 28 days after admission to our hosptial
Postoperative complications
wound complications; pulmonary infection; incisional hernia, and bleeding.
Time frame: within the first 28 days after admission to our hosptial
The record gives a start of Nov 2011, a primary completion of Mar 2012 and a completion of Mar 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Norepinephrine