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NCT Number: NCT01568853

A Prospective Study of The Complement Depletion in Patients With Severe Abdominal Sepsis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of severe abdominal sepsis

Exclusion criteria

  • Age < 18 or > 60 years
  • Pregnancy
  • Leucopenia from radiochemical therapy due to malignant tumor
  • Any primary diagnosis other than sepsis
  • Confirmed immunodeficiency
  • Requirement for blood transfusion, plasmapheresis, or immediate surgery

Treatment and study plan

norepinephrine

Drug

Intravenously, 10 ug/min, 24 hours

Open abdomen

Procedure

IAH >=20 mmHg, and ACS emerged, such as low urine and decreased FiO2 quickly.

Enteral nutrition

Other

500-1500 kcal/day; Nasogastric tube feeding;

Other names: Peptison (SP; Nutricia, Shanghai, China)

Parenteral nutrition

Other

3000 mL parenteral nutrition fluid, intravenously.

Other names: Made by our hospital.

Primary outcomes

  1. All cause mortality

    Time frame: within the first 28 days after admission to our hosptial

    Patients died within the first three days of admission would be excluded from this study.

Secondary outcomes

  1. Postoperative complications

    Time frame: within the first 28 days after admission to our hosptial

    wound complications; pulmonary infection; incisional hernia, and bleeding.

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Registry information

Official study title

The Complement C3 Depletion in Patients With Severe Abdominal Sepsis: Risk Prediction and the Association With Down-regulated Adaptive Immunity

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 2, 2012
Registry last updated
Apr 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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