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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jianan Ren, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT01568853
First received: March 29, 2012
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Severe Sepsis
Pancreatitis
Abdominal Abscess
Appendicitis
Digestive System Fistula
Drug: Norepinephrine
Procedure: Open abdomen
Other: enteral nutrition
Other: parenteral nutrition

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: The Complement C3 Depletion in Patients With Severe Abdominal Sepsis: Risk Prediction and the Association With Down-regulated Adaptive Immunity

Resource links provided by NLM:


Further study details as provided by Jinling Hospital, China:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: within the first 28 days after admission to our hosptial ] [ Designated as safety issue: No ]
    Patients died within the first three days of admission would be excluded from this study.


Secondary Outcome Measures:
  • Postoperative complications [ Time Frame: within the first 28 days after admission to our hosptial ] [ Designated as safety issue: No ]
    wound complications; pulmonary infection; incisional hernia, and bleeding.


Enrollment: 75
Study Start Date: November 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Norepinephrine
    Intravenously, 10 ug/min, 24 hours
    Procedure: Open abdomen
    IAH >=20 mmHg, and ACS emerged, such as low urine and decreased FiO2 quickly.
    Other: enteral nutrition
    500-1500 kcal/day; Nasogastric tube feeding;
    Other Name: Peptison (SP; Nutricia, Shanghai, China)
    Other: parenteral nutrition
    3000 mL parenteral nutrition fluid, intravenously.
    Other Name: Made by our hospital.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01568853

Locations
China, Jiangsu
Department of Surgery, Jinling Hospital
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Jinling Hospital, China
Investigators
Principal Investigator: Jianan Ren, M.D. Department of Surgery, Jinling Hospital, China
  More Information

No publications provided by Jinling Hospital, China

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jianan Ren, Clinical professor, Principal investigator, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT01568853     History of Changes
Other Study ID Numbers: BK2010-017-1
Study First Received: March 29, 2012
Last Updated: April 5, 2012
Health Authority: United States: Institutional Review Board
China: Food and Drug Administration

Additional relevant MeSH terms:
Abdominal Abscess
Sepsis
Toxemia
Pancreatitis
Appendicitis
Digestive System Fistula
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Intraabdominal Infections
Gastroenteritis
Gastrointestinal Diseases
Cecal Diseases
Intestinal Diseases
Abscess
Suppuration
Fistula
Pathological Conditions, Anatomical
Norepinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics

ClinicalTrials.gov processed this record on September 18, 2014