Severe SepsisNCT01568853
A Prospective Study of The Complement Depletion in Patients With Severe Abdominal Sepsis
A study testing Norepinephrine, Open abdomen and enteral nutrition in people with Severe Sepsis and Pancreatitis, run by Jinling Hospital, China at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Severe Sepsis, Pancreatitis, Abdominal Abscess
- What is being tested?
- Norepinephrine, Open abdomen and enteral nutrition
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of severe abdominal sepsis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Complement C3 Depletion in Patients With Severe Abdominal Sepsis: Risk Prediction and the Association With Down-regulated Adaptive Immunity
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.
Read the 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.
- Being tested
- Norepinephrine, Open abdomen, enteral nutrition, parenteral nutrition
- Medical subject headings
- Sepsis, Pancreatitis, Abdominal Abscess, Appendicitis, Digestive System Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Intravenously, 10 ug/min, 24 hours
Open abdomenProcedure or surgery
IAH >=20 mmHg, and ACS emerged, such as low urine and decreased FiO2 quickly.
enteral nutritionOther
Also called Peptison (SP; Nutricia, Shanghai, China)
500-1500 kcal/day; Nasogastric tube feeding;
parenteral nutritionOther
Also called Made by our hospital.
3000 mL parenteral nutrition fluid, intravenously.
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Patients died within the first three days of admission would be excluded from this study.
Measured: within the first 28 days after admission to our hosptial
Secondary outcomes (1)
Postoperative complications
wound complications; pulmonary infection; incisional hernia, and bleeding.
Measured: within the first 28 days after admission to our hosptial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startNov 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianan Ren, Jinling Hospital, China
- Investigators
- Jianan Ren, M.D., Principal investigator, Department of Surgery, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568853
- Sponsor's protocol ID
- BK2010-017-1
- Status last verified
- Apr 2012
- First submitted
- 29 Mar 2012
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ren J, Zhao Y, Yuan Y, Han G, Li W, Huang Q, Tong Z, Li J. Complement depletion deteriorates clinical outcomes of severe abdominal sepsis: a conspirator of infection and coagulopathy in crime? PLoS One. 2012;7(10):e47095. doi: 10.1371/journal.pone.0047095. Epub 2012 Oct 16.
PubMed 23091606
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Complement C3 Depletion in Patients With Severe Abdominal Sepsis: Risk Prediction and the Association With Down-regulated Adaptive Immunity
- ClinicalTrials.gov ID
- NCT01568853
- Acronym / sponsor ID
- BK2010-017-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of severe abdominal sepsis
Key exclusion criteria (6 listed)
- Age < 18 or > 60 years
- Pregnancy
- Leucopenia from radiochemical therapy due to malignant tumor
- Any primary diagnosis other than sepsis
- Confirmed immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NorepinephrineIntravenously, 10 ug/min, 24 hours | Drug | – |
| Open abdomenIAH >=20 mmHg, and ACS emerged, such as low urine and decreased FiO2 quickly. | Procedure or surgery | – |
| enteral nutritionAlso: Peptison (SP; Nutricia, Shanghai, China)500-1500 kcal/day; Nasogastric tube feeding; | Other | – |
| parenteral nutritionAlso: Made by our hospital.3000 mL parenteral nutrition fluid, intravenously. | Other | – |
Primary outcome
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.
1 secondary outcome
Postoperative complications
Time frame: within the first 28 days after admission to our hosptial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
- Derived from this study: PubMed 23091606Ren J, Zhao Y, Yuan Y, Han G, Li W, Huang Q, Tong Z, Li J. Complement depletion deteriorates clinical outcomes of severe abdominal sepsis: a conspirator of infection and coagulopathy in crime? PLoS One. 2012;7(10):e47095. doi: 10.1371/journal.pone.0047095. Epub 2012 Oct 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianan Ren, M.D. principal investigator
Department of Surgery, Jinling Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Norepinephrine, Open abdomen and enteral nutrition in people with Severe Sepsis and Pancreatitis, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: within the first 28 days after admission to our hosptial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01568853, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2012.