Sepsis, Disseminated Intravascular Coagulation
Conditions
Keywords
Severe sepsis, Disseminated intravascular coagulation, Unfractionated heparin
Brief summary
The primary objective of this study is to estimate the efficacy of unfractionated heparin(UFH) on ICU mortality in severe sepsis with suspected DIC.The Second objective is to estimate the effect of UFH on 28-day mortality,and the change of the Japanese Association for Acute Medicine(JAAM) score and SOFA score. The third one is to evaluate the safety of UFH in severe sepsis patients with suspected DIC.
Detailed description
During the study, the whole process of data validation and registry procedures will be implemented by the Principal Investigator of the study, and monitored by the Ethics Committee of the First Affiliated Hospital of China Medical University.There are 2 research supervisors(2 ICU doctors) to assess the accuracy, completeness and representativeness of registry data, and to report the study process and research results to Principal Investigator.Investigators have also edited a data dictionary including each variable used by the registry and normal ranges of all detection indexes. The standard operating procedures have been formulated to address the registry and data analysis. The feasibility and significance have been assessed carefully and funded by the Health and Family Planning Commission of Liaoning Province(No.LNCC-B01-2014).The sample size is 600 participants through statistic calculation. The plan for missing data and statistical analysis will be implemented by specialized statisticians of China Medical University.
Interventions
DRUGHeparin Sodium
A bottle solution of Heparin Sodium(2ml:12500IU) is added to 50ml saline and administered i.v. continuously for 24 hours, which last 7 days or until the death or discharge. The same amount of 0.9% saline as the heparin group will be administered in the placebo group.
DRUGSaline
For all the severe sepsis or septic shock patients, normal saline will be administered for fluid resuscitation according to the Guideline of Survival Sepsis Campaign.
Sponsors
West China Hospital
Zhongda Hospital
The First Affiliated Hospital of Dalian Medical University
Shengjing Hospital
The First Hospital of Jilin University
Qilu Hospital of Shandong University
The Second Affiliated Hospital of Kunming Medical University
The First Hospital of Qinhuangdao
The Second Affiliated Hospital of Dalian Medical University
First Affiliated Hospital of Harbin Medical University
Peking University People's Hospital
The People's Hospital of Liaoning Province
Fourth People's Hospital of Shenyang
Beijing Tsinghua Changgeng Hospital
First Affiliated Hospital of Kunming Medical University
The Affiliated Hospital of Qingdao University
Beijing Friendship Hospital
General Hospital of Ningxia Medical University
The First Affiliated Hospital of Nanchang University
China Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of severe sepsis or/and septic shock * suspected DIC:the score of Platelets plus International Normalized Ratio in the JAAM criteria is equal or more than 3 scores
Exclusion criteria
* consent declined * pregnant or breastfeeding * the length during ICU is less than 24 hours * with other types of shock * have bleeding or high risk for bleeding * have an indication for therapeutic anticoagulation * have a known or suspected adverse reaction to UFH including HIT * are currently enrolled in another trial * known or suspected cirrhosis or other severe hepatic diseases * terminal illness with a life expectancy of less than 28 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICU mortality | during ICU stay (up to day 28) | The mortality during ICU stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 28-day all-cause mortality | after 28 days of enrollment of all the cases | The all-cause mortality at day 28 after enrollment |
| the incidence of major bleeding | during ICU stay (up to day 28) | Major bleeding is defined as intracranial bleeding, life-threatening bleeding, or need red blood cell suspension more than 3 units every 24 hours,and last for 2 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in SOFA scores | during the intervention period (up to day 7 after enrollment) | The difference of SOFA scores between day 7 and day 1 upon enrollment |
| Change in JAAM and ISTH scores | during the intervention period (up to day 7 upon enrollment) | The difference of JAAM and ISTH scores between day7 and day1 upon enrollment |
Countries
China
Contacts
Primary ContactXiaochun Ma, M.D.
Backup ContactYini Sun, Ph.D
Outcome results
None listed