- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02266589
Stress Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock
October 16, 2014 updated by: Gao Tao, Nanjing PLA General Hospital
Research of Little Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock
The purpose of this study is to find out whether stress doses of hydrocortisone attenuate coagulation dysfunction in patients with septic shock.
And discuss the probable mechanism by which little doses of hydrocortisone influence coagulation system in sepsis.
Study Overview
Detailed Description
Patients were randomized to receive either low-dose hydrocortisone or matching placebo.Severity of coagulopathy was estimated using ISTH DIC score.
We determined the complications and mortality in two groups, and analyzed the relationship between hydrocortisone and coagulopathy.
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All patients(age≧18y)
- Admitted for septic shock were considered eligible if they had no life-threatening systemic disease (ASA groups 1~3)
Exclusion Criteria:
- Lactation
- Mental disorders
- Disseminated cancer
- Secondary cancers
- Inflammatory bowel disease, or diseases hindering epidural analgesia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Placebo
|
|
Experimental: Hydrocortisone
little doses of hydrocortisone
|
Hydrocortisone hemisuccinate (Roussel-Uclaf, Romainville, France), 50 mg intravenously every 6 hrs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
coagulopathy
Time Frame: 30 days after inclusion
|
ISTH score
|
30 days after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
death
Time Frame: 30 days after inclusion
|
30 days after inclusion
|
|
clinical complications
Time Frame: 30 days after inclusion
|
MODS SOFA score
|
30 days after inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
October 12, 2014
First Submitted That Met QC Criteria
October 16, 2014
First Posted (Estimate)
October 17, 2014
Study Record Updates
Last Update Posted (Estimate)
October 17, 2014
Last Update Submitted That Met QC Criteria
October 16, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011NLY031
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sepsis
-
University of Kansas Medical CenterUniversity of KansasRecruitingSepsis | Septic Shock | Sepsis Syndrome | Sepsis, Severe | Sepsis Bacterial | Sepsis BacteremiaUnited States
-
Jip GroenInBiomeRecruitingMicrobial Colonization | Neonatal Infection | Neonatal Sepsis, Early-Onset | Microbial Disease | Clinical Sepsis | Culture Negative Neonatal Sepsis | Neonatal Sepsis, Late-Onset | Culture Positive Neonatal SepsisNetherlands
-
Karolinska InstitutetÖrebro University, SwedenCompletedSepsis | Sepsis Syndrome | Sepsis, SevereSweden
-
The University of QueenslandRoyal Brisbane and Women's HospitalUnknown
-
Ohio State UniversityCompletedSepsis, Severe Sepsis and Septic ShockUnited States
-
Indonesia UniversityCompletedSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockIndonesia
-
Beckman Coulter, Inc.Biomedical Advanced Research and Development AuthorityRecruitingSevere Sepsis | Severe Sepsis Without Septic ShockUnited States
-
University of LeicesterUniversity Hospitals, Leicester; The Royal College of AnaesthetistsCompletedSepsis | Septic Shock | Severe Sepsis | Sepsis SyndromeUnited Kingdom
-
Zagazig UniversityRecruitingSepsis-associated EncephalopathyEgypt
-
Weill Medical College of Cornell UniversityNational Heart, Lung, and Blood Institute (NHLBI); New York Presbyterian Hospital and other collaboratorsCompletedSepsis | Septic Shock | Severe Sepsis | Infection | Sepsis SyndromeUnited States
Clinical Trials on Hydrocortisone
-
Assistance Publique - Hôpitaux de ParisCompletedBronchopulmonary DysplasiaFrance
-
Horus UniversityRecruitingSubacromial Impingement Syndrome | Impingement SyndromeEgypt
-
University Hospital Southampton NHS Foundation...Imperial College London; University of Bristol; University Hospitals Bristol... and other collaboratorsCompleted
-
Ulla Feldt-RasmussenUnknown
-
University of VersaillesAssistance Publique - Hôpitaux de ParisTerminatedPneumonia, Viral | Influenza in HumansFrance
-
Vastra Gotaland RegionSahlgrenska University Hospital, Sweden; The Gothenburg Society of Medicine; Åke... and other collaboratorsNot yet recruitingDiabetes Mellitus | Adrenal Insufficiency | Polyglandular Autoimmune SyndromeSweden
-
Siriraj HospitalNot yet recruiting
-
Dartmouth-Hitchcock Medical CenterNational Institute of Allergy and Infectious Diseases (NIAID)Completed
-
Cristcot LLCParexelCompleted
-
Eastern Hepatobiliary Surgery HospitalSuspendedSome Studies Shows That the Steroid Can Reduce the Injury of the I/R of the Liver