The Effect of Terlipressin on Intesitnal Function in Septic Shock Patients
Primary Purpose
Terlipressin, Septic Shock
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Terlipressin
Norepinephrine
Sponsored by
About this trial
This is an interventional treatment trial for Terlipressin
Eligibility Criteria
Inclusion Criteria:
- septic shock
Exclusion Criteria:
- shock due to other reasons
- diagnosited intesitinal ischemia
Sites / Locations
- the First Affiliated Hospital of Sumyetsan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
norepinephrine
terlipressin
Arm Description
patients received norepinephrine
patients received terlipressin
Outcomes
Primary Outcome Measures
intestinal function assessed by abdominal distension, intestinal bleeding, peritonitis, plasma DAO level, enteral nutrition
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02306239
Brief Title
The Effect of Terlipressin on Intesitnal Function in Septic Shock Patients
Official Title
the Surgical Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Liu ZiMeng
4. Oversight
5. Study Description
Brief Summary
Terlipressin becomes a vasopressin for septic shock. But some studies found it may lead to severe intesitnal complications such as intestinal ischemia. The investigators study was designed to find the effect of terlipressin on intestinal function in septic shock patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Terlipressin, Septic Shock
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
norepinephrine
Arm Type
Active Comparator
Arm Description
patients received norepinephrine
Arm Title
terlipressin
Arm Type
Experimental
Arm Description
patients received terlipressin
Intervention Type
Drug
Intervention Name(s)
Terlipressin
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Primary Outcome Measure Information:
Title
intestinal function assessed by abdominal distension, intestinal bleeding, peritonitis, plasma DAO level, enteral nutrition
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
septic shock
Exclusion Criteria:
shock due to other reasons
diagnosited intesitinal ischemia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
liu zimeng, master
Phone
020-87755766
Email
sumslzm@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
zhang xuyu, master
Phone
020-87755766
Email
sumsxyz@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
liu zimeng, master
Organizational Affiliation
the first affiliated hospital of SUMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
the First Affiliated Hospital of Sumyetsan University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
liu zimeng, doctor
Phone
020
Ext
87755766
Email
sumslzm@163.com
First Name & Middle Initial & Last Name & Degree
zhang xuyu, doctor
Phone
020
Ext
87755766
Email
sumsxyz@163.com
12. IPD Sharing Statement
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The Effect of Terlipressin on Intesitnal Function in Septic Shock Patients
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