- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02306239
The Effect of Terlipressin on Intesitnal Function in Septic Shock Patients
December 25, 2014 updated by: Liu ZiMeng
the Surgical Intensive Care Unit
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Recruiting
- the First Affiliated Hospital of Sumyetsan University
-
Contact:
- liu zimeng, doctor
- Phone Number: 87755766 020
- Email: sumslzm@163.com
-
Contact:
- zhang xuyu, doctor
- Phone Number: 87755766 020
- Email: sumsxyz@163.com
-
-
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:
- septic shock
Exclusion Criteria:
- shock due to other reasons
- diagnosited intesitinal ischemia
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: norepinephrine
patients received norepinephrine
|
|
|
Experimental: terlipressin
patients received terlipressin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
intestinal function assessed by abdominal distension, intestinal bleeding, peritonitis, plasma DAO level, enteral nutrition
Time Frame: 7 days
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: liu zimeng, master, the first affiliated hospital of SUMS
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
December 1, 2014
Primary Completion (Anticipated)
August 1, 2015
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
December 1, 2014
First Submitted That Met QC Criteria
December 2, 2014
First Posted (Estimate)
December 3, 2014
Study Record Updates
Last Update Posted (Estimate)
December 30, 2014
Last Update Submitted That Met QC Criteria
December 25, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Shock
- Sepsis
- Shock, Septic
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Norepinephrine
- Terlipressin
Other Study ID Numbers
- 2012A080204018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
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-
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-
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