The Effect of Terlipressin on Intesitnal Function in Sept... | NCT02306239

Studies
The Effect of Terlipressin on Intesitnal Function in Septic Shock Patients

NCT02306239

Sponsor

Liu ZiMeng

Status

Unknown status

Last Update Posted

Dec 30, 2014Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Terlipressin
Septic Shock

Interventions

Terlipressin
Norepinephrine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Aug 2015Estimated

Completion Date

Not provided

First Submitted Date

Dec 1, 2014

First Submission Date that Met QC Criteria

Dec 2, 2014

First Posted Date

Dec 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 25, 2014

Last Update Posted Date

Dec 30, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Liu ZiMeng, surgical intensive care unit, First Affiliated Hospital, Sun Yat-Sen UniversitySponsor-Investigator

Lead Sponsor

Liu ZiMengOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
norepinephrine	Active Comparator	patients received norepinephrine	Drug: Norepinephrine
terlipressin	Experimental	patients received terlipressin	Drug: Terlipressin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Terlipressin	Drug		terlipressin
Norepinephrine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intestinal function assessed by abdominal distension, intestinal bleeding, peritonitis, plasma DAO level, enteral nutrition		7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

septic shock

Exclusion Criteria:

shock due to other reasons
diagnosited intesitinal ischemia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
liu zimeng, master	Contact	020-87755766		sumslzm@163.com
zhang xuyu, master	Contact	020-87755766		sumsxyz@163.com

Overall Officials

Name	Affiliation	Role
liu zimeng, master	the first affiliated hospital of SUMS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the First Affiliated Hospital of Sumyetsan University	Recruiting	Guangzhou	Guangdong	510080	China

Condition Browse Module

MeSH Terms

ID	Term
D012772	Shock, Septic

Ancestor Terms

ID	Term
D018805	Sepsis
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077585	Terlipressin
D009638	Norepinephrine

Ancestor Terms

ID	Term
D008236	Lypressin
D014667	Vasopressins
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones

Browse Leaves

Not provided

Browse Branches

Not provided