NCT02306239

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

December 1, 2014

Last Update Submit

December 25, 2014

Conditions

TerlipressinSeptic Shock

Outcome Measures

Primary Outcomes (1)

  • intestinal function assessed by abdominal distension, intestinal bleeding, peritonitis, plasma DAO level, enteral nutrition

    7 days

Study Arms (2)

norepinephrine

ACTIVE COMPARATOR

patients received norepinephrine

Drug: Norepinephrine

terlipressin

EXPERIMENTAL

patients received terlipressin

Drug: Terlipressin

Interventions

TerlipressinDRUG
terlipressin
NorepinephrineDRUG
norepinephrine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • septic shock

You may not qualify if:

  • shock due to other reasons
  • diagnosited intesitinal ischemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Sumyetsan University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Interventions

TerlipressinNorepinephrine

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

LypressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • liu zimeng, master

    the first affiliated hospital of SUMS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

liu zimeng, master

CONTACT

020-87755766sumslzm@163.com

zhang xuyu, master

CONTACT

020-87755766sumsxyz@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
surgical intensive care unit

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 3, 2014

Study Start

December 1, 2014

Primary Completion

August 1, 2015

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations

CN(1)