Terlipressin Administration in Septic Shock Refractory to... | NCT00793559

Studies
Terlipressin Administration in Septic Shock Refractory to Catecholamines

NCT00793559

Sponsor

Assaf-Harofeh Medical Center

Status

Unknown status

Last Update Posted

Nov 19, 2008Estimated

Enrollment

30Estimated

Phase

Phase 2

Conditions

Septic Shock

Interventions

terlipressin
terlipressin

Countries

Israel

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

Nov 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Jul 2009Estimated

Completion Date

Jul 2009Estimated

First Submitted Date

Nov 18, 2008

First Submission Date that Met QC Criteria

Nov 18, 2008

First Posted Date

Nov 19, 2008Estimated

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

Nov 18, 2008

Last Update Posted Date

Nov 19, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

terlipressin is given to refractory septic shock patients who do not respond to noradrenalin in Israel and Europe. It is given by bolus injection. we attempt to investigate weather it is better to give it by continuous drip and avoid abrupt changes in BP and heart function

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
terlipressin bolus	Active Comparator	1 mg of terlipressin received one time only	Drug: terlipressin
terlipressin drip	Experimental		Drug: terlipressin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
terlipressin	Drug	1 mg of terlipressin one time only	terlipressin bolus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CI, SVR,HR,BP, noradrenalin administration,renal function		6 mo

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

septic shock patients receiving above 0.5 mcg/kg NA

Exclusion Criteria:

allergy to terlipressin, CHF, IHD, pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tal Mann, Dr	Contact	97257345789		tal_mb@hotmail.com

Overall Officials

Name	Affiliation	Role
Tal Mann, Dr	Asaf Harofeh	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asaf Harofeh MC		Zrifin		70300	Israel

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

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided