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Terlipressin Administration in Septic Shock Refractory to Catecholamines

NCT ID: NCT00793559

Last Updated: 2008-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-07-31

Brief Summary

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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

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Conditions

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Septic Shock

Keywords

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septic shock refractory to catecholamines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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terlipressin bolus

1 mg of terlipressin received one time only

Group Type ACTIVE_COMPARATOR

terlipressin

Intervention Type DRUG

1 mg of terlipressin one time only

terlipressin drip

Group Type EXPERIMENTAL

terlipressin

Intervention Type DRUG

1 mg of terlipressin in 50 cc of NS given at a drip of a total of 6 h

Interventions

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terlipressin

1 mg of terlipressin one time only

Intervention Type DRUG

terlipressin

1 mg of terlipressin in 50 cc of NS given at a drip of a total of 6 h

Intervention Type DRUG

Other Intervention Names

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glypressin

Eligibility Criteria

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Inclusion Criteria

* septic shock patients receiving above 0.5 mcg/kg NA

Exclusion Criteria

* allergy to terlipressin, CHF, IHD, pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Assaf-Harofeh Medical Center

Principal Investigators

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Tal Mann, Dr

Role: STUDY_DIRECTOR

Asaf Harofeh

Locations

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Asaf Harofeh MC

Zrifin, , Israel

Site Status

Countries

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Israel

Central Contacts

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Tal Mann, Dr

Role: CONTACT

Phone: 97257345789

Email: [email protected]

Other Identifiers

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161/08

Identifier Type: -

Identifier Source: org_study_id