Discontinuation Order of Vasopressors in Septic Shock

NCT ID: NCT01493102

Last Updated: 2015-01-30

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

TERMINATED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this study is to evaluate the incidence of hypotension based on the discontinuation order of norepinephrine and vasopressin in patients receiving concomitant norepinephrine and vasopressin infusions for the treatment of septic shock.

Detailed Description

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There are little data regarding the discontinuation of vasopressors in patients with septic shock. Therefore, the investigators intend to evaluate the incidence of hypotension based on the discontinuation order of norepinephrine and vasopressin in patients receiving concomitant norepinephrine and vasopressin infusions for the treatment of septic shock.

Conditions

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Vasopressin

Vasopressin will be reduced first (0.01 U/hour)

Group Type ACTIVE_COMPARATOR

Vasopressin

Intervention Type DRUG

Vasopressin will be reduced first (0.01 U/hour)

Norepinephrine

Norepinephrine: Norepinephrine will be reduced first (0.1 microgram/kg/hour)

Group Type ACTIVE_COMPARATOR

Norepinephrine

Intervention Type DRUG

Norepinephrine will be reduced first (0.1 microgram/kg/hour)

Interventions

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Vasopressin

Vasopressin will be reduced first (0.01 U/hour)

Intervention Type DRUG

Norepinephrine

Norepinephrine will be reduced first (0.1 microgram/kg/hour)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients 20 years of age or older
* patients of receiving concomitant therapy with norepinephrine and vasopressin for teh management of septic shock
* patients began to reduce the vasopressor

Exclusion Criteria

* patients who expired or had care withdrawn while receiving norepinephrine and vasopressin
* patients being transferred into the ICU from an outside facility or the operating room
* patients who are suspected to have vasopressin deficiency (eg. HPA axis dysfunction, empty sella)
* acute myocardial infarction or Congestive heart failure (NYHA functional classification III or IV)
* acute mesenteric ischemia
* patients who were received other vasopressor except for norepinephrine or vasopressin
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kyeongman Jeon

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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kyeongman Jeon, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Jeon K, Song JU, Chung CR, Yang JH, Suh GY. Incidence of hypotension according to the discontinuation order of vasopressors in the management of septic shock: a prospective randomized trial (DOVSS). Crit Care. 2018 May 21;22(1):131. doi: 10.1186/s13054-018-2034-9.

Reference Type DERIVED
PMID: 29784057 (View on PubMed)

Other Identifiers

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2011-09-007

Identifier Type: -

Identifier Source: org_study_id

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