Discontinuation Order of Vasopressors in Septic Shock (DOVSS)

January 28, 2015 updated by: Kyeongman Jeon, Samsung Medical Center

Incidence of Hypotension Based on the Discontinuation Order of Vasopressors in the Management of Septic Shock

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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  • patients who expired or had care withdrawn while receiving norepinephrine and vasopressin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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vasopressin
Vasopressin will be reduced first (0.01 U/hour)
Drug: Vasopressin
Vasopressin will be reduced first (0.01 U/hour)
Active Comparator: Norepinephrine
Norepinephrine: Norepinephrine will be reduced first (0.1 microgram/kg/hour)
Drug: Norepinephrine
Norepinephrine will be reduced first (0.1 microgram/kg/hour)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of hypotension
Time Frame: One hour after dose reduction of vasopressors
Hypotension is defined as mean arterial pressure is less than 65mmHg
One hour after dose reduction of vasopressors

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of hypotension
Time Frame: One hour after dose reduction of vasopressors
Time interval (min) from time of dose reduction of vasopressors to time to development of hypotension
One hour after dose reduction of vasopressors
Vasopressor free day
Time Frame: 28 days after dose reduction of vasopressors
28 days after dose reduction of vasopressors
28-day mortality
Time Frame: 28 days
All cause mortality within 28 days after hospitalization
28 days
ICU mortality
Time Frame: 3 months
All cause mortlity during ICU admission
3 months
In-hospital mortality
Time Frame: 3 months
All cause mortality during hospitalization
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: kyeongman Jeon, M.D., Ph.D., Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 12, 2011

First Submitted That Met QC Criteria

December 14, 2011

First Posted (Estimate)

December 15, 2011

Study Record Updates

Last Update Posted (Estimate)

January 30, 2015

Last Update Submitted That Met QC Criteria

January 28, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-09-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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