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Discontinuation Order of Vasopressors in Septic Shock (DOVSS)

Primary Purpose

Septic Shock

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vasopressin
Norepinephrine
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Septic Shock focused on measuring septic shock, norepinephrine, vasopressin, hypotension

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • patients who expired or had care withdrawn while receiving norepinephrine and vasopressin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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Vasopressin

Norepinephrine

Arm Description

Vasopressin will be reduced first (0.01 U/hour)

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

Outcomes

Primary Outcome Measures

Incidence of hypotension
Hypotension is defined as mean arterial pressure is less than 65mmHg

Secondary Outcome Measures

Time of hypotension
Time interval (min) from time of dose reduction of vasopressors to time to development of hypotension
Vasopressor free day
28-day mortality
All cause mortality within 28 days after hospitalization
ICU mortality
All cause mortlity during ICU admission
In-hospital mortality
All cause mortality during hospitalization

Full Information

First Posted
December 12, 2011
Last Updated
January 28, 2015
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01493102
Brief Title
Discontinuation Order of Vasopressors in Septic Shock
Acronym
DOVSS
Official Title
Incidence of Hypotension Based on the Discontinuation Order of Vasopressors in the Management of Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Why Stopped
Futility by interim analysis
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
septic shock, norepinephrine, vasopressin, hypotension

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vasopressin
Arm Type
Active Comparator
Arm Description
Vasopressin will be reduced first (0.01 U/hour)
Arm Title
Norepinephrine
Arm Type
Active Comparator
Arm Description
Norepinephrine: Norepinephrine will be reduced first (0.1 microgram/kg/hour)
Intervention Type
Drug
Intervention Name(s)
Vasopressin
Intervention Description
Vasopressin will be reduced first (0.01 U/hour)
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
Norepinephrine will be reduced first (0.1 microgram/kg/hour)
Primary Outcome Measure Information:
Title
Incidence of hypotension
Description
Hypotension is defined as mean arterial pressure is less than 65mmHg
Time Frame
One hour after dose reduction of vasopressors
Secondary Outcome Measure Information:
Title
Time of hypotension
Description
Time interval (min) from time of dose reduction of vasopressors to time to development of hypotension
Time Frame
One hour after dose reduction of vasopressors
Title
Vasopressor free day
Time Frame
28 days after dose reduction of vasopressors
Title
28-day mortality
Description
All cause mortality within 28 days after hospitalization
Time Frame
28 days
Title
ICU mortality
Description
All cause mortlity during ICU admission
Time Frame
3 months
Title
In-hospital mortality
Description
All cause mortality during hospitalization
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kyeongman Jeon, M.D., Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
29784057
Citation
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.
Results Reference
derived

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Discontinuation Order of Vasopressors in Septic Shock

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