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Discontinuation Order of Vasopressors in Septic Shock (DOVSS)

This study has been terminated.
(Futility by interim analysis)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01493102
First Posted: December 15, 2011
Last Update Posted: January 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kyeongman Jeon, Samsung Medical Center
  Purpose
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.

Condition Intervention
Septic Shock Drug: Vasopressin Drug: Norepinephrine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Incidence of Hypotension Based on the Discontinuation Order of Vasopressors in the Management of Septic Shock

Resource links provided by NLM:


Further study details as provided by Kyeongman Jeon, Samsung Medical Center:

Primary Outcome Measures:
  • Incidence of hypotension [ Time Frame: One hour after dose reduction of vasopressors ]
    Hypotension is defined as mean arterial pressure is less than 65mmHg


Secondary Outcome Measures:
  • 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

  • Vasopressor free day [ Time Frame: 28 days after dose reduction of vasopressors ]
  • 28-day mortality [ Time Frame: 28 days ]
    All cause mortality within 28 days after hospitalization

  • ICU mortality [ Time Frame: 3 months ]
    All cause mortlity during ICU admission

  • In-hospital mortality [ Time Frame: 3 months ]
    All cause mortality during hospitalization


Enrollment: 78
Study Start Date: December 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493102


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: kyeongman Jeon, M.D., Ph.D. Samsung Medical Center
  More Information

Responsible Party: Kyeongman Jeon, Assistant professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01493102     History of Changes
Other Study ID Numbers: 2011-09-007
First Submitted: December 12, 2011
First Posted: December 15, 2011
Last Update Posted: January 30, 2015
Last Verified: January 2015

Keywords provided by Kyeongman Jeon, Samsung Medical Center:
septic shock
norepinephrine
vasopressin
hypotension

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Norepinephrine
Vasopressins
Arginine Vasopressin
Vasoconstrictor Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents