Discontinuation Order of Vasopressors in Septic Shock (DOVSS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Kyeongman Jeon, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01493102
First received: December 12, 2011
Last updated: December 14, 2011
Last verified: December 2011
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Samsung Medical Center:

Primary Outcome Measures:
  • Incidence of hypotension [ Time Frame: One hour after dose reduction of vasopressors ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 28-day mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    All cause mortality within 28 days after hospitalization

  • ICU mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    All cause mortlity during ICU admission

  • In-hospital mortality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    All cause mortality during hospitalization


Estimated Enrollment: 134
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493102

Contacts
Contact: Kyeongman Jeon, M.D., Ph.D. 82-3410-3429 kjeon@skku.edu

Locations
Korea, Republic of
Samsung Medical Center Recruiting
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

No publications provided

Responsible Party: Kyeongman Jeon, Assistant professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01493102     History of Changes
Other Study ID Numbers: 2011-09-007
Study First Received: December 12, 2011
Last Updated: December 14, 2011
Health Authority: Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Shock
Shock, Septic
Hypotension
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Vasopressins
Arginine Vasopressin
Norepinephrine
Vasoconstrictor Agents
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 24, 2014