Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Discontinuation Order of Vasopressors in Septic Shock (DOVSS)

This study has been terminated.
(Futility by interim analysis)
Sponsor:
Information provided by (Responsible Party):
Kyeongman Jeon, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01493102
First received: December 12, 2011
Last updated: January 28, 2015
Last verified: January 2015

December 12, 2011
January 28, 2015
December 2011
December 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01493102 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Discontinuation Order of Vasopressors in Septic Shock
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Septic Shock
  • Drug: Vasopressin
    Vasopressin will be reduced first (0.01 U/hour)
  • Drug: Norepinephrine
    Norepinephrine will be reduced first (0.1 microgram/kg/hour)
  • Active Comparator: Vasopressin
    Vasopressin will be reduced first (0.01 U/hour)
    Intervention: Drug: Vasopressin
  • Active Comparator: Norepinephrine
    Norepinephrine: Norepinephrine will be reduced first (0.1 microgram/kg/hour)
    Intervention: Drug: Norepinephrine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
78
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01493102
2011-09-007
No
Kyeongman Jeon, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: kyeongman Jeon, M.D., Ph.D. Samsung Medical Center
Samsung Medical Center
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP