Discontinuation Order of Vasopressors in Septic Shock

Septic Shock Clinical Trial

— DOVSS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01493102
• Other study ID #: 2011-09-007
• Status: Terminated
• Phase: N/A
• First received: December 12, 2011
• Last updated: January 28, 2015
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2015
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 78
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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• patients who expired or had care withdrawn while receiving norepinephrine and vasopressin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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Vasopressin
Vasopressin will be reduced first (0.01 U/hour)
• Norepinephrine
Norepinephrine will be reduced first (0.1 microgram/kg/hour)

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypotension	Hypotension is defined as mean arterial pressure is less than 65mmHg	One hour after dose reduction of vasopressors	Yes
Secondary	Time of hypotension	Time interval (min) from time of dose reduction of vasopressors to time to development of hypotension	One hour after dose reduction of vasopressors	No
Secondary	Vasopressor free day		28 days after dose reduction of vasopressors	No
Secondary	28-day mortality	All cause mortality within 28 days after hospitalization	28 days	No
Secondary	ICU mortality	All cause mortlity during ICU admission	3 months	No
Secondary	In-hospital mortality	All cause mortality during hospitalization	3 months	No