Discontinuation Order of Vasopressors in Septic Shock

Not Applicable

Terminated

• Conditions: Septic Shock
• Interventions: Drug: Vasopressin; Drug: Norepinephrine

• Registration Number: NCT01493102
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-14
• Study First Posted: 2011-12-15
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-28
• Last Update Posted: 2015-01-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 78

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• patients who expired or had care withdrawn while receiving norepinephrine and vasopressin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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vasopressin	Vasopressin	Vasopressin will be reduced first (0.01 U/hour)
Norepinephrine	Norepinephrine	Norepinephrine: Norepinephrine will be reduced first (0.1 microgram/kg/hour)

Primary Outcome Measures

Name	Time	Method
Incidence of hypotension	One hour after dose reduction of vasopressors	Hypotension is defined as mean arterial pressure is less than 65mmHg

Secondary Outcome Measures

Name	Time	Method
Time of hypotension	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	28 days after dose reduction of vasopressors
28-day mortality	28 days	All cause mortality within 28 days after hospitalization
ICU mortality	3 months	All cause mortlity during ICU admission
In-hospital mortality	3 months	All cause mortality during hospitalization

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of