Discontinuation Order of Vasopressors in Septic Shock

Study Overview
=================
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.

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

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Drug: Vasopressin
* Drug: Norepinephrine


Participation Criteria
=================
Eligibility 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of septic shock patients began to reduce the vasopressor Exclusion Criteria: patients who expired or had care withdrawn while receiving norepinephrine and vasopressin patients being transferred into the ICU from an outside facility or the operating room patients who are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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vasopressin<br>Vasopressin will be reduced first (0.01 U/hour) | Drug: Vasopressin<br>* Vasopressin will be reduced first (0.01 U/hour)<br>|
| Active Comparator: Norepinephrine<br>Norepinephrine: Norepinephrine will be reduced first (0.1 microgram/kg/hour) | Drug: Norepinephrine<br>* Norepinephrine will be reduced first (0.1 microgram/kg/hour)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypotension | Hypotension is defined as mean arterial pressure is less than 65mmHg | One hour after dose reduction of vasopressors | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Vasopressor free day |  | 28 days after dose reduction of vasopressors | 
| 28-day mortality | All cause mortality within 28 days after hospitalization | 28 days | 
| ICU mortality | All cause mortlity during ICU admission | 3 months | 
| In-hospital mortality | All cause mortality during hospitalization | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
septic shock, norepinephrine, vasopressin, hypotension