Septic Shock
Conditions
Keywords
septic shock, norepinephrine, vasopressin, hypotension
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.
Interventions
DRUGVasopressin
Vasopressin will be reduced first (0.01 U/hour)
DRUGNorepinephrine
Norepinephrine will be reduced first (0.1 microgram/kg/hour)
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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* patients who expired or had care withdrawn while receiving norepinephrine and vasopressin * patients being transferred into the ICU from an outside facility or the operating room * patients who are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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypotension | One hour after dose reduction of vasopressors | Hypotension is defined as mean arterial pressure is less than 65mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed