Refractory Shock, Septic Shock
Conditions
Keywords
refractory septic shock, catecholamine resistance septic shock, terlipressin, methylene blue
Brief summary
The ICU mortality rate of patients with septic shock was still high upto 54.1%.In first 6 hours of resuscitation, the goals of resuscitation in sepsis shock after adequate fluid resuscitation is MAP ≥65 mmHg. In refractory septic shock patient, prolong shock correlate with poor outcome due to multiple organ failure. Alternative vasopressor in septic shock with catecholamine resistance has been studied such as terlipressin, methylene blue * Terlipressin (TP) mediate vasoconstriction via V1 receptors coupled to phospholipase C, and increases intracellular Ca2+ concentration * Methylene blue (MB) directly inhibits nitric oxide synthase (NOS) by inhibit the enzyme guanylate cyclase (GC)
Interventions
DRUGMethylene Blue
after defined refractory shock (need NE\>0.5 mcg/kg/min) add Methylene blue 1 mg/kg iv drip then 2 hr later drip 0.5 mg/kg/hr\*4 hr (intervention add on to standard care)
DRUGTerlipressin
after defined refractory shock (need NE\>0.5 mcg/kg/min) add terlipressin 1 mg IV then repeated dose 20 min later if unstable BP (intervention add on to standard care)
Sponsors
Ramathibodi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>15 years old * Diagnosis septic shock as SCCM/ACCP * Refractory septic shock defined as hypotension although adequate fluid resuscitate and high dose vasopressor(NE \>0.5 mcg/kg/min) * Concent form
Exclusion criteria
* Known case G6PD deficiency * Acute respiratory distress syndrome (ARDS) * Hx of drug allergy MB, NE, terlipressin * Hx of Raynaud's phenomenon, systemic sclerosis, PHT * Known case coronary heart disease without treatment * Current drug use serotonin reuptake inhibitors (SSRI), Serotonin and norepinephrine reuptake inhibitors (SNRIs) * Reject to join project
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mortality rate | 7 days |
| time to wean of vasopressor | through complete weaning off vasopressor, an average of 24 hours |
| ICU duration | through out off indication need ICU care, an average of 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hemodynamic parameter: Mean arterial pressure (mmHg) | every 30 min after start protocol up to 6 hr then every 1 hr up to 24 hours | mmHg, A-line monitoring |
| hemodynamic parameter: lactate (mmol/l) | every 2 hr until 6 hr then every 4 hr until wean off vasopressor up to 24 hours | mmol/l |
| hemodynamic parameter: urine output (ml) | every 2 hr until wean off vasopressor up to 24 hours | ml |
Countries
Thailand
Contacts
Primary Contactmunthana sundusadee, MD
Outcome results
None listed