DRUG
Methylene 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)
What Should be the Next Vasopressor for Severe Septic Shock? Methylene Blue or Terlipressin
Status
Unknown
Phase
Phase 3
Enrollment
60
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Treatment arms and agents.
DRUG
Terlipressin
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)
Timeline
From registration to results.
First posted
Jan 31, 2017
Study start
Dec 2016
Primary completion
Dec 2018
Study completion
Dec 2018
Results posted
Not reported
Registry updated
Aug 29, 2018
Outcomes
What the study measures.
Primary outcomes
mortality rate
Time frame · 7 days
time to wean of vasopressor
Time frame · through complete weaning off vasopressor, an average of 24 hours
ICU duration
Time frame · through out off indication need ICU care, an average of 7 days
Secondary outcomes
hemodynamic parameter: Mean arterial pressure (mmHg)
Time frame · 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)
Time frame · 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)
Time frame · every 2 hr until wean off vasopressor up to 24 hours
ml
Eligibility
Who can take part.
- Minimum age
- 15 Years
- Maximum age
- Not reported
- Sex
- ALL
- 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
Study locations
1 registered sites.
Thailand. Showing up to 24 locations stored in the fast local snapshot.
Ramathibodi hospital
Bangkok, Thailand
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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