What Should be the Next Vasopressor for Severe Septic Shock? Methylene Blue or Terlipressin

Septic Shock Clinical Trial

Official title:

What Should be the Next Vasopressor for Severe Septic Shock Patients? Methylene Blue or Terlipressin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03038503
• Other study ID #: ID 09-59-14
• Status: Recruiting
• Phase: Phase 3
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2018
• Source: Ramathibodi Hospital
• Contact: munthana sundusadee, MD
• Phone: 66639010178
• Email: opal_janeway[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Refractory Shock
• Septic Shock
• Shock
• Shock, Septic

Intervention

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)
• 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)

Locations

Country	Name	City	State
Thailand	Ramathibodi hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality rate		7 days
Primary	time to wean of vasopressor		through complete weaning off vasopressor, an average of 24 hours
Primary	ICU duration		through out off indication need ICU care, an average of 7 days
Secondary	hemodynamic parameter: Mean arterial pressure (mmHg)	mmHg, A-line monitoring	every 30 min after start protocol up to 6 hr then every 1 hr up to 24 hours
Secondary	hemodynamic parameter: lactate (mmol/l)	mmol/l	every 2 hr until 6 hr then every 4 hr until wean off vasopressor up to 24 hours
Secondary	hemodynamic parameter: urine output (ml)	ml	every 2 hr until wean off vasopressor up to 24 hours