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

NCT ID: NCT03038503

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-12-31

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)

Conditions

Septic Shock; Refractory Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A

standard care septic shock according sepsis bundles

Group Type: NO_INTERVENTION

No interventions assigned to this group

B

after defined refractory shock (adequate fluid resuscitation + add 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)

Group Type: EXPERIMENTAL

Methylene Blue

Intervention Type: DRUG

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)

C

after defined refractory shock (adequate fluid resuscitation + add 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)

Group Type: EXPERIMENTAL

Terlipressin

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ramathibodi Hospital

OTHER

Sponsor Role: lead

Responsible Party

munthana sundusadee

fellowship in department of pulmonary and critical care department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

viratch tangsujaritvijit, MD

Role: STUDY_CHAIR

Mahidol University

Locations

Ramathibodi hospital

Bangkok, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

munthana sundusadee, MD

Role: CONTACT

opal_janeway@hotmail.com

66639010178

Facility Contacts

munthana sundusadee, md

Role: primary

opal_janeway@hotmail.com

66639010178

Other Identifiers

ID 09-59-14

Identifier Type: -

Identifier Source: org_study_id