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

NCT03038503 | Unknown Phase 3

• 1 other identifier: ID 09-59-14
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

refractory septic shock; catecholamine resistance septic shock; terlipressin; methylene blue

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• hemodynamic parameter: Mean arterial pressure (mmHg)

  every 30 min after start protocol up to 6 hr then every 1 hr up to 24 hours

• hemodynamic parameter: lactate (mmol/l)

  every 2 hr until 6 hr then every 4 hr until wean off vasopressor up to 24 hours

• hemodynamic parameter: urine output (ml)

  every 2 hr until wean off vasopressor up to 24 hours

Study Arms (3)

A

NO INTERVENTION

standard care septic shock according sepsis bundles

B

EXPERIMENTAL

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)

Drug: Methylene Blue

C

EXPERIMENTAL

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)

Drug: Terlipressin

Interventions

Methylene Blue 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)

B

Terlipressin 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)

C

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramathibodi Hospital: lead

Study Sites (1)

Ramathibodi hospital

Bangkok, 066, Thailand

RECRUITING

MeSH Terms

Conditions

Shock, Septic; Shock

Interventions

Methylene Blue; Terlipressin

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• viratch tangsujaritvijit, MD

  Mahidol University

  STUDY CHAIR

Central Study Contacts

munthana sundusadee, MD

CONTACT

66639010178; opal_janeway@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: fellowship in department of pulmonary and critical care department

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: January 31, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)