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

Primary Purpose

Septic Shock, Refractory Shock

Status
Unknown status
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Methylene Blue
Terlipressin
Sponsored by
Ramathibodi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring refractory septic shock, catecholamine resistance septic shock, terlipressin, methylene blue

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ramathibodi hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

A

B

C

Arm Description

standard care septic shock according sepsis bundles

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)

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)

Outcomes

Primary Outcome Measures

mortality rate
time to wean of vasopressor
ICU duration

Secondary Outcome Measures

hemodynamic parameter: Mean arterial pressure (mmHg)
mmHg, A-line monitoring
hemodynamic parameter: lactate (mmol/l)
mmol/l
hemodynamic parameter: urine output (ml)
ml

Full Information

First Posted
December 22, 2016
Last Updated
August 28, 2018
Sponsor
Ramathibodi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03038503
Brief Title
What Should be the Next Vasopressor for Severe Septic Shock? Methylene Blue or Terlipressin
Official Title
What Should be the Next Vasopressor for Severe Septic Shock Patients? Methylene Blue or Terlipressin
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ramathibodi Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Refractory Shock
Keywords
refractory septic shock, catecholamine resistance septic shock, terlipressin, methylene blue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
No Intervention
Arm Description
standard care septic shock according sepsis bundles
Arm Title
B
Arm Type
Experimental
Arm Description
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)
Arm Title
C
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Methylene Blue
Intervention Description
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
Intervention Name(s)
Terlipressin
Intervention Description
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)
Primary Outcome Measure Information:
Title
mortality rate
Time Frame
7 days
Title
time to wean of vasopressor
Time Frame
through complete weaning off vasopressor, an average of 24 hours
Title
ICU duration
Time Frame
through out off indication need ICU care, an average of 7 days
Secondary Outcome Measure Information:
Title
hemodynamic parameter: Mean arterial pressure (mmHg)
Description
mmHg, A-line monitoring
Time Frame
every 30 min after start protocol up to 6 hr then every 1 hr up to 24 hours
Title
hemodynamic parameter: lactate (mmol/l)
Description
mmol/l
Time Frame
every 2 hr until 6 hr then every 4 hr until wean off vasopressor up to 24 hours
Title
hemodynamic parameter: urine output (ml)
Description
ml
Time Frame
every 2 hr until wean off vasopressor up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
munthana sundusadee, MD
Phone
66639010178
Email
opal_janeway@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
viratch tangsujaritvijit, MD
Organizational Affiliation
Mahidol University
Official's Role
Study Chair
Facility Information:
Facility Name
Ramathibodi hospital
City
Bangkok
ZIP/Postal Code
066
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
munthana sundusadee, md
Phone
66639010178
Email
opal_janeway@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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