NCT04446871

Brief Summary

Septic shock is a subset of sepsis characterized by a decrease in vascular tone, which contributes to impaired regional blood flow distribution, and leads to organic failure. Besides intravenous fluids and adequate antimicrobial therapy, patients with septic shock require vasopressor support, which can lead to many adverse effects, therefore, non-vasopressor agents that can improve hemodynamic status are needed. In this randomized controlled-study, the investigators will address the efficacy and safety of infusion with methylene blue in patients with septic shock.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2017

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2017

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2021

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

3.7 years

First QC Date

June 22, 2020

Last Update Submit

November 2, 2022

Conditions

Septic Shock

Keywords

Septic shockMethylene blueNorepinephrine

Outcome Measures

Primary Outcomes (1)

  • Vasopressor requirement

    Total time to shock resolution (hours)

    28 days

Secondary Outcomes (3)

  • Time to lactate normalization

    7 days

  • Length of stay in intensive care unit

    28 days

  • Intensive care unit mortality

    28 days

Other Outcomes (1)

  • Change in pulmonary function after treatment

    7 days

Study Arms (2)

Standard care

PLACEBO COMPARATOR

Placebo

Drug: 0.9% sodium chloride

Methylene blue

EXPERIMENTAL

Methylene blue

Drug: Methylene Blue

Interventions

0.9% sodium chlorideDRUG

Intravenous infusion of 500 cc of 0.9% sodium chloride solution for 6 h, once a day for a total of 3 doses.

Standard care
Methylene BlueDRUG

Intravenous infusion of 100 mg methylene blue in 500 cc of 0.9% sodium chloride solution for 6 h, once a day for a total of 3 doses.

Methylene blue

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Septic shock diagnosis, according to the Sepsis-3 consensus.
  • Prior adequate fluid resuscitation according to dynamic predictors of volume responsiveness.
  • More than 6 h and less than 24 h of norepinephrine requirement to maintain a mean arterial pressure ≥65 mmHg.

You may not qualify if:

  • Age \< 18 years.
  • Pregnancy.
  • Not expected to survive 48 hours.
  • Presence or high suspicion of concurrent hemorrhagic, obstructive or hypovolemic shock.
  • Personal or familiar history of glucose-6-phosphate dehydrogenase deficiency.
  • Allergic to methylene blue, phenothiazines, or food dyes.
  • Recent intake (4-weeks) of selective serotonin re-uptake inhibitors.
  • Refusal of the patient or decision maker to enroll in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Civil Fray Antonio Alcalde

Guadalajara, 44280, Mexico

Location

Related Publications (1)

  • Ibarra-Estrada M, Kattan E, Aguilera-Gonzalez P, Sandoval-Plascencia L, Rico-Jauregui U, Gomez-Partida CA, Ortiz-Macias IX, Lopez-Pulgarin JA, Chavez-Pena Q, Mijangos-Mendez JC, Aguirre-Avalos G, Hernandez G. Early adjunctive methylene blue in patients with septic shock: a randomized controlled trial. Crit Care. 2023 Mar 13;27(1):110. doi: 10.1186/s13054-023-04397-7.

    PMID: 36915146DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

Sodium ChlorideMethylene Blue

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsPhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Miguel Ibarra-Estrada, MD

    Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 22, 2020

First Posted

June 25, 2020

Study Start

March 17, 2017

Primary Completion

December 10, 2020

Study Completion

January 25, 2021

Last Updated

November 4, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)