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Trial · Interventional

CompletedPhase 2/3Registry data

Methylene Blue in Early Septic Shock

Short name SHOCKEM-Blue

NCTNCT04446871 (opens ClinicalTrials.gov in a new tab)Other idHCG/CEI-0252/17
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
91 participants (actual)
Sponsor
Hospital Civil de Guadalajara · Other
Design
Randomized · Quadruple masking
Countries
1 country

Mexico

Start
17 Mar 2017
Primary completion
10 Dec 2020
Completion
25 Jan 2021
First posted
25 Jun 2020
Last update posted
4 Nov 2022
Conditions
Septic Shock

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019202020212022
  1. Ph 2/3

    SHOCKEM-Blue

    NCT04446871

    17 Mar 2017 to 25 Jan 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • 0.9% sodium chlorideDrug
  • Methylene BlueDrug

Arms2

  • Placebo comparator

    Standard care

    Placebo

  • Experimental

    Methylene blue

    Methylene blue

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Vasopressor requirement

    Time frame · 28 days

    Registry description

    Total time to shock resolution (hours)

Secondary outcomes(3)

  1. Time to lactate normalization

    Time frame · 7 days

    Registry description

    Time in hours until lactate is \<2 mmol/L

  2. Length of stay in intensive care unit

    Time frame · 28 days

    Registry description

    Time in days until ICU discharge

  3. Intensive care unit mortality

    Time frame · 28 days

    Registry description

    Mortality in intensive care unit

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

7 results

Early adjunctive methylene blue in patients with septic shock: a randomized controlled trial.

Ibarra-Estrada et al. 2023Critical care (London, England)cited by 69

PMID 36915146PMC10010212DOI 10.1186/s13054-023-04397-7PUB-36915146

CC BY7 results
Download PDFSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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