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Evaluating in Cirrhotics With Refractory Vasoplegia the Effect of Methylene Blue

NCT03120637 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2018-01-30

No results posted yet for this study

Summary

Mortality rates associated septic shock remains unacceptably high, around 20-50%, with refractory hypotension in half of these patients. Widespread vasodilatation involves the activation of the soluble intracellular enzyme guanylate cyclase (GC) by nitric oxide (NO), resulting in the production of cyclic guanosine monophosphate (cGMP). Initially discovered as an endothelium-derived relaxing factor in blood vessels, NO is made by the enzyme nitric oxide synthase (NOS). It has been suggested that the inhibition of NO generation might be a treatment option for sepsis and septic shock. Methylene blue (MB) is a dye that easily crosses cell membranes, inhibits iNOS, and is capable of inhibiting the GC enzyme in vascular smooth muscle cells.Early use of MB can block the progressive decrease in systemic vascular resistance of patients unresponsive to noradrenaline and mitigate the need for prolonged vasoconstrictor use. The investigators propose to study the effect of methylene blue on cirrhotic adults with sepsis, with refractory vasoplegia unresponsive to maximum doses of noradrenaline and vasopressin.

Conditions

  • Septic Shock
  • Vasoplegia
  • Cirrhosis, Liver
  • Refractory Shock

Interventions

DRUG

Methylene Blue

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Principal Investigators

  • Karthik Ponnappan, MD · Institute of Liver and Biliary Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2018-01-10
Completion
2018-01-10

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03120637 on ClinicalTrials.gov