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Completed

NCT Number: NCT03120637

Evaluating in Cirrhotics With Refractory Vasoplegia the Effect of Methylene Blue

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.

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Key information

Conditions

Septic Shock Cardiovascular Diseases Cirrhosis, Liver Digestive System Diseases Fibrosis Infections Inflammation Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Refractory Shock Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome Vascular Diseases Vasoplegia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Liver Coma ICU, Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (>18 years )
  • Refractory septic shock (Noradrenaline >0.5mcg/kg/mt )

Exclusion criteria

  • Declined consent
  • Pregnancy
  • Less than 18 years old
  • Immunosuppressant patients (e.g. on steroid medication, active anti-cancer chemotherapeutic agent, etc.)
  • Glucose-6-phosphate dehydrogenase deficiency
  • Medication of Serotonin modulator/SSRI
  • Pre-existing Pulmonary Hypertension
  • CKD-Stage IV/V
  • Patients with GI bleed
  • Patients on DNR
  • Patients declared Brain dead

Treatment and study plan

Methylene Blue

Drug

Primary outcomes

  1. Survival in both groups

    Time frame: 2 days

Secondary outcomes

  1. Systemic Vascular Resistance

    Time frame: 6 hours

    Change in SVR

  2. Mean Arterial Pressure

    Time frame: 6 hours

    Improvement in MAP

  3. Decrease of vasopressor dose of 20 percent from time of start of test drug.

    Time frame: 6 hours

    Effect on decreasing vasopressor doses

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

Evaluating in Cirrhotics With Refractory Vasoplegia the Effect of Methylene Blue in Sepsis: A Randomized Controlled Trial

Acronym: CRuMBS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 19, 2017
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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