A Phase 4 interventional study of Methylene Blue in Septic Shock, Vasoplegia and Cirrhosis, Liver, sponsored by Institute of Liver and Biliary Sciences, India. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-30.
Sponsored by Institute of Liver and Biliary Sciences, India · Phase 4, Interventional, and Supportive care
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.
Exclusion Criteria:
Methylene Blue intravenous route, 2 mg/kg Loading Dose over 30 minutes, followed by 0.5 mg/kg/hr for 6 hours
Drug: Methylene Blue
Survival in both groups
Time frame: 2 days
Systemic Vascular Resistance
Change in SVR
Time frame: 6 hours
Mean Arterial Pressure
Improvement in MAP
Time frame: 6 hours
Decrease of vasopressor dose of 20 percent from time of start of test drug.
Effect on decreasing vasopressor doses
Time frame: 6 hours
Plan to share: No
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Institute of Liver and Biliary Sciences, India