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Evaluating in Cirrhotics With Refractory Vasoplegia the Effect of Methylene Blue (CRuMBS)

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ClinicalTrials.gov Identifier: NCT03120637
Recruitment Status : Completed
First Posted : April 19, 2017
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Brief 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.

Condition or disease Intervention/treatment Phase
Septic Shock Vasoplegia Cirrhosis, Liver Refractory Shock Drug: Methylene Blue Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluating in Cirrhotics With Refractory Vasoplegia the Effect of Methylene Blue in Sepsis: A Randomized Controlled Trial
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : January 10, 2018
Actual Study Completion Date : January 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Methylene Blue
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
No Intervention: Standard Treatment



Primary Outcome Measures :
  1. Survival in both groups [ Time Frame: 2 days ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120637


Locations
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India
Liver Coma ICU, Institute of Liver and Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
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Principal Investigator: Karthik Ponnappan, MD Institute of Liver and Biliary Sciences

Publications of Results:
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03120637     History of Changes
Other Study ID Numbers: ILBS-Septic Shock-01
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institute of Liver and Biliary Sciences, India:
Methylene Blue
Septic Shock
Vasoplegia
Cirrhosis

Additional relevant MeSH terms:
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Shock
Fibrosis
Shock, Septic
Liver Cirrhosis
Vasoplegia
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Liver Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action