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Trial · Interventional

CompletedPhase 4Registry data

Evaluating in Cirrhotics With Refractory Vasoplegia the Effect of Methylene Blue

Short name CRuMBS

NCTNCT03120637 (opens ClinicalTrials.gov in a new tab)Other idILBS-Septic Shock-01
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
111 participants (actual)
Sponsor
Institute of Liver and Biliary Sciences, India · Other
Design
Randomized · Double masking
Countries
1 country

India

Start
1 Jan 2017
Primary completion
10 Jan 2018
Completion
10 Jan 2018
First posted
19 Apr 2017
Last update posted
30 Jan 2018
Conditions
Septic Shock · Vasoplegia · Cirrhosis, Liver · Refractory Shock

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019
  1. Ph 4

    CRuMBS

    NCT03120637

    1 Jan 2017 to 10 Jan 2018

Registry summary

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

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.

Interventions

  • Methylene BlueDrug

Arms2

  • 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

  • No intervention

    Standard Treatment

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Survival in both groups

    Time frame · 2 days

Secondary outcomes(3)

  1. Systemic Vascular Resistance

    Time frame · 6 hours

    Registry description

    Change in SVR

  2. Mean Arterial Pressure

    Time frame · 6 hours

    Registry description

    Improvement in MAP

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

    Time frame · 6 hours

    Registry description

    Effect on decreasing vasopressor doses

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

Studies4

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2010

13 results

A dose-finding study of methylene blue to inhibit nitric oxide actions in the hemodynamics of human septic shock.

Juffermans et al. 2010Nitric oxide : biology and chemistrycited by 69

PMID 20109575DOI 10.1016/j.niox.2010.01.006PUB-20109575

Full text at the publisher13 results
Publisher pageSee results (13)

Indexing hint: Randomized controlled trial · 2001

16 results

Infusion of methylene blue in human septic shock: a pilot, randomized, controlled study.

Kirov et al. 2001Critical care medicinecited by 173

PMID 11588440DOI 10.1097/00003246-200110000-00002PUB-11588440

Full text at the publisher16 results
Publisher pageSee results (16)

More studies

2 studies on this page

Indexing hint: Review · 2013

Therapeutic strategies for high-dose vasopressor-dependent shock.

Bassi et al. 2013Critical care research and practicecited by 40

PMID 24151551PMC3787628DOI 10.1155/2013/654708PUB-24151551

CC BY
Download PDF

Indexing hint: Observational study · 2005

The effects of methylene blue on hemodynamic parameters and cytokine levels in refractory septic shock.

Park et al. 2005The Korean journal of internal medicinecited by 37

PMID 16134766PMC3891380DOI 10.3904/kjim.2005.20.2.123PUB-16134766

Free to read · publisher termsCC BY-NC
Read at source

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultMemis D, Karamanlioglu B, Yuksel M, Gemlik I, Pamukcu Z. The influence of methylene blue infusion on cytokine levels during severe sepsis. Anaesth Intensive Care. 2002 Dec;30(6):755-62. doi: 10.1177/0310057X0203000606. PMID 12500513

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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