Methylene Blue in Sepsis: A Randomized Controlled Trial

NCT00486174 | Withdrawn DMC

• 2 other identifiers: EMED-090-07PSI Grant application #2006-36
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate whether the addition of Methylene Blue to the standard treatment of septic shock will reduce vasopressor requirements

Conditions

Sepsis

Keywords

Sepsis; Methylene Blue; Norepinephrine

Outcome Measures

Primary Outcomes (1)

• The primary outcome of interest is to assess the norepinephrine requirements in the methylene blue groups to maintain a mean arterial blood pressure greater or equal to 65 mmHg in comparison to the control group.

  hourly for 96 hours

Secondary Outcomes (5)

• safety of methylene blue

  96 hours

• survival to ICU discharge

  30 days

• survival to hospital discharge

  30 days

• total norepinephrine administered

  96 hours

• number of whole hours norepinephrine free

  hourly for 96 hours

Study Arms (2)

1

ACTIVE COMPARATOR

standard sepsis therapy plus Methylene Blue

Drug: methylene blue

2

NO INTERVENTION

standard sepsis therapy

Interventions

methylene blue DRUG

2.0 mg/kg of Methylene Blue administered every 6 hours (as required) for up to 48 hours.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First presentation of sepsis syndrome: clinical evidence of infection with Systemic Inflammatory Response Syndrome (SIRS)as defined by two or more of:
• Temperature \> 38°C or \< 36°C,
• Heart rate \> 90 beats per minute,
• One or more of respiratory rate \> 20, hyperventilation with PaCO2 \< 32 mm Hg, requiring mechanical ventilation,
• One or more of white blood cells \> 12,000 X 109 /L or white blood cells \< 4000 X 109 /L or immature neutrophils \> 10%.
• Undergoing early goal directed therapy with a mean arterial blood pressure (MAP) \< 65 mmHg despite fluid resuscitation to CVP \> 10mmHg.
• Able to provide informed consent as per our institutional standard.
• To receive first dose of study drug within six hours of first recorded hypotension (MAP \< 65mmHg).

You may not qualify if:

• Age \< 18 years.
• Undergoing palliation.
• Not expected to survive 48 hours.
• Resuscitated from a vital sign absent arrest.
• Ongoing dialysis.
• Anuric or creatinine \> 300 μmol/L.
• Pregnant.
• Patient or family history of glucose-6-phosphate dehydrogenase deficiency.
• Allergic to methylene blue, phenothiazines, thiazide diuretics, or food dyes.
• Patient mass \> 150 kg.
• Demonstrated Pulmonary Hypertension (Mean Pulmonary Artery Pressure \> 25 mmHg by Swan Ganz Catheter or Echo demonstrated Right Ventricular Systolic Pressure \> 40 mmHg).

Sponsors & Collaborators

• Queen's University: lead
• The Physicians' Services Incorporated Foundation: collaborator

MeSH Terms

Conditions

Sepsis

Interventions

Methylene Blue

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Daniel W Howes, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 12, 2007
• First Posted: June 14, 2007
• Study Start: June 1, 2007
• Last Updated: May 29, 2008

Record last verified: 2008-05