Methylene Blue for the Prevention of Hypotension During Hemodialysis

Acute Kidney Injury Clinical Trial

— BLUE  

Official title:

Methylene Blue for the Prevention of Hypotension During Hemodialysis: a Randomized Open Label Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05092165
• Other study ID #: BLUE
• Status: Recruiting
• Phase: Phase 2
• Start date: October 21, 2021
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Federal University of São Paulo
• Contact: Carla Pontes, MD
• Phone: +551155764848
• Email: pontes4[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hypotension is a common complication of intermittent renal replacement therapy. Methylene blue, an inhibitor of nitric oxide synthesis, has been suggested to improve hemodynamics during renal replacement therapy in ambulatory patients, but evidence is lacking for critically ill patients.

This trial will assess whether methylene blue can improve hemodynamics and blood pressure for patients with shock requiring renal replacement therapy.

Description:

This is a single-center, randomized, non-blind study, with a intention-to-treat analysis, aiming to evaluate whether the use of methylene blue reduces the incidence of hypotension during hemodialysis, resulting in a reduction in the need for therapeutic modifications during the session, defined as interruption session, reduced fluid losses and increased need for vasopressors. Patients will be randomized using RedCap platform in variable blocks of 4-6, stratified by center in a 1:1 ratio and by previous use of vasopressors, into two groups, intervention and usual treatment. Access to randomization will be available 24 hours, 7 days a week. Patients on intermittent renal replacement therapy will be selected to receive or not methylene blue at a bolus dose of 1 mg/kg, followed by a continuous infusion of 0.1 mg/kg of body weight in a total of 200 ml of solution. saline throughout the dialysis session. The usual care group will not receive any intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: December 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient or legal representative accepted trial enrollment

2. Age above 18 years

3. Chronic or acute kidney injury in need for renal replacement therapy

4. Blood pressure lower than 100 mmHg or in use of any vasopressor

Exclusion Criteria:

1. Pregnancy

2. Death considered imminent in the next 24 hours

3. Patients not on full code status

4. Hypertensive patients where dialysis was indicated to remove fluids

5. Known allergy to methylene blue

6. Known glucose-6-phosphate deficiency

7. Previously enrolled in the trial

8. Acute coronary Syndrome

9. Domiciliary nitrate use

Related Conditions & MeSH terms

• Acute Kidney Injury
• Hypotension
• Shock

Intervention

Drug:
• Methylene Blue
1 mg per kilogram bolus, followed by 0.1 milligram per kilogram during renal replacement therapy

Other:
• Control
Usual care during renal replacement therapy

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Endpoint	Composite endpoint of: Increase in vasopressor dose in at least 15% of initial dose or interruption of dialysis or reduction in ultrafiltration rate	6 hours
Secondary	Hypotension	Mean blood pressure below 65 mmHg for at least 5 minutes during renal replacement therapy	6 hours
Secondary	Maximum vasopressor dose	Maximum vasopressor dose, in micro-grams per kilogram per minute used during de first 24 hours	24 hours
Secondary	Mortality in the intensive care unit	Death in the intensive care unit	60 days
Secondary	Mortality in the hospital	Death during hospital stay	60 days