BLUE: Methylene Blue for the Prevention of Hypotension During Hemodialysis

• Sponsor: Federal University of São Paulo (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05092165
• Collaborator: (none)
• Enrollment: 260
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 49.2
• Patients Per Site Per Month: 5.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury; Shock	Drug: Methylene Blue; Other: Control	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Methylene Blue for the Prevention of Hypotension During Hemodialysis: a Randomized Open Label Trial
• Anticipated Study Start Date: Oct 25, 2021
• Anticipated Primary Completion Date: Oct 1, 2024
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Methylene Blue Methylene blue will be infused during renal replacement therapy	Drug: Methylene Blue; 1 mg per kilogram bolus, followed by 0.1 milligram per kilogram during renal replacement therapy
Other: Control	Other: Control; Usual care during renal replacement therapy

Outcome Measures

Primary Outcome Measures

1. Composite Endpoint [6 hours]

   Composite endpoint of: Increase in vasopressor dose in at least 15% of initial dose or interruption of dialysis or reduction in ultrafiltration rate

Secondary Outcome Measures

1. Hypotension [6 hours]

   Mean blood pressure below 65 mmHg for at least 5 minutes during renal replacement therapy

2. Maximum vasopressor dose [24 hours]

   Maximum vasopressor dose, in micro-grams per kilogram per minute used during de first 24 hours

3. Mortality in the intensive care unit [60 days]

   Death in the intensive care unit

4. Mortality in the hospital [60 days]

   Death during hospital stay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Federal University of São Paulo	São Paulo		Brazil	04038002

Sponsors and Collaborators

• Federal University of São Paulo

Investigators

• Principal Investigator: Carla Pontes, MD, Federal University of São Paulo
• Study Chair: Flavia R Machado, MD, PhD, Federal University of São Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Flavia Ribeiro Machado, Chief of Critical Care Department, Federal University of São Paulo
• ClinicalTrials.gov Identifier: NCT05092165
• Other Study ID Numbers: BLUE
• First Posted: Oct 25, 2021
• Last Update Posted: Oct 29, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acute Kidney Injury; Hypotension; Methylene Blue

Study Results

No Results Posted as of Oct 29, 2021