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Methylene Blue for the Prevention of Hypotension During Hemodialysis (BLUE)

Primary Purpose

Acute Kidney Injury, Shock

Status
Not yet recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Methylene Blue
Control
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Methylene Blue

Control

Arm Description

Methylene blue will be infused during renal replacement therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hypotension
Mean blood pressure below 65 mmHg for at least 5 minutes during renal replacement therapy
Maximum vasopressor dose
Maximum vasopressor dose, in micro-grams per kilogram per minute used during de first 24 hours
Mortality in the intensive care unit
Death in the intensive care unit
Mortality in the hospital
Death during hospital stay

Full Information

First Posted
October 13, 2021
Last Updated
October 24, 2021
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT05092165
Brief Title
Methylene Blue for the Prevention of Hypotension During Hemodialysis
Acronym
BLUE
Official Title
Methylene Blue for the Prevention of Hypotension During Hemodialysis: a Randomized Open Label Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 25, 2021 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methylene Blue
Arm Type
Active Comparator
Arm Description
Methylene blue will be infused during renal replacement therapy
Arm Title
Control
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Methylene Blue
Intervention Description
1 mg per kilogram bolus, followed by 0.1 milligram per kilogram during renal replacement therapy
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Usual care during renal replacement therapy
Primary Outcome Measure Information:
Title
Composite Endpoint
Description
Composite endpoint of: Increase in vasopressor dose in at least 15% of initial dose or interruption of dialysis or reduction in ultrafiltration rate
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Hypotension
Description
Mean blood pressure below 65 mmHg for at least 5 minutes during renal replacement therapy
Time Frame
6 hours
Title
Maximum vasopressor dose
Description
Maximum vasopressor dose, in micro-grams per kilogram per minute used during de first 24 hours
Time Frame
24 hours
Title
Mortality in the intensive care unit
Description
Death in the intensive care unit
Time Frame
60 days
Title
Mortality in the hospital
Description
Death during hospital stay
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient or legal representative accepted trial enrollment Age above 18 years Chronic or acute kidney injury in need for renal replacement therapy Blood pressure lower than 100 mmHg or in use of any vasopressor Exclusion Criteria: Pregnancy Death considered imminent in the next 24 hours Patients not on full code status Hypertensive patients where dialysis was indicated to remove fluids Known allergy to methylene blue Known glucose-6-phosphate deficiency Previously enrolled in the trial Acute coronary Syndrome Domiciliary nitrate use
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carla Pontes, MD
Phone
+551155764848
Email
pontes4@live.com
First Name & Middle Initial & Last Name or Official Title & Degree
Flavia R Machado, MD, PhD
Phone
+551155764848
Ext
17018
Email
frmachado@unifesp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla Pontes, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Flavia R Machado, MD, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of São Paulo
City
São Paulo
ZIP/Postal Code
04038002
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla Pontes, MD
Email
pontes4@live.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared upon reasonable request
IPD Sharing Time Frame
6 months after trial is published

Learn more about this trial

Methylene Blue for the Prevention of Hypotension During Hemodialysis

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