Acute Kidney Injury, Intradialytic Hypertension in Hemodialysis Patients, Intradialytic Hypotension, Shock
Conditions
Keywords
methylene blue, intradialytic hypotension, hemodialysis
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.
Detailed description
BLUE is a randomized, multicenter, open-label trial. Patients with high risk of hypotension during RRT will be randomized to receive either methylene blue infusion at a dose of 1 mg/kg as a bolus, followed by continuous infusion of 0.1 mg/kg of body weight in a total of 200 mL of saline solution throughout the dialysis session, or to usual care. The usual care group will not receive any intervention. A total of 260 patients are expected to be randomized in a 1:1 ratio.
Interventions
DRUGMethylene Blue
BLUE group will receive an intravenous infusion of methylene blue. Following a previous study(12), 1 mg/kg of methylene blue 2% diluted in 50 mL of saline solution will be administered as a bolus over 5 minutes, followed by a continuous infusion of 0.1 mg/kg body weight in a total of 250 mL of saline solution throughout the RRT session
OTHERControl
Usual care during renal replacement therapy
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Blinding of healthcare professionals is not feasible due to the distinct visual of methylene blue. However, outcome assessors and statisticians will remain blinded to group allocation to minimize bias.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years old * Acute kidney injury or acute-on-chronic kidney disease requiring intermittent renal replacement therapy hemodialysis * Systolic blood pressure lower than 100 mmHg or use of vasopressor * Signed informed consent
Exclusion criteria
* Pregnancy * Life expectancy less than 24 hours * Exclusive palliative or end-of-life care * RRT due to hypertensive crisis * Known allergy to methylene blue * Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency * Prior participation in the study * Acute coronary syndrome * Chronic nitrate oral use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Endpoint | 6 hours | The primary outcome will be a composite consisting of any of the following events: (1) initiation of vasopressor therapy or an increase in vasopressor dose by at least 20% from baseline; (2) interruption of the RRT session; (3) interruption of fluid removal at the request of the attending physician at any point during the session. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypotension | 6 hours | Mean blood pressure below 65 mmHg for at least 5 minutes during renal replacement therapy |
| Maximum vasopressor dose | 24 hours | Maximum vasopressor dose, in micro-grams per kilogram per minute used during de first 24 hours |
| Norepinephrine equivalent dose (NEE) | 24 hours | The cumulative norepinephrine equivalent dose (NEE) |
| RRT session fluid balance | 24 hours | The fluid balance of RTT session |
| 24-hour fluid balance | 24 hours | The fluid balance on 24-hour after RTT session |
| Mortality in the intensive care unit | 60 days | Death in the intensive care unit |
| Mortality in the hospital | 60 days | Death during hospital stay |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORCarla Pontes, MD
Federal University of São Paulo
STUDY_CHAIRFlavia R Machado, MD, PhD
Federal University of São Paulo
Outcome results
None listed