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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
261
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
Usual care during renal replacement therapy
Federal University of São Paulo
São Paulo, São Paulo, Brazil
Composite Endpoint
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.
Time frame: 6 hours
Hypotension
Mean blood pressure below 65 mmHg for at least 5 minutes during renal replacement therapy
Time frame: 6 hours
Maximum vasopressor dose
Maximum vasopressor dose, in micro-grams per kilogram per minute used during de first 24 hours
Time frame: 24 hours
Norepinephrine equivalent dose (NEE)
The cumulative norepinephrine equivalent dose (NEE)
Time frame: 24 hours
RRT session fluid balance
The fluid balance of RTT session
Time frame: 24 hours
24-hour fluid balance
The fluid balance on 24-hour after RTT session
Time frame: 24 hours
Mortality in the intensive care unit
Death in the intensive care unit
Time frame: 60 days
Mortality in the hospital
Death during hospital stay
Time frame: 60 days
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