This study aims to analyze the impact of using polysulfone membranes on continuous ultrafiltration with volume replacement in patients undergoing cardiac surgery. In this type of surgery, techniques such as conventional ultrafiltration (CUF) and modified ultrafiltration (MUF) are known for controlling the patient's fluid balance during the procedure. However, there is no scientific evidence on the benefits of continuous haemofiltration with volume replacement and its effect on lactatemia. Method and design: A single center randomized controlled trial, parallel treatment design with patient-blinded to compare outcomes in terms of the lactate clearance rates (quantity/unit of time) of the assigned therapy groups. Participants will be randomly assigned to receive the type of surgery, in order to ensure an unbiased assessment of treatments, randomisation will be performed in eight blocks of five patients. The study groups will be equivalent in all aspects except the procedures they undergo. Participants will be assigned to the first control group without haemofiltration (CG or 1) or one group with haemofiltration using a Polysulfone filter (PG or 2). Data will be collected by a blinded evaluator.
To determine whether continuous ultrafiltration with volume replacement using a polysulfone membrane during Cardiopulmonary Bypass (CPB) in patients undergoing cardiac surgery decreases intraoperative lactatemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
76
The intervention for this group consisted using a Polysulfone filter in order to hemofiltration in the procedure involving Cardiopulmonary Bypass (CPB).The perfusionist's role is essential during the procedure, as they control both Cardiac Output (CO) and gas exchange, depending on their action, will affect blood lactate levels.
In this group, no intervention is performed during the procedure involving Cardiopulmonary Bypass (CPB)
Hospital Puerta del Mar
Cadiz, Spain
Plasma Lactate Level
The lactate level will be measured before Cardiopulmonary Bypass (CPB) in all patients
Time frame: Baseline
Maximum Plasma Lactate Level
The maximum level of intraoperative lactate will be measured in all patients, whether the polysulfone membrane has been used or not during Cardiopulmonary Bypass (CPB)
Time frame: Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB)
Plasma Lactate Level
The level of lactate level will be measured in all patients, whether the polysulfone membrane has been used or not at the end cardiopulmonary bypass (CPB).
Time frame: 1 minute after the Cardiopulmonary Bypass (CPB)
Plasma Lactate Level in the effluent
To determine lactate levels in the effluent in all ultrafiltered patients
Time frame: 1 minute after the Cardiopulmonary Bypass (CPB)
Plasma Lactate Level in intensive care unit (ICU)
Lactate level will be measured 24 hours after surgery in ICU stay
Time frame: 24 hours after the Cardiopulmonary Bypass (CPB)
Serum potassium Level
Serum potassium level measured in routine analysis blood
Time frame: Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB)
Evaluation criteria of mortality and risk profiles of population
Mortality predicted and operative risk will be measured by scoring systems European System for Cardiac Operative Risk Evaluation (EuroSCORE I) in cardiac surgery in all patients
Time frame: 10 minutes before the Cardiopulmonary Bypass (CPB)
Hematocrit
Hematocrit measured in routine analysis blood in all patients
Time frame: Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB)
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