Cardiovascular Diseases
Conditions
Brief summary
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.
Detailed description
To determine whether continuous ultrafiltration with volume replacement using a polysulfone membrane during Cardiopulmonary Bypass (CPB) in patients undergoing cardiac surgery decreases intraoperative lactatemia.
Interventions
PROCEDUREPolysulfone Filter
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.
PROCEDUREProcedure/ Surgery: without Polysulfone Filter
In this group, no intervention is performed during the procedure involving Cardiopulmonary Bypass (CPB)
Sponsors
Mª José Abellán Hervás
Rocío Martín Valero
Ana María Sáinz Otero
University of Cadiz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
The perfusionist's role is essential during the procedure involving Cardiopulmonary Bypass (CPB). This study purpose to know 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 and blood lactate levels during the procedure.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who signed informed consent * Patients not undergoing emergency surgery. * Surgical procedures performed under normothermic conditions. * Patients with a minimum time of 40 minutes before decannulation (after the end of myocardial reperfusion, unclamping of the aorta and the end of CPB).
Exclusion criteria
* Emergency medical condition in which it is not possible to collect study data. * Heart condition requiring the use of hypothermia or hyperthermia during CPB. * Patients without a minimum time of 40 minutes before decannulation (after the end of myocardial reperfusion, unclamping of the aorta and the end of CPB). * Patients who cannot manage their fluid balance on their own through diuresis prior to CPB. * Patients who are unable to manage excess volume during the surgical procedure by means of spontaneous or forced diuresis with diuretics (positive cumulative balance despite intravenous bolus of diuretics after 75% of the anticipated duration of CPB according to the course of the surgery).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Lactate Level | Baseline | The lactate level will be measured before Cardiopulmonary Bypass (CPB) in all patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Lactate Level | 1 minute after the Cardiopulmonary Bypass (CPB) | 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). |
| Plasma Lactate Level in the effluent | 1 minute after the Cardiopulmonary Bypass (CPB) | To determine lactate levels in the effluent in all ultrafiltered patients |
| Plasma Lactate Level in intensive care unit (ICU) | 24 hours after the Cardiopulmonary Bypass (CPB) | Lactate level will be measured 24 hours after surgery in ICU stay |
| Maximum Plasma Lactate Level | Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB) | 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) |
| Evaluation criteria of mortality and risk profiles of population | 10 minutes before the Cardiopulmonary Bypass (CPB) | 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 |
| Hematocrit | Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB) | Hematocrit measured in routine analysis blood in all patients |
| Serum potassium Level | Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB) | Serum potassium level measured in routine analysis blood |
Countries
Spain
Outcome results
None listed