Clinical trial NCT03412968: Continuous Hemofiltration During Cardiopulmonary Bypass and Its Effect on Lactatemia
Official title: Using Polysulfone Membranes on Continuous Ultrafiltration With Volume Replacement in Patients Undergoing Cardiac
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: University of Cadiz
Sponsor class: OTHER
Collaborators: name: Mª José Abellán Hervás
name: Rocío Martín Valero
name: Ana María Sáinz Otero
First posted: 2018-01-29
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Plasma Lactate Level
timeFrame: Baseline
Secondary outcomes:
measure: Maximum Plasma Lactate Level
timeFrame: Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB)
measure: Plasma Lactate Level
timeFrame: 1 minute after the Cardiopulmonary Bypass (CPB)
measure: Plasma Lactate Level in the effluent
timeFrame: 1 minute after the Cardiopulmonary Bypass (CPB)
measure: Plasma Lactate Level in intensive care unit (ICU)
timeFrame: 24 hours after the Cardiopulmonary Bypass (CPB)
measure: Serum potassium Level
timeFrame: Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB)
measure: Evaluation criteria of mortality and risk profiles of population
timeFrame: 10 minutes before the Cardiopulmonary Bypass (CPB)
measure: Hematocrit
timeFrame: Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB)
Other outcomes:
Locations:
city: Cadiz
country: Spain
facility: Hospital Puerta del Mar
Study officials:
affiliation: University of Cadiz
name: Carlos García Camacho, Degree
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cadiz
name: María José Abellán Hervás, PhD
role: STUDY_DIRECTOR
affiliation: University of Cadiz
name: Rocío Martín Valero, PhD
role: STUDY_DIRECTOR
affiliation: University of Cadiz
name: Ana María Sáinz Otero
role: STUDY_DIRECTOR
References: