Continuous Hemofiltration During Cardiopulmonary Bypass and Its Effect on Lactatemia (CPB-LACTATE)

University of Cadiz

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Procedure: Polysulfone Filter; Procedure: Procedure/ Surgery: without Polysulfone Filter

Study type: Interventional

Funder types: Other

Identifiers

NCT03412968

160/16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 2 patient groups

Polysulfone Filter Group

Experimental group

Description:

The purpose of the research is to determine whether, by controlling the patient's hemodilution level and, therefore, the acute anaemia caused by the Cardiopulmonary Bypass (CPB) priming fluid, continuous conventional ultrafiltration (CUF) can decrease serum lactate levels during normothermic CPB by increasing the haematocrit and, consequently, the supply of oxygen to the tissues, and whether the haemofiltration membrane can remove lactate molecules in situations of hyperlactataemia in CPB.

Treatment:

Procedure: Polysulfone Filter

Control Group

Active Comparator group

Description:

The purpose of the research is to determine serum lactate levels during normothermic cardiopulmonary bypass procedure (CPB) without continuous hemofiltration of the patient during the CPB.

Treatment:

Procedure: Procedure/ Surgery: without Polysulfone Filter