Continuous Hemofiltration During Cardiopulmonary Bypass and Its Effect on Lactatemia

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.

Conditions

• Cardiovascular Diseases

Interventions

PROCEDURE

Polysulfone 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.

PROCEDURE

Procedure/ Surgery: without Polysulfone Filter

In this group, no intervention is performed during the procedure involving Cardiopulmonary Bypass (CPB)

Sponsors & Collaborators

• Mª José Abellán Hervás

  collaborator UNKNOWN

• Rocío Martín Valero

  collaborator UNKNOWN

• Ana María Sáinz Otero

  collaborator UNKNOWN

• University of Cadiz

  lead OTHER

Principal Investigators

• Carlos García Camacho, Degree · University of Cadiz

• María José Abellán Hervás, PhD · University of Cadiz

• Rocío Martín Valero, PhD · University of Cadiz

• Ana María Sáinz Otero · University of Cadiz

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-01

Primary Completion

2018-01-30

Completion

2018-02-28

Countries

• Spain

Study Locations