NCT03412968

Continuous Hemofiltration During Cardiopulmonary Bypass and Its Effect on Lactatemia

Using Polysulfone Membranes on Continuous Ultrafiltration With Volume Replacement in Patients Undergoing Cardiac

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: University of Cadiz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-01-30
• Completion: 2018-02-28
• First posted: 2018-01-29
• Last updated: 2018-05-11

Locations

1 site across 1 country: Spain