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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Procedure: Polysulfone Filter; Procedure: Procedure/ Surgery: without Polysulfone Filter

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cadiz, Spain, 11009
    • Hospital Puerta del Mar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Polysulfone Filter Group; 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.	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.
ACTIVE_COMPARATOR: Control Group; 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.	Procedure: Procedure/ Surgery: without Polysulfone Filter; In this group, no intervention is performed during the procedure involving Cardiopulmonary Bypass (CPB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Lactate Level	The lactate level will be measured before Cardiopulmonary Bypass (CPB) in all patients	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Lactate Level	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)	Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB)
Plasma Lactate Level	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).	1 minute after the Cardiopulmonary Bypass (CPB)
Plasma Lactate Level in the effluent	To determine lactate levels in the effluent in all ultrafiltered patients	1 minute after the Cardiopulmonary Bypass (CPB)
Plasma Lactate Level in intensive care unit (ICU)	Lactate level will be measured 24 hours after surgery in ICU stay	24 hours after the Cardiopulmonary Bypass (CPB)
Serum potassium Level	Serum potassium level measured in routine analysis blood	Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB)
Evaluation criteria of mortality and risk profiles of population	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	10 minutes before the Cardiopulmonary Bypass (CPB)
Hematocrit	Hematocrit measured in routine analysis blood in all patients	Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB)

Collaborators and Investigators

• Sponsor: University of Cadiz
• Collaborators: Rocío Martín Valero; Mª José Abellán Hervás; Ana María Sáinz Otero
• Investigators: Principal Investigator: Carlos García Camacho, Degree, University of Cádiz; Study Director: María José Abellán Hervás, PhD, University of Cádiz; Study Director: Rocío Martín Valero, PhD, University of Cádiz; Study Director: Ana María Sáinz Otero, University of Cádiz

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): January 30, 2018
• Study Completion (ACTUAL): February 28, 2018

Study Registration Dates

• First Submitted: January 16, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (ACTUAL): January 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 6, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 160/16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No