Continuous Hemofiltration During Cardiopulmonary Bypass and Its Effect on Lactatemia

Cardiovascular Diseases Clinical Trial

— CPB-LACTATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03412968
• Other study ID #: 160/16
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: May 2018
• Source: University of Cadiz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: February 28, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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/ Surgery: without Polysulfone Filter
In this group, no intervention is performed during the procedure involving Cardiopulmonary Bypass (CPB)

Locations

Country	Name	City	State
Spain	Hospital Puerta del Mar	Cadiz

Sponsors (4)

Lead Sponsor	Collaborator
University of Cadiz	Ana María Sáinz Otero, Mª José Abellán Hervás, Rocío Martín Valero

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Lactate Level	The lactate level will be measured before Cardiopulmonary Bypass (CPB) in all patients	Baseline
Secondary	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)
Secondary	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)
Secondary	Plasma Lactate Level in the effluent	To determine lactate levels in the effluent in all ultrafiltered patients	1 minute after the Cardiopulmonary Bypass (CPB)
Secondary	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)
Secondary	Serum potassium Level	Serum potassium level measured in routine analysis blood	Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB)
Secondary	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)
Secondary	Hematocrit	Hematocrit measured in routine analysis blood in all patients	Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB)