Continuous Hemofiltration During Cardiopulmonary Bypass and Its Effect on Lactatemia

NCT ID: NCT03412968

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Polysulfone Filter

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Procedure/ Surgery: without Polysulfone Filter

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Procedure/ Surgery: without Polysulfone Filter

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

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mª José Abellán Hervás

UNKNOWN

Sponsor Role: collaborator

Rocío Martín Valero

UNKNOWN

Sponsor Role: collaborator

Ana María Sáinz Otero

UNKNOWN

Sponsor Role: collaborator

University of Cadiz

OTHER

Sponsor Role: lead

Responsible Party

Carlos Garcia Camacho

MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos García Camacho, Degree

Role: PRINCIPAL_INVESTIGATOR

University of Cadiz

María José Abellán Hervás, PhD

Role: STUDY_DIRECTOR

University of Cadiz

Rocío Martín Valero, PhD

Role: STUDY_DIRECTOR

University of Cadiz

Ana María Sáinz Otero

Role: STUDY_DIRECTOR

University of Cadiz

Locations

Hospital Puerta del Mar

Cadiz, , Spain

Countries

Spain

Other Identifiers

160/16

Identifier Type: -

Identifier Source: org_study_id