Continuous Hemofiltration During Cardiopulmonary Bypass and Its Effect on Lactatemia

NCT03412968 | Completed DMC

• 1 other identifier: 160/16
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Plasma Lactate Level

  The lactate level will be measured before Cardiopulmonary Bypass (CPB) in all patients

  Baseline

Secondary Outcomes (7)

• Maximum Plasma Lactate Level

  Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB)

• Plasma Lactate Level

  1 minute after the Cardiopulmonary Bypass (CPB)

• Plasma Lactate Level in the effluent

  1 minute after the Cardiopulmonary Bypass (CPB)

• Plasma Lactate Level in intensive care unit (ICU)

  24 hours after the Cardiopulmonary Bypass (CPB)

• Serum potassium Level

  Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB)

Study Arms (2)

Polysulfone Filter Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Polysulfone Filter 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.

Polysulfone Filter Group

Procedure/ Surgery: without Polysulfone Filter PROCEDURE

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Cadiz: lead
• Mª José Abellán Hervás: collaborator
• Rocío Martín Valero: collaborator
• Ana María Sáinz Otero: collaborator

Study Sites (1)

Hospital Puerta del Mar

Cadiz, 11009, Spain

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Surgical Procedures, Operative

Study Officials

• Carlos García Camacho, Degree

  University of Cadiz

  PRINCIPAL INVESTIGATOR

• María José Abellán Hervás, PhD

  University of Cadiz

  STUDY DIRECTOR

• Rocío Martín Valero, PhD

  University of Cadiz

  STUDY DIRECTOR

• Ana María Sáinz Otero

  University of Cadiz

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Model Details: The perfusionist's role is essential during the procedure involving Cardiopulmonary Bypass (CPB). This study purpose to know 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 and blood lactate levels during the procedure.

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: January 29, 2018
• Study Start: September 1, 2017
• Primary Completion: January 30, 2018
• Study Completion: February 28, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

ES (1)