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NCT Number: NCT03412968

Continuous Hemofiltration During Cardiopulmonary Bypass and Its Effect on Lactatemia

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Puerta del Mar

Cadiz, 11009, Spain

About this study

To determine whether continuous ultrafiltration with volume replacement using a polysulfone membrane during Cardiopulmonary Bypass (CPB) in patients undergoing cardiac surgery decreases intraoperative lactatemia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Procedure/ Surgery: without Polysulfone Filter

Procedure

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

Primary outcomes

  1. Plasma Lactate Level

    Time frame: Baseline

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

Secondary outcomes

  1. Maximum Plasma Lactate Level

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

    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)

  2. Plasma Lactate Level

    Time frame: 1 minute after the Cardiopulmonary Bypass (CPB)

    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).

  3. Plasma Lactate Level in the effluent

    Time frame: 1 minute after the Cardiopulmonary Bypass (CPB)

    To determine lactate levels in the effluent in all ultrafiltered patients

  4. Plasma Lactate Level in intensive care unit (ICU)

    Time frame: 24 hours after the Cardiopulmonary Bypass (CPB)

    Lactate level will be measured 24 hours after surgery in ICU stay

  5. Serum potassium Level

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

    Serum potassium level measured in routine analysis blood

  6. Evaluation criteria of mortality and risk profiles of population

    Time frame: 10 minutes before the Cardiopulmonary Bypass (CPB)

    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

  7. Hematocrit

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

    Hematocrit measured in routine analysis blood in all patients

Sponsors and collaborators

Lead sponsor

University of Cadiz

Other

Collaborators

  • Ana María Sáinz Otero
  • Mª José Abellán Hervás
  • Rocío Martín Valero

Registry information

Official study title

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

Acronym: CPB-LACTATE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 29, 2018
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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