Cardiovascular DiseasesCPB-LACTATENCT03412968
Continuous Hemofiltration During Cardiopulmonary Bypass and Its Effect on Lactatemia
A study testing Polysulfone Filter and Procedure/ Surgery: without Polysulfone Filter in people with Cardiovascular Diseases, run by University of Cadiz at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Polysulfone Filter and Procedure/ Surgery: without Polysulfone Filter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2017to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Polysulfone Filter, Procedure/ Surgery: without Polysulfone Filter
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polysulfone FilterProcedure or surgery
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 FilterProcedure or surgery
In this group, no intervention is performed during the procedure involving Cardiopulmonary Bypass (CPB)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Procedure/ Surgery: without Polysulfone Filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Lactate Level
The lactate level will be measured before Cardiopulmonary Bypass (CPB) in all patients
Measured: Baseline
Secondary outcomes (7)
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)
Measured: 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).
Measured: 1 minute after the Cardiopulmonary Bypass (CPB)
Plasma Lactate Level in the effluent
To determine lactate levels in the effluent in all ultrafiltered patients
Measured: 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
Measured: 24 hours after the Cardiopulmonary Bypass (CPB)
Serum potassium Level
Serum potassium level measured in routine analysis blood
Measured: 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
Measured: 10 minutes before the Cardiopulmonary Bypass (CPB)
Hematocrit
Hematocrit measured in routine analysis blood in all patients
Measured: Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start1 Sep 2017
- Primary completion30 Jan 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Collaborators
- Mª José Abellán Hervás, Valero, Rocío Martín, Ph.D., Ana María Sáinz Otero
- Responsible party
- Principal investigator, Carlos Garcia Camacho, University of Cadiz
- Investigators
- Carlos García Camacho, Degree, Principal investigator, University of CadizMaría José Abellán Hervás, PhD, Study director, University of CadizRocío Martín Valero, PhD, Study director, University of CadizAna María Sáinz Otero, Study director, University of Cadiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412968
- Sponsor's protocol ID
- 160/16
- Acronym
- CPB-LACTATE
- Status last verified
- May 2018
- First submitted
- 16 Jan 2018
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Polysulfone Membranes on Continuous Ultrafiltration With Volume Replacement in Patients Undergoing Cardiac
- ClinicalTrials.gov ID
- NCT03412968
- Acronym / sponsor ID
- CPB-LACTATE / 160/16
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Collaborators
- Mª José Abellán Hervás, Valero, Rocío Martín, Ph.D., Ana María Sáinz Otero
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Polysulfone Filter Group | Experimental | Procedure: Polysulfone FilterThe 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. |
| Control Group | Active comparator | Procedure: Procedure/ Surgery: without Polysulfone FilterThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polysulfone FilterThe 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 or surgery | Polysulfone Filter Group |
| Procedure/ Surgery: without Polysulfone FilterIn this group, no intervention is performed during the procedure involving Cardiopulmonary Bypass (CPB) | Procedure or surgery | Control Group |
Primary outcome
Plasma Lactate Level
Time frame: Baseline
The lactate level will be measured before Cardiopulmonary Bypass (CPB) in all patients
7 secondary outcomes
Maximum Plasma Lactate Level
Time frame: Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB)
Plasma Lactate Level
Time frame: 1 minute after the Cardiopulmonary Bypass (CPB)
Plasma Lactate Level in the effluent
Time frame: 1 minute after the Cardiopulmonary Bypass (CPB)
Plasma Lactate Level in intensive care unit (ICU)
Time frame: 24 hours after the Cardiopulmonary Bypass (CPB)
Serum potassium Level
Time frame: Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB)
Evaluation criteria of mortality and risk profiles of population
Time frame: 10 minutes before the Cardiopulmonary Bypass (CPB)
Hematocrit
Time frame: Every 20 minutes from the start of the Cardiopulmonary Bypass (CPB)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos García Camacho, Degree principal investigator
University of Cadiz
María José Abellán Hervás, PhD study director
University of Cadiz
Rocío Martín Valero, PhD study director
University of Cadiz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysulfone Filter and Procedure/ Surgery: without Polysulfone Filter in people with Cardiovascular Diseases, run by University of Cadiz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Lactate Level (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.