Heart DiseasePhase 2NCT02767154
Dextran-based Priming vs. Crystalloid and Mannitol-based Priming Solution in Adult Cardiac Surgery
A Phase 2 study testing A colloid Dextran 40 solution for extracorporeal circulation and Ringer-Acetate and Mannitol in people with Heart Disease, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
This study will compare two priming solutions for extracorporeal circulation, one based on Dextran 40, one based on crystalloid and mannitol. Primary endpoint is oncotic pressure during cardiopulmonary bypass. Secondary endpoints included fluid balance and organ functions. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Heart Disease
- What is being tested?
- A colloid Dextran 40 solution for extracorporeal circulation and Ringer-Acetate and Mannitol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSweden
- Study dates
- May 2016to 13 Jul 2017
- Phase
- Phase 2
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 - 75 years
- Elective cardiac surgery procedure with expected CBP time above 90 minutes
- Subject provides a legally effective informed consent.
Who cannot join
- Known previous cardiac surgery
- Coagulation disorder
- Malignancy
- Kidney failure
- Liver failure
- Ongoing septicaemia
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- Ongoing antithrombotic treatment other than acetylsalicylic acid
- Systemic inflammatory disorders treated with corticosteroids
- Not able to understand Swedish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing Dextran-based Priming (PrimECC), and Standard Crystalloid and Mannitol-based Priming Solution in Adult Cardiac Surgery
This study will compare two priming solutions for extracorporeal circulation, one based on Dextran 40, one based on crystalloid and mannitol. Primary endpoint is oncotic pressure during cardiopulmonary bypass. Secondary endpoints included fluid balance and organ functions.
Read the detailed description
This is a prospective, single center, double-blinded, randomized controlled clinical trial. Eighty patients are randomized 1:1 to either cardiopulmonary bypass with the dextran-based solution or standard priming with Ringer-Acetate and Mannitol.
Primary endpoint will be oncotic pressure during cardio pulmonary bypass. Secondary endpoints include perioperative fluid balance, coagulation, platelet function, postoperative bleeding volume, transfusion requirements, renal function, liver function, pulmonary function, inflammatory activation and markers for brain and heart injury.
Blood samples for oncotic pressure measurements will be collected from an arterial line before and during surgery. Organ function will be assessed before surgery and 2 hours cardio pulmonary bypass.
- Conditions
- Heart Disease
- Being tested
- A colloid Dextran 40 solution for extracorporeal circulation, Ringer-Acetate and Mannitol
- Keywords
- extracorporeal circulation
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A colloid Dextran 40 solution for extracorporeal circulationDevice
Also called PrimECC
The oncotic pressure of the PrimECC solution is higher than that of a crystalloid Ringer-acetate/mannitol solution. It should maintain the plasma oncotic pressure during and after cardiopulmonary bypass (CPB). Subsequently, the leakage of fluids from the systemic circulation to the interstitial compartment during CPB can be reduced, and a higher plasma volume and a better fluid balance can be achieved.
Ringer-Acetate and MannitolDevice
Also called Standard crystalloid prime
Currently clinic standard for priming the CPB circuit.
| Study group | Role | What they receive |
|---|---|---|
| PrimECC | Active comparator | 1250 ml of a priming solution based on the colloid Dextran 40 to use for extracorporeal circulation. Receives: Device: A colloid Dextran 40 solution for extracorporeal circulation |
| Ringer-Acetate/Mannitol | Active comparator | 1250 ml of a priming solution based on the crystalloid Ringer-Acetate (1000ml) and Mannitol (250ml). Receives: Device: Ringer-Acetate and Mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in oncotic pressure in plasma
The oncotic pressure in plasma is measured using an Osmomat 050 and reported in kPa. Points of measurement is before ECC and at 60 minutes into ECC
Measured: After 1 hour of cardiopulmonary bypass
Secondary outcomes (17)
Change in fluid balance
Patient fluid balance is registered from ECC-start until 24 hours post-ECC. Infusion of crystalloids and colloids and urine output is registered in ml.
Measured: Within 24 hours after cardiopulmonary bypass
Amount of bleeding
Bleeding is registered from ECC-start until 24 hours post-ECC. Intraoperative bleeding and postoperative chest tube drainage for 24 hours are added and registered in ml.
Measured: Within 24 hours after cardiopulmonary bypass
Amount of transfusions
Transfusions of red blood cells, platelets and plasma from ECC-start until 24 hours post-ECC are registered and reported in ml.
Measured: Within 24 hours after cardiopulmonary bypass
Change in coagulation (1).
Blood samples will be analyzed with modified rotational thromboelastometry (ROTEM) and calibrated automated thrombography. Points of measurement will be before ECC and at 2 hours post-ECC. Results will be reported as normal, above normal or below normal.
Measured: Within 2 hours after cardiopulmonary bypass
Change in coagulation (2).
Blood samples will be analyzed calibrated automated thrombography. Points of measurement will be before ECC and at 2 hours post-ECC. Results will be reported as normal, above normal or below normal.
Measured: Within 2 hours after cardiopulmonary bypass
Change in platelet function
Platelet function will be measured with impedance aggregometry (Multiplate). Points of measurement will be before ECC and at 2 hours post-ECC. Results will be reported as normal or below normal.
Measured: Within 2 hours after cardiopulmonary bypass
Change in renal function (1)
Renal function is measured as µmol/L of Creatinine in serum. Points of measurement will be before ECC and at 2 hours post-ECC.
Measured: Within 2 hours after cardiopulmonary bypass
Change in renal function (2)
Renal tubular damage is measured by analysis of U-NAG. Urine is collected before ECC and at 60 minutes into ECC. Results will be reported as U-NAG/U-Creatinine ratio (U/min).
Measured: After 1 hour of cardiopulmonary bypass
Change in liver function (1)
The liver function is measured as µkat/L of ASAT in serum. Points of measurement will be before ECC and at 2 hours post-ECC.
Measured: Within 2 hours after cardiopulmonary bypass
Change in liver function (2)
The liver function is measured as µkat/L of ALAT in serum. Points of measurement will be before ECC and at 2 hours post-ECC.
Measured: Within 2 hours after cardiopulmonary bypass
Change in pulmonary function
The pulmonary function is measured by arterial blood gases assessing PaO2/FiO2 and reported in mmHg. Points of measurement will be before ECC and at 2 hours post-ECC.
Measured: Within 2 hours after cardiopulmonary bypass
Change in ischemic heart injury marker.
The ischemic status of the heart is measures as ng/L of highly sensitive Troponin-T. Points of measurement will be before ECC and at 24 hours post-ECC.
Measured: Within 24 hours after cardiopulmonary bypass
Change in brain injury marker (1)
Brain damage is measured as ng/L Tau in plasma. Points of measurement will be before ECC and at 2 hours post-ECC.
Measured: Within 2 hours after cardiopulmonary bypass
Change in brain injury marker (2)
Brain damage is measured as ng/L of NFL in serum. Points of measurement will be before ECC and at 2 hours post-ECC.
Measured: Within 2 hours after cardiopulmonary bypass
Change in brain injury marker (3)
Brain damage is measured as µg/L of S100B in serum. Points of measurement will be before ECC and at 2 hours post-ECC.
Measured: Within 2 hours after cardiopulmonary bypass
Change in brain injury marker (4)
Brain damage is measured as µg/L of NSE in serum. Points of measurement will be before ECC and at 2 hours post-ECC.
Measured: Within 2 hours after cardiopulmonary bypass
Change in inflammatory activation
Inflammatory activation is measured as ng/L of IL-6 in plasma. Points of measurement will be before ECC and at 2 hours post-ECC.
Measured: Within 2 hours after cardiopulmonary bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startMay 2016
- Primary completion12 Jul 2017
- Study completion13 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Jeppssons, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767154
- Sponsor's protocol ID
- 1003-15
- Status last verified
- Oct 2017
- First submitted
- 12 Apr 2016
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Dextran-based Priming (PrimECC), and Standard Crystalloid and Mannitol-based Priming Solution in Adult Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02767154
- Acronym / sponsor ID
- 1003-15
- Conditions
- Heart Disease
- Keywords
- extracorporeal circulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- 12 Jul 2017 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 10 May 2016 (estimated)
- 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 will compare two priming solutions for extracorporeal circulation, one based on Dextran 40, one based on crystalloid and mannitol. Primary endpoint is oncotic pressure during cardiopulmonary bypass. Secondary endpoints included fluid balance and organ functions.
Detailed description
This is a prospective, single center, double-blinded, randomized controlled clinical trial. Eighty patients are randomized 1:1 to either cardiopulmonary bypass with the dextran-based solution or standard priming with Ringer-Acetate and Mannitol.
Primary endpoint will be oncotic pressure during cardio pulmonary bypass. Secondary endpoints include perioperative fluid balance, coagulation, platelet function, postoperative bleeding volume, transfusion requirements, renal function, liver function, pulmonary function, inflammatory activation and markers for brain and heart injury.
Blood samples for oncotic pressure measurements will be collected from an arterial line before and during surgery. Organ function will be assessed before surgery and 2 hours cardio pulmonary bypass.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrimECC | Active comparator | Device: A colloid Dextran 40 solution for extracorporeal circulation1250 ml of a priming solution based on the colloid Dextran 40 to use for extracorporeal circulation. |
| Ringer-Acetate/Mannitol | Active comparator | Device: Ringer-Acetate and Mannitol1250 ml of a priming solution based on the crystalloid Ringer-Acetate (1000ml) and Mannitol (250ml). |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50 - 75 years
- Elective cardiac surgery procedure with expected CBP time above 90 minutes
- Subject provides a legally effective informed consent.
Key exclusion criteria (9 listed)
- Known previous cardiac surgery
- Coagulation disorder
- Malignancy
- Kidney failure
- Liver failure
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 |
|---|---|---|
| A colloid Dextran 40 solution for extracorporeal circulationAlso: PrimECCThe oncotic pressure of the PrimECC solution is higher than that of a crystalloid Ringer-acetate/mannitol solution. It should maintain the plasma oncotic pressure during and after cardiopulmonary bypass (CPB). Subsequently, the leakage of fluids from the systemic circulation to the interstitial compartment during CPB can be reduced, and a higher plasma volume and a better fluid balance can be achieved. | Device | PrimECC |
| Ringer-Acetate and MannitolAlso: Standard crystalloid primeCurrently clinic standard for priming the CPB circuit. | Device | Ringer-Acetate/Mannitol |
Primary outcome
Change in oncotic pressure in plasma
Time frame: After 1 hour of cardiopulmonary bypass
The oncotic pressure in plasma is measured using an Osmomat 050 and reported in kPa. Points of measurement is before ECC and at 60 minutes into ECC
17 secondary outcomes
Change in fluid balance
Time frame: Within 24 hours after cardiopulmonary bypass
Amount of bleeding
Time frame: Within 24 hours after cardiopulmonary bypass
Amount of transfusions
Time frame: Within 24 hours after cardiopulmonary bypass
Change in coagulation (1).
Time frame: Within 2 hours after cardiopulmonary bypass
Change in coagulation (2).
Time frame: Within 2 hours after cardiopulmonary bypass
Change in platelet function
Time frame: Within 2 hours after cardiopulmonary bypass
Change in renal function (1)
Time frame: Within 2 hours after cardiopulmonary bypass
Change in renal function (2)
Time frame: After 1 hour of cardiopulmonary bypass
Change in liver function (1)
Time frame: Within 2 hours after cardiopulmonary bypass
Change in liver function (2)
Time frame: Within 2 hours after cardiopulmonary bypass
Change in pulmonary function
Time frame: Within 2 hours after cardiopulmonary bypass
Change in ischemic heart injury marker.
Time frame: Within 24 hours after cardiopulmonary bypass
Change in brain injury marker (1)
Time frame: Within 2 hours after cardiopulmonary bypass
Change in brain injury marker (2)
Time frame: Within 2 hours after cardiopulmonary bypass
Change in brain injury marker (3)
Time frame: Within 2 hours after cardiopulmonary bypass
Change in brain injury marker (4)
Time frame: Within 2 hours after cardiopulmonary bypass
Change in inflammatory activation
Time frame: Within 2 hours after cardiopulmonary bypass
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 9 Oct 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing A colloid Dextran 40 solution for extracorporeal circulation and Ringer-Acetate and Mannitol in people with Heart Disease, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 3 inclusion and 9 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 9 Oct 2017. 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 Sweden. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in oncotic pressure in plasma (time frame: After 1 hour of cardiopulmonary bypass). 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 9 Oct 2017.