Cardiac Surgical ProceduresNCT04293744
Acute Kidney Injury After Cardiac Surgery
A study testing Colloid priming solution for ECC circuit and Standard priming solution for ECC circuit in people with Cardiac Surgical Procedures and Extracorporeal Circulation; Complications, run by XVIVO Perfusion at 1 site in Sweden.
Trial summary
PrimECC is a colloid priming solution for cardiopulmonary bypass/ extracorporeal circulation (ECC) based on Ringers Lactate, supplmeneted with Dextran 40 and Dextran 1. In a previous RCT comparing PrimECC with crystalloid priming fluid, patients in the PrimECC group experienced less hemolysis, less tubular cell injury… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgical Procedures, Extracorporeal Circulation; Complications, Acute Kidney Injury
- What is being tested?
- Colloid priming solution for ECC circuit and Standard priming solution for ECC circuit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 4 Sep 2020to 31 Oct 2023
- 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
- Has signed and dated the EC approved informed consent
- Subject is ≥ 18 years of age
- Requires elective or urgent (non-emergency) cardiac procedure requiring the use of ECC.
- Preoperative "Acute kidney injury risk score" ≥30%, found at http://cardiacsurgeryleicester.com/our-research/acute-kidney-injury-risk-score-calculator/
Who cannot join
- Unable to give informed consent
- Known bleeding disorder
- Known intolerance or contraindication to dextran
- Acute Surgery (requires emergency cardiac procedure/surgery)
- Currently using an antithrombotic medication which has not been discontinued per institution protocol
- Malignancy; Surgery within 5 years or ongoing antitumoral treatment
- Has ongoing sepsis or endocarditis
- Requires pre-operative dialysis
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 41251
About this study
Official title: Acute Kidney Injury After Cardiac Surgery; A Prospective Randomized Study of Dextran Based and Crystalloid Priming Solutions (PRIMING II Trial)
PrimECC is a colloid priming solution for cardiopulmonary bypass/ extracorporeal circulation (ECC) based on Ringers Lactate, supplmeneted with Dextran 40 and Dextran 1. In a previous RCT comparing PrimECC with crystalloid priming fluid, patients in the PrimECC group experienced less hemolysis, less tubular cell injury and beneficial effect on the fluid balance. This study will investigate if, in a population at high risk of acute kidney injury (AKI), priming the ECC circuit with PrimECC instead of crystalloid solution will lead to a reduction of postoperative AKI. The hypothesis is that PrimECC, compared to crystalloid prime, will reduce postoperative AKI.
The study is a Swedish multicenter, double-blinded, randomized, controlled clinical trial. The trial will include 366 patients aged ≥18 years, scheduled for cardiac surgery with cardiopulmonary bypass, with an "Acute kidney injury risk score" ≥30% according to Birnie et al. (2014). The primary outcome of the study is the incidence of postoperative AKI of any stage according to the KDIGO creatinine criteria (serum-creatinine increase ≥ 27 μmol/l within 48 h or ≥ 50 % increase from baseline) within 96 hours after arrival to the ICU. Secondary outcomes are between-group differences in hemolysis, tubular cell injury (NAG-excretion), estimated GFR, and incidence of AKI of different stages according to the KDIGO creatinine criteria. In addition, differences in CNS (Tau, NFL, NSE, and S100B) and cardiac (TNT/TNI) injury markers will be investigated.
- Conditions
- Cardiac Surgical Procedures, Extracorporeal Circulation; Complications, Acute Kidney Injury
- Being tested
- Colloid priming solution for ECC circuit, Standard priming solution for ECC circuit
- Keywords
- Colloid priming solution, Cardiopulmonary bypass, Extracorporeal circulation, ECC, Acute Kidney Injury, AKI
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colloid priming solution for ECC circuitDevice
Prospective, multi-center, double-blinded, randomized, controlled clinical trial
Standard priming solution for ECC circuitDevice
Prospective, multi-center, double-blinded, randomized, controlled clinical trial
| Study group | Role | What they receive |
|---|---|---|
| Colloid priming solution for ECC circuit | Experimental | Priming of ECC circuit with approximately 1200 mL PrimECC. Receives: Device: Colloid priming solution for ECC circuit |
| Standard priming solution for ECC circuit | Active comparator | Priming of ECC circuit with approximately 1200 mL standard priming solution (crystalloid solution with or without mannitol addition as per routine of the participating clinic). Receives: Device: Standard priming solution for ECC circuit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-operative AKI
Incidence of postoperative AKI of any stage according to the KDIGO creatinine criteria (serum-creatinine increase ≥ 27 μmol/l within 48 hours or ≥ 50 % increase from baseline)
Measured: Within 96 hours after ICU arrival
Secondary outcomes (6)
NAG excretion
NAG-excretion (U-NAG/U-creatinine)
Measured: 1 hour post initiation of ECC, at 1 hour after disconnection from ECC and 24 hours after disconnection from ECC.
eGFR
pre-operative (day before surgery) compared to the highest post-operative value Measured value of pre-operative eGFR compared to the highest post-operative value within 96 hours after ICU arrival, calculated using the CKD-EPI formula
Measured: Pre-operative and within 96 hours after ICU arrival
Incidence of AKI
Incidence of AKI of different stages according to the KDIGO creatinine criteria
Measured: Within 96 hours after ICU arrival
Hemolysis
Hemolysis measured as free hemoglobin (PfHb)
Measured: Pre-operative (after induction of anesthesia) and at 1 hour post initiation of ECC, 1 hour after disconnection from ECC and at 24 hours after disconnection from ECC.
CNS injury markers
Measured concentrations of CNS injury markers Tau, NFL, NSE, and S100B
Measured: Pre-operative (after induction of anesthesia), 1 hour after disconnection from ECC and at 24 hours after disconnection from ECC.
Myocardial injury markers
Measured concentrations of myocardial injury markers TnI or TnT. TnI or TnT is chosen according to institutional standard
Measured: Pre-operative (after induction of anesthesia) and at 1 hour after discontinuation of ECC and 24 hours after disconnection from ECC.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start4 Sep 2020
- Primary completion31 Aug 2023
- Study completion31 Oct 2023
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Surgical ProceduresStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- XVIVO Perfusion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lukas Lannemyr, MD,PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293744
- Sponsor's protocol ID
- Priming II Trial
- Status last verified
- Nov 2023
- First submitted
- 17 Jan 2020
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers
Publications
Juvakka O, Wallinder A, Moller-Sorensen PH, Matschke K, Jeppsson A, Lannemyr L. Dextran vs. Crystalloid Priming Solution in Cardiac Surgery: A Randomized Trial on Acute Kidney Injury. Acta Anaesthesiol Scand. 2026 Jan;70(1):e70139. doi: 10.1111/aas.70139.
PubMed 41144782
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury After Cardiac Surgery; A Prospective Randomized Study of Dextran Based and Crystalloid Priming Solutions (PRIMING II Trial)
- ClinicalTrials.gov ID
- NCT04293744
- Acronym / sponsor ID
- Priming II Trial
- Conditions
- Cardiac Surgical Procedures, Extracorporeal Circulation; Complications, Acute Kidney Injury
- Keywords
- Colloid priming solution, Cardiopulmonary bypass, Extracorporeal circulation, ECC, Acute Kidney Injury, AKI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 100 participants (actual)
- Lead sponsor
- XVIVO PerfusionIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 3 Mar 2020 (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.
PrimECC is a colloid priming solution for cardiopulmonary bypass/ extracorporeal circulation (ECC) based on Ringers Lactate, supplmeneted with Dextran 40 and Dextran 1. In a previous RCT comparing PrimECC with crystalloid priming fluid, patients in the PrimECC group experienced less hemolysis, less tubular cell injury and beneficial effect on the fluid balance. This study will investigate if, in a population at high risk of acute kidney injury (AKI), priming the ECC circuit with PrimECC instead of crystalloid solution will lead to a reduction of postoperative AKI. The hypothesis is that PrimECC, compared to crystalloid prime, will reduce postoperative AKI.
The study is a Swedish multicenter, double-blinded, randomized, controlled clinical trial. The trial will include 366 patients aged ≥18 years, scheduled for cardiac surgery with cardiopulmonary bypass, with an "Acute kidney injury risk score" ≥30% according to Birnie et al. (2014). The primary outcome of the study is the incidence of postoperative AKI of any stage according to the KDIGO creatinine criteria (serum-creatinine increase ≥ 27 μmol/l within 48 h or ≥ 50 % increase from baseline) within 96 hours after arrival to the ICU. Secondary outcomes are between-group differences in hemolysis, tubular cell injury (NAG-excretion), estimated GFR, and incidence of AKI of different stages according to the KDIGO creatinine criteria. In addition, differences in CNS (Tau, NFL, NSE, and S100B) and cardiac (TNT/TNI) injury markers will be investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colloid priming solution for ECC circuit | Experimental | Device: Colloid priming solution for ECC circuitPriming of ECC circuit with approximately 1200 mL PrimECC. |
| Standard priming solution for ECC circuit | Active comparator | Device: Standard priming solution for ECC circuitPriming of ECC circuit with approximately 1200 mL standard priming solution (crystalloid solution with or without mannitol addition as per routine of the participating clinic). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has signed and dated the EC approved informed consent
- Subject is ≥ 18 years of age
- Requires elective or urgent (non-emergency) cardiac procedure requiring the use of ECC.
- Preoperative "Acute kidney injury risk score" ≥30%, found at http://cardiacsurgeryleicester.com/our-research/acute-kidney-injury-risk-score-calculator/
Key exclusion criteria (8 listed)
- Unable to give informed consent
- Known bleeding disorder
- Known intolerance or contraindication to dextran
- Acute Surgery (requires emergency cardiac procedure/surgery)
- Currently using an antithrombotic medication which has not been discontinued per institution protocol
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 |
|---|---|---|
| Colloid priming solution for ECC circuitProspective, multi-center, double-blinded, randomized, controlled clinical trial | Device | Colloid priming solution for ECC circuit |
| Standard priming solution for ECC circuitProspective, multi-center, double-blinded, randomized, controlled clinical trial | Device | Standard priming solution for ECC circuit |
Primary outcome
Incidence of post-operative AKI
Time frame: Within 96 hours after ICU arrival
Incidence of postoperative AKI of any stage according to the KDIGO creatinine criteria (serum-creatinine increase ≥ 27 μmol/l within 48 hours or ≥ 50 % increase from baseline)
6 secondary outcomes
NAG excretion
Time frame: 1 hour post initiation of ECC, at 1 hour after disconnection from ECC and 24 hours after disconnection from ECC.
eGFR
Time frame: Pre-operative and within 96 hours after ICU arrival
Incidence of AKI
Time frame: Within 96 hours after ICU arrival
Hemolysis
Time frame: Pre-operative (after induction of anesthesia) and at 1 hour post initiation of ECC, 1 hour after disconnection from ECC and at 24 hours after disconnection from ECC.
CNS injury markers
Time frame: Pre-operative (after induction of anesthesia), 1 hour after disconnection from ECC and at 24 hours after disconnection from ECC.
Myocardial injury markers
Time frame: Pre-operative (after induction of anesthesia) and at 1 hour after discontinuation of ECC and 24 hours after disconnection from ECC.
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Derived from this study: PubMed 41144782Juvakka O, Wallinder A, Moller-Sorensen PH, Matschke K, Jeppsson A, Lannemyr L. Dextran vs. Crystalloid Priming Solution in Cardiac Surgery: A Randomized Trial on Acute Kidney Injury. Acta Anaesthesiol Scand. 2026 Jan;70(1):e70139. doi: 10.1111/aas.70139.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers
Related trials for Cardiac Surgical Procedures
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
Not yet recruiting
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Chest Tube Removal
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
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.
Lukas Lannemyr, MD,PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colloid priming solution for ECC circuit and Standard priming solution for ECC circuit in people with Cardiac Surgical Procedures and Extracorporeal Circulation; Complications, run by XVIVO Perfusion 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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 6 Dec 2023. 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.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
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?
Incidence of post-operative AKI (time frame: Within 96 hours after ICU arrival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04293744, which also lists 1 linked publication.
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 6 Dec 2023.