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Slow recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colloid priming solution for ECC circuit | Experimental | Priming of ECC circuit with approximately 1200 mL PrimECC. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colloid priming solution for ECC circuit | Device | Prospective, multi-center, double-blinded, randomized, controlled clinical trial |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Within 96 hours after ICU arrival |
| Measure | Description | Time Frame |
|---|---|---|
| NAG excretion | NAG-excretion (U-NAG/U-creatinine) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative bleeding | Drain losses | The first 24 hours after disconnection from ECC |
| Post-operative transfusions and use of hemostatic agents | Total transfusions and/or use of erythrocytes, plasma, thrombocytes, hemostatic pharmaceuticals |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lukas Lannemyr, MD,PhD | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | Västra Götaland County | 41251 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41144782 | Derived | 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. |
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Individual participant data will not be shared with other researchers
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Standard priming solution for ECC circuit | Device | Prospective, multi-center, double-blinded, randomized, controlled clinical trial |
|
| Pre-operative and within 96 hours after ICU arrival |
| Incidence of AKI | Incidence of AKI of different stages according to the KDIGO creatinine criteria | Within 96 hours after ICU arrival |
| Hemolysis | Hemolysis measured as free hemoglobin (PfHb) | 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 | 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 | Pre-operative (after induction of anesthesia) and at 1 hour after discontinuation of ECC and 24 hours after disconnection from ECC. |
| The first 24 hours after disconnection from ECC |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |