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Completed

NCT Number: NCT02767154

Dextran-based Priming vs. 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.

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Key information

Conditions

Heart Disease Cardiovascular Diseases Heart Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sahlgrenska University Hospital

Gothenburg, VGR, 41345, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 50 - 75 years
  • Elective cardiac surgery procedure with expected CBP time above 90 minutes
  • Subject provides a legally effective informed consent.

Exclusion criteria

  • Known previous cardiac surgery
  • Coagulation disorder
  • Malignancy
  • Kidney failure
  • Liver failure
  • Ongoing septicaemia
  • Ongoing antithrombotic treatment other than acetylsalicylic acid
  • Systemic inflammatory disorders treated with corticosteroids
  • Not able to understand Swedish

Treatment and study plan

A colloid Dextran 40 solution for extracorporeal circulation

Device

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.

Other names: PrimECC

Ringer-Acetate and Mannitol

Device

Currently clinic standard for priming the CPB circuit.

Other names: Standard crystalloid prime

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in fluid balance

    Time frame: Within 24 hours after cardiopulmonary bypass

    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.

  2. Amount of bleeding

    Time frame: Within 24 hours after cardiopulmonary bypass

    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.

  3. Amount of transfusions

    Time frame: Within 24 hours after cardiopulmonary bypass

    Transfusions of red blood cells, platelets and plasma from ECC-start until 24 hours post-ECC are registered and reported in ml.

  4. Change in coagulation (1).

    Time frame: Within 2 hours after cardiopulmonary bypass

    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.

  5. Change in coagulation (2).

    Time frame: Within 2 hours after cardiopulmonary bypass

    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.

  6. Change in platelet function

    Time frame: Within 2 hours after cardiopulmonary bypass

    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.

  7. Change in renal function (1)

    Time frame: Within 2 hours after cardiopulmonary bypass

    Renal function is measured as µmol/L of Creatinine in serum. Points of measurement will be before ECC and at 2 hours post-ECC.

  8. Change in renal function (2)

    Time frame: After 1 hour of cardiopulmonary bypass

    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).

  9. Change in liver function (1)

    Time frame: Within 2 hours after cardiopulmonary bypass

    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.

  10. Change in liver function (2)

    Time frame: Within 2 hours after cardiopulmonary bypass

    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.

  11. Change in pulmonary function

    Time frame: Within 2 hours after cardiopulmonary bypass

    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.

  12. Change in ischemic heart injury marker.

    Time frame: Within 24 hours after cardiopulmonary bypass

    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.

  13. Change in brain injury marker (1)

    Time frame: Within 2 hours after cardiopulmonary bypass

    Brain damage is measured as ng/L Tau in plasma. Points of measurement will be before ECC and at 2 hours post-ECC.

  14. Change in brain injury marker (2)

    Time frame: Within 2 hours after cardiopulmonary bypass

    Brain damage is measured as ng/L of NFL in serum. Points of measurement will be before ECC and at 2 hours post-ECC.

  15. Change in brain injury marker (3)

    Time frame: Within 2 hours after cardiopulmonary bypass

    Brain damage is measured as µg/L of S100B in serum. Points of measurement will be before ECC and at 2 hours post-ECC.

  16. Change in brain injury marker (4)

    Time frame: Within 2 hours after cardiopulmonary bypass

    Brain damage is measured as µg/L of NSE in serum. Points of measurement will be before ECC and at 2 hours post-ECC.

  17. Change in inflammatory activation

    Time frame: Within 2 hours after cardiopulmonary bypass

    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.

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

A Randomized Controlled Trial Comparing Dextran-based Priming (PrimECC), and Standard Crystalloid and Mannitol-based Priming Solution in Adult Cardiac Surgery

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 10, 2016
Registry last updated
Oct 9, 2017

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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