Dextran-based Priming vs. Crystalloid and Mannitol-based Priming Solution in Adult Cardiac Surgery

S

Sahlgrenska University Hospital

Status and phase

Completed
Phase 2

Conditions

Heart Disease

Treatments

Device: A colloid Dextran 40 solution for extracorporeal circulation
Device: Ringer-Acetate and Mannitol

Study type

Interventional

Funder types

Other

Identifiers

NCT02767154
1003-15

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

84 participants in 2 patient groups

PrimECC
Active Comparator group
Description:
1250 ml of a priming solution based on the colloid Dextran 40 to use for extracorporeal circulation.
Treatment:
Device: A colloid Dextran 40 solution for extracorporeal circulation
Ringer-Acetate/Mannitol
Active Comparator group
Description:
1250 ml of a priming solution based on the crystalloid Ringer-Acetate (1000ml) and Mannitol (250ml).
Treatment:
Device: Ringer-Acetate and Mannitol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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