The Effect on Fluid Balance After Cardiac Surgery After Use of Two Different Priming Protocols

Haukeland University Hospital

Status and phase: Completed; Phase 2

Conditions: Coronary Heart Disease

Treatments: Drug: acetated Ringer's solution; Drug: Tetraspan

Study type: Interventional

Funder types: Other

Identifiers

NCT01511120

2011/498

Details and patient eligibility

About

"The impact on fluid loading after cardiac surgery by use of two different priming solution"

Fluid overloading with oedema formation is a regular finding following on-pump cardiac surgery and may contribute to postoperative organ dysfunction. Myocardial oedema has been reported to impair both systolic and diastolic function. An association between intraoperative fluid loading and postoperative adverse outcome has been demonstrated in cardiac patients.

The investigators have experience with the use of both colloides and combination fluids (hypertonic saline/colloides) in several experimental studies (pigs). In one animal study the investigators used colloides as an additive to the CPB-prime. The investigators observed reduced fluid leakage and less total tissue water in several organs.

The planned study includes patients scheduled for coronary artery bypass, and who have no co-morbidity. The patients will be randomized to receive either Tetraspan® (HES) or acetated Ringer's solution in the CPB-prime. Accurate accounts of fluid additions, blood loss and diuresis will be kept. Determination of cardiac output (C.O.), intrathoracic blood volume (ITBV), extravascular lung water (EVLW) and global end diastolic volume (GEDV) will be monitored by use of the transpulmonary thermodilution technique PiCCO®plus system.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing CABG,
• EF(ejection fraction) more than 40%

Exclusion criteria

• Reduced EF (less than 40%) EVF less than 30%,
• Estimated GFR less than 60%,
• BMI less than 18 or more than 32

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Triple Blind

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40 participants in 1 patient group

Tetraspan

Active Comparator group

Treatment:

Drug: acetated Ringer's solution

Drug: Tetraspan