Elective Cardiac Surgery
Conditions
Keywords
Cardiac surgery, Balanced 3rd generation Hydroxyethyl starch, Tetraspan, Ringer-albumin
Brief summary
The purpose of this randomized controlled trial in patients undergoing cardiac surgery is to show that a 3rd generation HES (Hydroxyethyl Starch) solution - Tetraspan® is as good as in terms of safety and effectiveness as the commonly used albumin based solution for volume replacement after the surgery.
Interventions
DRUGBalanced hydroxyethyl starch solution
Patients receiving Tetraspan 6% ( a balanced 3rd generation Hydroxyethyl starch)for volume replacement after elective cardiac surgery as needed.
DRUGRinger- albumin
Patients receiving lactated ringer-albumin solution for volume replacement after cardiac surgery
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent must be obtained from the subject or his/her legal guardian before any assessment is performed. * Male or Female subject, 18 years or older. * Any elective cardiac surgery
Exclusion criteria
* Subjects with impaired liver function defined as an elevated level of ALT and AST over 100 U/L. * Hyperhydration states (e.g. pulmonary edema, congestive heart failure). * Renal failure with creatinine blood levels \> 2.5 mg/dL or eGFR \< 30 ml/min (calculated using the DMRD formula). * Oliguria (UO\<0.5ml\\kg\\hr) or anuria (not related to hypovolemia) more than 12 hours. * Current Intracranial hemorrhage. * Current, hard to balance hyperkalemia. * Severe hypernatremia or severe hyperchloremia. * Known hypersensitivity to hydroxyethyl starch or to any of the excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chest tube drainage volume | Total volume at the time of removal of drains (48 hours after surgery on average) |
Secondary
| Measure | Time frame |
|---|---|
| 30-days all cause mortality | 30 days from surgery |
| Volume of replacement fluids given after surgery at each group | Summary of volume replacement at the time of discharge from ICU (48 hours after surgery on average) |
| In hospital - all cause mortality | End of hospitalization (5 days postsurgery on average) |
| Incidence of coagulopathy as defined by prolonged PT\PTT and abnormal thromboelastogram not due to clotting inhibitors during hospitalization. | Duration of hospitalization after surgery (expected average duration of 5 days) |
| Volume of Transfused blood products during hospitalization postsurgery | Duration of hospitalization after surgery (expected average duration of 5 days) |
| Incidence of kidney injury as defined by RIFLE criteria | Duration of hospitalization after surgery (expected average duration of 5 days) |
Countries
Israel
Contacts
Primary ContactLiran Shani, MD
Outcome results
None listed