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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ringer-albumin | Active Comparator | Patients receiving the standard care of ringer-albumin as volume replacement after cardiac surgery |
|
| Tetraspan | Experimental | patients receiving a 3rd generation HES solution (tetraspan) for volume replacement after cardiac surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balanced hydroxyethyl starch solution | Drug | Patients receiving Tetraspan 6% ( a balanced 3rd generation Hydroxyethyl starch)for volume replacement after elective cardiac surgery as needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Chest tube drainage volume | Total volume at the time of removal of drains (48 hours after surgery on average) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liran Shani, MD | Contact | 972-8542631 | l_shani@rambam.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Zvi Adler, MD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam health care campus | Haifa | Israel |
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| ID | Term |
|---|---|
| D000075462 | Serum Albumin, Human |
| ID | Term |
|---|---|
| D012709 | Serum Albumin |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| Ringer- albumin | Drug | Patients receiving lactated ringer-albumin solution for volume replacement after cardiac surgery |
|
|
| 30-days all cause mortality | 30 days from surgery |
| Incidence of kidney injury as defined by RIFLE criteria | Duration of hospitalization after surgery (expected average duration of 5 days) |
| 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) |
| D001798 |
| Blood Proteins |