Use of 6% Hydroxyethylstarch (130/0.4) in Cardiac Surgical Patients
Status:
Active, not recruiting
Trial end date:
2021-10-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the safety of a standard volume replacement called
HES 130/0.4 (Voluven) during surgery on recovery. HES 130/0.4 (Voluven) may offer an
alternative to pure fluid replacement solutions that are associated with problems after
surgery including fluid overload and respiratory difficulties. The safety of HES 130/0.4
(Voluven) will be evaluated by examining its effects on kidney function, and coagulation
parameters and platelet (part of the blood that help it clot) function.
Participants will be randomized (like flipping a coin) to receive one of two possible volume
replacements during surgery, if fluid volume decreases enough to need replacement with one of
the fluids. The two possible volume replacements are Voluven (a starch-containing fluid) or
human albumin 5% (a protein-containing solution).
To examine kidney function, urine will be-sampled when the participant is put under general
anesthesia, before surgical incision, within one hour of arrival to the ICU and 24 hours
after completion of surgery. Two tubes (2 teaspoons) of blood (from an already established
line) will be taken the morning of the surgery, within one hour of arrival to the ICU, 24
hours after surgery and every morning during the participants postoperative ICU stay.
Additionally, health and recovery information will be recorded from the participant's medical
record. We will phone participants around 90 days and one year after surgery to ask a few
questions about one's health and recovery. We will also record blood sample analysis results
from follow up appointments within the first year after surgery. If this analysis is not
conducted at the Cleveland Clinic, with permission, we will obtain the results from a
treating physician.