Use of 6% Hydroxyethylstarch (130/0.4) in Cardiac Surgical Patients (SHARP)

NeuroTherapia, Inc.

Status and phase

Completed

Phase 3

Conditions

Postoperative Kidney Injury

Treatments

Drug: human albumin 5%

Drug: HES 130/0.4 (Voluven)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02192502

012-973

Details and patient eligibility

About

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.

Enrollment

149 patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 50 - 85 years old
Scheduled for elective aortic valve replacement with or without coronary artery bypass grafting with or without additional minor surgical procedure.
Written, informed consent for participation in this investigation.

Exclusion criteria

Patients with renal failure with oliguria or anuria not related to hypovolemia.
Patients receiving dialysis.
Patients with preoperative renal insufficiency (Creatinine > 1.6 mg/dL)
Anticipated deep hypothermic circulatory arrest
Known hypersensitivity or allergy to hydroxyethyl starch or the excipients of hydroxyethyl starch
Clinical conditions with volume overload (e.g., patients in pulmonary edema or congestive heart failure)
Patients with severe hypernatremia or severe hyperchloremia
Patients with intracranial bleeding
Pregnant or breast feeding women
Critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy, (e.g. patients who are hospitalized in the intensive care unit prior to surgery)
Severe liver disease
Pre-existing coagulation or bleeding disorders
Any contraindications to proposed interventions.