Use of 6% Hydroxyethylstarch (130/0.4) in Cardiac Surgical Patients
Condition: Postoperative Kidney Injury
Intervention: human albumin 5%; HES 130/0.4 (Voluven)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 149.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.