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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2020-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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HES 130/0.4 (Voluven)

6% HES 130/0.4 during surgery

Group Type EXPERIMENTAL

HES 130/0.4 (Voluven)

Intervention Type DRUG

human albumin 5%

human albumin 5% during surgery

Group Type ACTIVE_COMPARATOR

human albumin 5%

Intervention Type DRUG

Interventions

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human albumin 5%

Intervention Type DRUG

HES 130/0.4 (Voluven)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No