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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02192502
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : April 20, 2022
Sponsor:
Collaborator:
Fresenius Kabi
Information provided by (Responsible Party):
The Cleveland Clinic

Brief 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.


Condition or disease Intervention/treatment Phase
Postoperative Kidney Injury Drug: human albumin 5% Drug: HES 130/0.4 (Voluven) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Investigation of the Effects of 6% Hydroxyethylstarch 130/0.4 (Voluven) on Renal Function in Patients Having Aortic Valve Replacement With or Without Coronary Artery Bypass Grafting
Actual Study Start Date : March 2015
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HES 130/0.4 (Voluven)
6% HES 130/0.4 during surgery
Drug: HES 130/0.4 (Voluven)
Active Comparator: human albumin 5%
human albumin 5% during surgery
Drug: human albumin 5%



Primary Outcome Measures :
  1. Urine neutrophil gelatinase-associated lipocalin (NGAL) [Time Frame: 24 hours after surgery] [Designated as safety issue: Yes] [ Time Frame: 24 hours after surgery ]
    To assess the safety of HES 130/0.4 (Voluven) versus albumin 5% on renal function we will measure urinary concentrations of neutrophil gelatinase-associated lipocalin (NGAL), an important marker of renal function, measured at baseline (following anesthetic induction and prior to surgical incision), within one hour of arrival to intensive care unit (ICU), and 24 hours following completion of surgery compared with baseline.


Secondary Outcome Measures :
  1. coagulation parameters and measures of platelet aggregation [ Time Frame: 24 hours after surgery ]
    Kidney function; urine interleukin-18 [Time frame: 24 hours after surgery]. To assess the safety of HES 130/0.4 (Voluven) on additional measures of renal function, we measure urinary concentrations of interleukin (IL)- 18 at baseline (following anesthetic induction and prior to surgical incision), within one hour of arrival to ICU, and 24 hours following completion of surgery. We will also measure daily serum creatinine and need for renal replacement therapy platelet function and coagulation [Time Frame: 24 hours following completion of surgery] [ Designated as safety issues: Yes] To assess the safety of HES 130/0.4 versus albumin 5% as measured by coagulation parameters and Platelet function measured at baseline, within one hour of arrival to ICU, and 24 hours following surgery as well as clinical outcomes including coagulation paramenters and measures of platelet aggregation.



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192502


Locations
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United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Fresenius Kabi
Investigators
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Principal Investigator: Andra Duncan, M.D. The Cleveland Clinic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02192502    
Other Study ID Numbers: 012-973
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: April 20, 2022
Last Verified: April 2022