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

NCT02192502 | Completed Phase 3 Results DMC

• 1 other identifier: 012-973
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) [Time Frame: 24 Hours After Surgery] [Designated as Safety Issue: Yes]

  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), at one hour of arrival to intensive care unit (ICU), at 24 hours following completion of surgery.

  3 measurements in total from baseline to 24 hours after surgery: the first one is at baseline; the second one is at one hour of arrive to ICU and last one is at 24 hours after surgery

Secondary Outcomes (3)

• Kidney Function

  within first 7 postoperative days

• Postop Urine IL-18

  postoperative 1 hour

• Postop Urine IL-18

  24 hours after surgery

Study Arms (2)

HES 130/0.4 (Voluven)

EXPERIMENTAL

6% HES 130/0.4 during surgery

Drug: HES 130/0.4 (Voluven)

human albumin 5%

ACTIVE COMPARATOR

human albumin 5% during surgery

Drug: human albumin 5%

Interventions

human albumin 5% DRUG

human albumin 5%

HES 130/0.4 (Voluven) DRUG

HES 130/0.4 (Voluven)

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Fresenius Kabi: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (3)

• Lee MJ, Tannenbaum C, Mao G, Jia Y, Leung S, Yilmaz HO, Ince I, Soltesz E, Duncan AE. Effect of 6% Hydroxyethyl Starch 130/0.4 on Inflammatory Response and Pulmonary Function in Patients Having Cardiac Surgery: A Randomized Clinical Trial. Anesth Analg. 2021 Oct 1;133(4):906-914. doi: 10.1213/ANE.0000000000005664.

  PMID: 34406128 DERIVED

• Katabi LJ, Pu X, Yilmaz HO, Jia Y, Leung S, Duncan AE. Prognostic Utility of KDIGO Urine Output Criteria After Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Oct;35(10):2991-3000. doi: 10.1053/j.jvca.2021.02.027. Epub 2021 Feb 13.

  PMID: 33744114 DERIVED

• Duncan AE, Jia Y, Soltesz E, Leung S, Yilmaz HO, Mao G, Timur AA, Kottke-Marchant K, Rogers HJ, Ma C, Ince I, Karimi N, Yagar S, Trombetta C, Sessler DI. Effect of 6% hydroxyethyl starch 130/0.4 on kidney and haemostatic function in cardiac surgical patients: a randomised controlled trial. Anaesthesia. 2020 Sep;75(9):1180-1190. doi: 10.1111/anae.14994. Epub 2020 Feb 18.

  PMID: 32072617 DERIVED

MeSH Terms

Interventions

Hydroxyethyl Starch Derivatives; HES 130-0.4

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides

Results Point of Contact

• Title: Dr. Andra Duncan
• Organization: Cleveland Clinic

duncana@ccf.org

216-538-6944

Study Officials

• Andra Duncan, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 16, 2014
• Study Start: March 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2020
• Last Updated: February 14, 2023
• Results First Posted: February 14, 2023

Record last verified: 2023-02

Locations

US (1)