Postoperative Kidney InjuryPhase 3SHARPNCT02192502
Use of 6% Hydroxyethylstarch (130/0.4) in Cardiac Surgical Patients
A Phase 3 study testing human albumin 5% and HES 130/0.4 (Voluven) in people with Postoperative Kidney Injury, run by The Cleveland Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Postoperative Kidney Injury
- What is being tested?
- human albumin 5% and HES 130/0.4 (Voluven)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Feb 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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
- Being tested
- human albumin 5%, HES 130/0.4 (Voluven)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human albumin 5%Drug
HES 130/0.4 (Voluven)Drug
| Study group | Role | What they receive |
|---|---|---|
| HES 130/0.4 (Voluven) | Experimental | 6% HES 130/0.4 during surgery Receives: Drug: HES 130/0.4 (Voluven) |
| human albumin 5% | Active comparator | human albumin 5% during surgery Receives: Drug: human albumin 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Postoperative kidney dysfunction using RIFLE diagnostic criteria was also assessed. Patients were assessed for risk for kidney dysfunction (RIFLE-R), injury to the kidney (RIFLE-I), failure of kidney function (RIFLE-F) using criteria based on only peak serum creatinine concentrations within the first seven postoperative days. Due to too few events, this outcome was redefined to risk (or worse) vs. no risk for this analysis.
RIFLE classification criteria is listed below:
Risk (RIFLE-R) Increase in serum creatinine x 1.5 from baseline Injury (RIFLE-I) Increase in serum creatinine x 2 from baseline Failure (RIFLE-F) Increase in serum creatinine x 3 from baseline Loss (RIFLE-L) Complete loss of kidney function > 4 weeks End stage (RIFLE-E) End-stage kidney failure > 3 months
Measured: within first 7 postoperative days
Postop Urine IL-18
Postop Urine IL-18 (interleukin-18) measured at 1 h of arrival to ICU
Measured: postoperative 1 hour
Postop Urine IL-18
Postoperative urine IL-18 (interleukin-18) measured at 24 hours after surgery
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startMar 2015
- Primary completionFeb 2018
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Kidney InjuryStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Kabi
- Responsible party
- Sponsor
- Investigators
- Andra Duncan, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192502
- Sponsor's protocol ID
- 012-973
- Acronym
- SHARP
- Status last verified
- Feb 2023
- First submitted
- 15 Jul 2014
- Last updated
- 14 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 34406128Katabi 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.
PubMed 33744114Duncan 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.
PubMed 32072617
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02192502
- Acronym / sponsor ID
- SHARP / 012-973
- Conditions
- Postoperative Kidney Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Fresenius Kabi
- Study start
- Mar 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Posted 14 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HES 130/0.4 (Voluven) | Experimental | Drug: HES 130/0.4 (Voluven)6% HES 130/0.4 during surgery |
| human albumin 5% | Active comparator | Drug: human albumin 5%human albumin 5% during surgery |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human albumin 5% | Drug | human albumin 5% |
| HES 130/0.4 (Voluven) | Drug | HES 130/0.4 (Voluven) |
Primary outcome
Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) [Time Frame: 24 Hours After Surgery] [Designated as Safety Issue: Yes]
Time frame: 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
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 secondary outcomes
Kidney Function
Time frame: within first 7 postoperative days
Postop Urine IL-18
Time frame: postoperative 1 hour
Postop Urine IL-18
Time frame: 24 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34406128Lee 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.
- Derived from this study: PubMed 33744114Katabi 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.
- Derived from this study: PubMed 32072617Duncan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andra Duncan, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing human albumin 5% and HES 130/0.4 (Voluven) in people with Postoperative Kidney Injury, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) [Time Frame: 24 Hours After Surgery] [Designated as Safety Issue: Yes] (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02192502, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.