Trial · NCT02192502
Use of 6% Hydroxyethylstarch (130/0.4) in Cardiac Surgical Patients
NCT02192502, Phase 3, Completed, The Cleveland Clinic; results first posted 2023-02-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Use of 6% Hydroxyethylstarch (130/0.4) in Cardiac Surgical Patients. Trials, record NCT02192502. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02192502
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of 6% Hydroxyethylstarch (130/0.4) in Cardiac Surgical Patients
- NCT number
- NCT02192502
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 149 participants, actual
- Lead sponsor
- The Cleveland Clinic
- Conditions
- Postoperative Kidney Injury
- Interventions
- human albumin 5%, HES 130/0.4 (Voluven)
- First posted
- 2014-07-16
- Last updated
- 2023-02-14
- Results first posted
- 2023-02-14
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) [Time Frame: 24 Hours After Surgery] [Designated as Safety Issue: Yes] | 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. |
| Secondary | Kidney Function | within first 7 postoperative days | 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 |
| Secondary | Postop Urine IL-18 | postoperative 1 hour | Postop Urine IL-18 (interleukin-18) measured at 1 h of arrival to ICU |
| Secondary | Postop Urine IL-18 | 24 hours after surgery | Postoperative urine IL-18 (interleukin-18) measured at 24 hours after surgery |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) [Time Frame: 24 Hours After Surgery] [Designated as Safety Issue: Yes] | 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 | ng/ml | MEDIAN | |
| SECONDARY | Kidney Function | within first 7 postoperative days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Postop Urine IL-18 | postoperative 1 hour | pg/ml | MEDIAN | |
| SECONDARY | Postop Urine IL-18 | 24 hours after surgery | pg/ml | MEDIAN | |
| POST_HOC | Kidney Function | within the first seven postoperative days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) [Time Frame: 24 Hours After Surgery] [Designated as Safety Issue: Yes] | HES 130/0.4 (Voluven) | baseline | 2.9 | Inter-Quartile Range 1.8 to 5.4 | ng/ml |
| Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) [Time Frame: 24 Hours After Surgery] [Designated as Safety Issue: Yes] | Human Albumin 5% | baseline | 4.0 | Inter-Quartile Range 2.2 to 6.4 | ng/ml |
| Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) [Time Frame: 24 Hours After Surgery] [Designated as Safety Issue: Yes] | HES 130/0.4 (Voluven) | at 1 hour after surgery | 5.0 | Inter-Quartile Range 1.4 to 68 | ng/ml |
| Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) [Time Frame: 24 Hours After Surgery] [Designated as Safety Issue: Yes] | Human Albumin 5% | at 1 hour after surgery | 4.7 | Inter-Quartile Range 1.6 to 74 | ng/ml |
| Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) [Time Frame: 24 Hours After Surgery] [Designated as Safety Issue: Yes] | HES 130/0.4 (Voluven) | at 24 hours after surgery | 12 | Inter-Quartile Range 6.8 to 23 | ng/ml |
| Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) [Time Frame: 24 Hours After Surgery] [Designated as Safety Issue: Yes] | Human Albumin 5% | at 24 hours after surgery | 15 | Inter-Quartile Range 7.1 to 22 | ng/ml |
| Kidney Function | HES 130/0.4 (Voluven) | No risk | 61 | Participants | |
| Kidney Function | Human Albumin 5% | No risk | 69 | Participants | |
| Kidney Function | HES 130/0.4 (Voluven) | Risk | 5 | Participants | |
| Kidney Function | Human Albumin 5% | Risk | 2 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HES 130/0.4 (Voluven) | 76 | |
| Overall Study | STARTED | Human Albumin 5% | 73 | |
| Overall Study | COMPLETED | HES 130/0.4 (Voluven) | 69 | |
| Overall Study | COMPLETED | Human Albumin 5% | 72 | |
| Overall Study | NOT COMPLETED | HES 130/0.4 (Voluven) | 7 | |
| Overall Study | NOT COMPLETED | Human Albumin 5% | 1 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Thrombocytopenia | Blood and lymphatic system disorders | HES 130/0.4 (Voluven) | 2 | 69 | 2 |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Human Albumin 5% | 2 | 72 | 2 |
| serious | cardiac-related | Cardiac disorders | HES 130/0.4 (Voluven) | 13 | 69 | 15 |
| serious | cardiac-related | Cardiac disorders | Human Albumin 5% | 7 | 72 | 7 |
| serious | Injury | Injury, poisoning and procedural complications | HES 130/0.4 (Voluven) | 0 | 69 | 0 |
| serious | Injury | Injury, poisoning and procedural complications | Human Albumin 5% | 1 | 72 | 1 |
| serious | Nervous disorder | Nervous system disorders | HES 130/0.4 (Voluven) | 2 | 69 | 2 |
| serious | Nervous disorder | Nervous system disorders | Human Albumin 5% | 2 | 72 | 2 |
| serious | Urinary retention | Renal and urinary disorders | HES 130/0.4 (Voluven) | 0 | 69 | 0 |
| serious | Urinary retention | Renal and urinary disorders | Human Albumin 5% | 1 | 72 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HES 130/0.4 (Voluven) | 0 | 69 |
| Total, all-cause mortality | Human Albumin 5% | 2 | 72 |
| Total, other adverse events | HES 130/0.4 (Voluven) | 0 | 69 |
| Total, other adverse events | Human Albumin 5% | 0 | 72 |
| Total, serious adverse events | HES 130/0.4 (Voluven) | 17 | 69 |
| Total, serious adverse events | Human Albumin 5% | 12 | 72 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| HES 130/0.4 (Voluven) vs Human Albumin 5%: deaths from any cause | Trial comparisons |
| HES 130/0.4 (Voluven) vs Human Albumin 5%: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02192502
GET https://conductscience.org/api/trials/v1/NCT02192502/results?page=2