Trial · NCT02361736
Evaluate the Nephrotoxicity by 6% Hydroxyethyl Starch 130/0.4 in Old Patients During Orthopaedic Surgery
NCT02361736, Not applicable, Completed, Yuanyuan Zhang; results first posted 2016-03-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluate the Nephrotoxicity by 6% Hydroxyethyl Starch 130/0.4 in Old Patients During Orthopaedic Surgery. Trials, record NCT02361736. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02361736
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate the Nephrotoxicity by 6% Hydroxyethyl Starch 130/0.4 in Old Patients During Orthopaedic Surgery
- NCT number
- NCT02361736
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 120 participants, actual
- Lead sponsor
- Yuanyuan Zhang
- Conditions
- Total Fluid Volume Increased
- Interventions
- Hydroxyethyl Starch, Lactate Ringers
- First posted
- 2015-02-12
- Last updated
- 2016-03-24
- Results first posted
- 2016-03-24
- Limitations and caveats
- We may have to prolong the follow-up visit for patients.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Concentration of NGAL in Urine on 5 Time Point | -1d, 0d, 1d, 3d, 5d after surgery | Neutrophil gelatinase-associated lipocalin (NGAL) is a small protein, which is filtered via the glomeruli and reabsorbed in the proximal tubules, and thus low concentrations of NGAL can be measured in the blood and urine. |
| Primary | Concentration of IL-18 in Urine on 5 Time Point | -1d, 0d, 1d, 3d, 5d after surgery | IL-18 is mainly created from proximal kidney tubules which is a proinflammatory factor that can be detected in earlier urine of AKI animal models. |
| Primary | Concentration of IL-18 in Plasma on 5 Time Point | -1d, 0d, 1d, 3d, 5d after surgery | |
| Primary | Concentration of NGAL in Plasma on 5 Time Point. | -1d, 0d, 1d, 3d, 5d after surgery | concentration of NGAL in plasma on 5 time point. Biomarkers are measured by ELISA. |
| Secondary | Concentration of β2 Microglobulin in Urine | -1d, 0d, 1d, 3d, 5d after surgery | |
| Secondary | Estimated Glomerular Filtration Rate(eGFR) on 5 Time Point | -1d, 0d, 1d, 3d, 5d after surgery | eGFR is calculated by concentration of creatinine and CKD-EPI2009 |
| Secondary | Ratio of the Urine Trace Albumin and Creatinine(ACR) on 5 Time Point | -1d, 0d, 1d, 3d, 5d after surgery | ACR is calculated by the urine trace albumin divided by the urine creatinine |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Concentration of NGAL in Urine on 5 Time Point | -1d, 0d, 1d, 3d, 5d after surgery | ng/ml | MEAN | |
| PRIMARY | Concentration of IL-18 in Urine on 5 Time Point | -1d, 0d, 1d, 3d, 5d after surgery | μg/L | MEAN | |
| PRIMARY | Concentration of IL-18 in Plasma on 5 Time Point | -1d, 0d, 1d, 3d, 5d after surgery | μg/L | MEAN | |
| SECONDARY | Concentration of β2 Microglobulin in Urine | -1d, 0d, 1d, 3d, 5d after surgery | mg/L | MEAN | |
| SECONDARY | Estimated Glomerular Filtration Rate(eGFR) on 5 Time Point | -1d, 0d, 1d, 3d, 5d after surgery | mL/min/1.73m2 | MEAN | |
| PRIMARY | Concentration of NGAL in Plasma on 5 Time Point. | -1d, 0d, 1d, 3d, 5d after surgery | ng/ml | MEAN | |
| SECONDARY | Ratio of the Urine Trace Albumin and Creatinine(ACR) on 5 Time Point | -1d, 0d, 1d, 3d, 5d after surgery | ratio | MEAN |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Concentration of NGAL in Urine on 5 Time Point | Lactate Ringers | -1d | 5.6 | Standard Deviation 0.7 | ng/ml |
| Concentration of NGAL in Urine on 5 Time Point | Hydroxyethyl Starch | -1d | 4.9 | Standard Deviation 0.8 | ng/ml |
| Concentration of NGAL in Urine on 5 Time Point | Lactate Ringers | 0d | 5.2 | Standard Deviation 0.4 | ng/ml |
| Concentration of NGAL in Urine on 5 Time Point | Hydroxyethyl Starch | 0d | 5.1 | Standard Deviation 0.3 | ng/ml |
| Concentration of NGAL in Urine on 5 Time Point | Lactate Ringers | 1d | 4.9 | Standard Deviation 0.3 | ng/ml |
| Concentration of NGAL in Urine on 5 Time Point | Hydroxyethyl Starch | 1d | 4.9 | Standard Deviation 0.4 | ng/ml |
| Concentration of NGAL in Urine on 5 Time Point | Lactate Ringers | 3d | 5.0 | Standard Deviation 0.3 | ng/ml |
| Concentration of NGAL in Urine on 5 Time Point | Hydroxyethyl Starch | 3d | 5.2 | Standard Deviation 0.5 | ng/ml |
| Concentration of NGAL in Urine on 5 Time Point | Lactate Ringers | 5d | 4.3 | Standard Deviation 0.8 | ng/ml |
| Concentration of NGAL in Urine on 5 Time Point | Hydroxyethyl Starch | 5d | 5.1 | Standard Deviation 0.4 | ng/ml |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lactate Ringers | 60 | |
| Overall Study | STARTED | Hydroxyethyl Starch | 60 | |
| Overall Study | COMPLETED | Lactate Ringers | 59 | |
| Overall Study | COMPLETED | Hydroxyethyl Starch | 59 | |
| Overall Study | NOT COMPLETED | Lactate Ringers | 1 | |
| Overall Study | NOT COMPLETED | Hydroxyethyl Starch | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lactate Ringers | ||
| Total, all-cause mortality | Hydroxyethyl Starch | ||
| Total, other adverse events | Lactate Ringers | 0 | 59 |
| Total, other adverse events | Hydroxyethyl Starch | 0 | 59 |
| Total, serious adverse events | Lactate Ringers | 0 | 59 |
| Total, serious adverse events | Hydroxyethyl Starch | 0 | 59 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28222674 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Lactate Ringers vs Hydroxyethyl Starch: serious adverse events |
Source 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/NCT02361736
GET https://conductscience.org/api/trials/v1/NCT02361736/results?page=2