Trial · NCT01606787
Mannitol Use During Partial Nephrectomy Prior to Renal Ischemia and Impact on Renal Function Outcomes
NCT01606787, Phase 3, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2018-06-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mannitol Use During Partial Nephrectomy Prior to Renal Ischemia and Impact on Renal Function Outcomes. Trials, record NCT01606787. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01606787
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mannitol Use During Partial Nephrectomy Prior to Renal Ischemia and Impact on Renal Function Outcomes
- NCT number
- NCT01606787
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 210 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Renal Cancer
- Interventions
- mannitol, placebo
- First posted
- 2012-05-28
- Last updated
- 2018-10-15
- Results first posted
- 2018-06-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to 6 Months | 6 months | The difference will be assessed with an ANCOVA model with eGFR 6 months after surgery (+/- 2 months) as the outcome and treatment group, surgical technique, and preoperative eGFR as covariates. We will report a two-tailed p-value and a 95% confidence interval for the difference between groups. If a patient does not have an eGFR measurement between 5-7 months after surgery and has both a measurement between 3-5 months and 7-12 months after surgery, then the 6 month eGFR measurement will be linearly interpolated. |
| Secondary | Percent Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to 6 Weeks | 6 weeks | between treatment groups at 6 weeks (+/- 4 weeks) after surgery with postoperative eGFR as the outcome, and treatment group, surgical technique, and preoperative eGFR as covariates. We will also use the ANCOVA on the absolute level of eGFR because this has the greatest statistical power. However, the estimate produced by ANCOVA - a mean difference in eGFR levels - is of incomplete clinical interpretability. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to 6 Months | 6 months | % change from preoperative eGFR | MEAN | |
| SECONDARY | Percent Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to 6 Weeks | 6 weeks | % change from preoperative eGFR | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to 6 Months | Mannitol Arm | -8.5 | Standard Deviation 14 | % change from preoperative eGFR | |
| Percent Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to 6 Months | Placebo Arm | -8.4 | Standard Deviation 12 | % change from preoperative eGFR | |
| Percent Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to 6 Weeks | Mannitol Arm | -6.2 | Standard Deviation 13 | % change from preoperative eGFR | |
| Percent Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to 6 Weeks | Placebo Arm | -9.4 | Standard Deviation 14 | % change from preoperative eGFR |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mannitol Arm | 105 | |
| Overall Study | STARTED | Placebo Arm | 105 | |
| Overall Study | COMPLETED | Mannitol Arm | 101 | |
| Overall Study | COMPLETED | Placebo Arm | 98 | |
| Overall Study | NOT COMPLETED | Mannitol Arm | 4 | |
| Overall Study | NOT COMPLETED | Placebo Arm | 7 |
Source ClinicalTrials.gov
Adverse events50
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 |
|---|---|---|---|---|---|---|
| other | Urinary Fistula | Renal and urinary disorders | Mannitol Arm | 1 | 101 | |
| other | Urinary Fistula | Renal and urinary disorders | Placebo Arm | 1 | 98 | |
| other | Fever | General disorders | Mannitol Arm | 1 | 101 | |
| other | Fever | General disorders | Placebo Arm | 0 | 98 | |
| other | Pneumonitis | Respiratory, thoracic and mediastinal disorders | Mannitol Arm | 0 | 101 | |
| other | Pneumonitis | Respiratory, thoracic and mediastinal disorders | Placebo Arm | 1 | 98 | |
| other | Lung infection | Infections and infestations | Mannitol Arm | 0 | 101 | |
| other | Lung infection | Infections and infestations | Placebo Arm | 1 | 98 | |
| other | Injury/poison & proced complications Other, spec | Injury, poisoning and procedural complications | Mannitol Arm | 0 | 101 | |
| other | Injury/poison & proced complications Other, spec | Injury, poisoning and procedural complications | Placebo Arm | 1 | 98 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mannitol Arm | 0 | 101 |
| Total, all-cause mortality | Placebo Arm | 2 | 98 |
| Total, other adverse events | Mannitol Arm | 2 | 101 |
| Total, other adverse events | Placebo Arm | 7 | 98 |
| Total, serious adverse events | Mannitol Arm | 19 | 101 |
| Total, serious adverse events | Placebo Arm | 11 | 98 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28822586 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Mannitol Arm vs Placebo Arm: deaths from any cause | Trial comparisons |
| Mannitol Arm vs Placebo Arm: 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/NCT01606787
GET https://conductscience.org/api/trials/v1/NCT01606787/events?page=2