Clinical trial · Interventional
Renal Hypothermia During Partial Nephrectomy
A Randomized Controlled Trial of Renal Hypothermia During Partial Nephrectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The Objective is to determine if renal hypothermia during open partial nephrectomy results in improved post-operative renal function compared to warm ischemia. Primary Aim is to determine the effect of hypothermia on preservation of overall renal function compared to no hypothermia in patients who require hilar vessel clamping during open partial nephrectomy for a renal tumor. Hypothesis: Hypothermia will result in improved post-operative preservation of overall renal function. Secondary Aim is to determine the effect of hypothermia on preservation of affected renal function (kidney with the tumor) compared to no hypothermia in patients who require hilar vessel clamping during open partial nephrectomy for a renal tumor. Hypothesis: Hypothermia will result in improved post-operative preservation of affected renal function.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Hypothermia | — | UNRESOLVED | — |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Kidney Diseases | — | UNRESOLVED | — |
| Renal Impairment | — | UNRESOLVED | — |
| Urologic Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Renal hypothermia | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- No hypothermia
- description
- After clamping of the renal vessels, no ice slush will be used.
- type
- EXPERIMENTAL
- label
- Hypothermia
- description
- saline ice slush around kidney for 10 minutes.
- interventionNames
- Procedure: Renal hypothermia
Primary outcomes (1)
- measure
- Renal function
- timeFrame
- 12 months
- description
- Glomerular filtration rate will be measured using the plasma clearance of 99mTc-DTPA.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients presenting with a renal mass deemed amenable to an open partial nephrectomy regardless of stage, histology, presence of solitary kidney, multiple tumors or renal function. Participating surgeons will identify patients they consider to be appropriate candidates for partial nephrectomy with or without renal hypothermia. * Willing to consent to randomization * Willing to comply with study protocol Exclusion Criteria: * Bilateral renal tumours with planned surgery either partial or radical nephrectomy on the contralateral kidney within the 12 months of the study. * Life expectancy \< 3 months as deemed by treating physician * Age less than 18 years old * Pregnancy
References
Publications (1)
- DERIVEDBreau RH, Cagiannos I, Knoll G, Morash C, Cnossen S, Lavallee LT, Mallick R, Finelli A, Jewett M, Leibovich BC, Cook J, LeBel L, Kapoor A, Pouliot F, Izawa J, Rendon R, Fergusson DA. Renal hypothermia during partial nephrectomy for patients with renal tumours: a randomised controlled clinical trial protocol. BMJ Open. 2019 Jan 3;9(1):e025662. doi: 10.1136/bmjopen-2018-025662. PMID 30610026