Clinical trial · Interventional
A Pilot Study of Renal Hypothermia During Partial Nephrectomy
NCT00888641CI-TRIAL-00004982completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Renal hypothermia may preserve renal function in patients who require partial nephrectomy. In preparation for a definitive randomized controlled trial this pilot study will assess feasibility and variance data to be used for sample size estimation
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Neoplasm | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypothermia | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Normothermia
- description
- After arterial clamping, no ice slush will be used
- type
- EXPERIMENTAL
- label
- Hypothermia
- description
- After arterial clamping, the kidney will be surrounded in ice slush for 10 minutes
- interventionNames
- Procedure: Hypothermia
Primary outcomes (1)
- measure
- measures of renal function uCrCl be performed for estimation of renal function
- timeFrame
- 3 months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients presenting with a renal mass deemed amenable to an open partial nephrectomy regardless of stage or histology. 2. Bilateral renal function on radiographic imaging. 3. Willing to consent to randomization. 4. Willing to comply with study protocol. Exclusion Criteria: 1. Anatomically or functionally solitary kidney 2. Multiple renal tumours 3. Bilateral renal tumours 4. Life expectancy \< 3 months as deemed by treating physician 5. Age less than 18 years old 6. Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.