Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
184 participants
INTERVENTIONAL
2012-09-30
2017-09-30
Brief Summary
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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.
Detailed Description
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Methods: To test the investigators hypothesis, 180 partial nephrectomy patients will be randomized to cold or warm ischemia. Global and side-specific renal function will be assessed pre-operatively and 12 months post-operatively using radionucleotide clearance and renal scintigraphy.
Significance: To the investigators knowledge, this study will be the first prospective trial to evaluate the clinical impact of renal hypothermia during partial nephrectomy. Since renal function preservation is the primary purpose of partial nephrectomy, these findings will have an important impact on surgical technique and patient outcome.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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No hypothermia
After clamping of the renal vessels, no ice slush will be used.
No interventions assigned to this group
Hypothermia
saline ice slush around kidney for 10 minutes.
Renal hypothermia
Within 10 seconds of clamping the renal vessels, the kidney will be encased with saline ice slush for a period of 10 minutes. The slush will be created from sterile saline using an operating room slush machine. The slush is applied by the surgeon and lightly packed around the kidney to ensure complete coverage with at least a 2 cm layer. Slush removal is performed by the surgeon beginning at the 10 minute mark. Enough slush is removed to uncover the tumour area. Surgical incision of the kidney begins as soon as the tumour area is uncovered.
When reconstruction of the kidney is complete, the slush is completely removed from the surgical field and the clamps are removed from the renal vein and artery.
Interventions
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Renal hypothermia
Within 10 seconds of clamping the renal vessels, the kidney will be encased with saline ice slush for a period of 10 minutes. The slush will be created from sterile saline using an operating room slush machine. The slush is applied by the surgeon and lightly packed around the kidney to ensure complete coverage with at least a 2 cm layer. Slush removal is performed by the surgeon beginning at the 10 minute mark. Enough slush is removed to uncover the tumour area. Surgical incision of the kidney begins as soon as the tumour area is uncovered.
When reconstruction of the kidney is complete, the slush is completely removed from the surgical field and the clamps are removed from the renal vein and artery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing to consent to randomization
* Willing to comply with study protocol
Exclusion Criteria
* Life expectancy \< 3 months as deemed by treating physician
* Age less than 18 years old
* Pregnancy
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Ilias Cagiannos, MD
Role: PRINCIPAL_INVESTIGATOR
The Ottawa Hospital, Ottawa Hospital Research Institute
Locations
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Capital Disctrict Health Authority
Halifax, Nova Scotia, Canada
St. Joseph's Healthcare
Hamilton, Ontario, Canada
London Health Science Centre
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Centre hospitalier universitaire de Québec
Québec, Quebec, Canada
Countries
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References
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Breau 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.
Other Identifiers
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2010-767; CIHR MOP 269009
Identifier Type: -
Identifier Source: org_study_id