Renal ImpairmentNCT01529658
Renal Hypothermia During Partial Nephrectomy
A study testing Renal hypothermia in people with Renal Impairment and Kidney Diseases, run by Ottawa Hospital Research Institute at 6 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Impairment, Kidney Diseases, Urologic Diseases
- What is being tested?
- Renal hypothermia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 6 sitesCanada
- Study dates
- Sep 2012to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Capital Disctrict Health Authority
Halifax, Nova Scotia, B3H 1V7
St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6
London Health Science Centre
London, Ontario, N6C 2R5
The Ottawa Hospital
Ottawa, Ontario, K1y 4E9
Centre hospitalier universitaire de Québec
Québec, Quebec, G1R 2J7
University Health Network
Toronto, Ontario, M5G 2N2
About this study
Official title: A Randomized Controlled Trial of Renal Hypothermia During Partial Nephrectomy
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.
Read more
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.
Read the detailed description
The incidence of renal cell carcinoma is increasing and in 2008 it is estimated that over 51,000 new renal cancers will be diagnosed in the United States. To preserve renal function, urologists commonly remove the diseased segment of the kidney (partial nephrectomy) instead of removing the entire kidney (radical nephrectomy). While the benefit of preserving function in patients with renal cell carcinoma has become clear, optimal preservation techniques are yet to be determined. Specifically, the role of hypothermia during partial nephrectomy has been inadequately studied despite theoretical benefit. The investigators objective is to assess the effectiveness of renal hypothermia during partial nephrectomy. The investigators hypothesis is that renal hypothermia during partial nephrectomy results in improved post-operative renal function compared to warm ischemia.
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
- Renal Impairment, Kidney Diseases, Urologic Diseases, Cancer, Hypothermia, Kidney Cancer
- Being tested
- Renal hypothermia
- Keywords
- Renal function, Renal hypothermia, Nephrology, Nephrectomy, Renal tumor, Urology, Kidney
- Medical subject headings
- Renal Insufficiency, Kidney Diseases, Urologic Diseases, Neoplasms, Hypothermia, Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal hypothermiaProcedure or surgery
Also called Ice
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.
| Study group | Role | What they receive |
|---|---|---|
| No hypothermia | No intervention | After clamping of the renal vessels, no ice slush will be used. |
| Hypothermia | Experimental | saline ice slush around kidney for 10 minutes. Receives: Procedure: Renal hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function
Glomerular filtration rate will be measured using the plasma clearance of 99mTc-DTPA.
Measured: 12 months
Secondary outcomes (1)
Difference in affected renal function
Side-specific renal function will be calculated by the product of overall glomerular filtration (determined from 99mTc-DTPA plasma clearance) and relative renal contribution (determined from 99mTc-DTPA renal scintigraphy).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Ilias Cagiannos, MD, Principal investigator, The Ottawa Hospital, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529658
- Sponsor's protocol ID
- 2010-767; CIHR MOP 269009
- Status last verified
- Oct 2016
- First submitted
- 6 Feb 2012
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30610026
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Renal Hypothermia During Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT01529658
- Acronym / sponsor ID
- 2010-767; CIHR MOP 269009
- Conditions
- Renal Impairment, Kidney Diseases, Urologic Diseases, Cancer, Hypothermia, Kidney Cancer
- Keywords
- Renal function, Renal hypothermia, Nephrology, Nephrectomy, Renal tumor, Urology, Kidney
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2012
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 9 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The incidence of renal cell carcinoma is increasing and in 2008 it is estimated that over 51,000 new renal cancers will be diagnosed in the United States. To preserve renal function, urologists commonly remove the diseased segment of the kidney (partial nephrectomy) instead of removing the entire kidney (radical nephrectomy). While the benefit of preserving function in patients with renal cell carcinoma has become clear, optimal preservation techniques are yet to be determined. Specifically, the role of hypothermia during partial nephrectomy has been inadequately studied despite theoretical benefit. The investigators objective is to assess the effectiveness of renal hypothermia during partial nephrectomy. The investigators hypothesis is that renal hypothermia during partial nephrectomy results in improved post-operative renal function compared to warm ischemia.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No hypothermia | No intervention | –After clamping of the renal vessels, no ice slush will be used. |
| Hypothermia | Experimental | Procedure: Renal hypothermiasaline ice slush around kidney for 10 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal hypothermiaAlso: IceWithin 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. | Procedure or surgery | Hypothermia |
Primary outcome
Renal function
Time frame: 12 months
Glomerular filtration rate will be measured using the plasma clearance of 99mTc-DTPA.
1 secondary outcome
Difference in affected renal function
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Derived from this study: PubMed 30610026Breau 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilias Cagiannos, MD principal investigator
The Ottawa Hospital, Ottawa Hospital Research Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal hypothermia in people with Renal Impairment and Kidney Diseases, run by Ottawa Hospital Research Institute at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01529658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.