Kidney NeoplasmPhase 1NCT00888641
A Pilot Study of Renal Hypothermia During Partial Nephrectomy
A Phase 1 study testing Hypothermia in people with Kidney Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Neoplasm
- What is being tested?
- Hypothermia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to May 2011
- Phase
- Phase 1
- 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 or histology.
- Bilateral renal function on radiographic imaging.
- Willing to consent to randomization.
- Willing to comply with study protocol.
Who cannot join
- Anatomically or functionally solitary kidney
- Multiple renal tumours
- Bilateral renal tumours
- Life expectancy < 3 months as deemed by treating physician
- Age less than 18 years old
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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
- Kidney Neoplasm
- Being tested
- Hypothermia
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypothermiaProcedure or surgery
Surround kidney in ice slush for 10 minutes after arterial clamping
| Study group | Role | What they receive |
|---|---|---|
| Normothermia | No intervention | After arterial clamping, no ice slush will be used |
| Hypothermia | Experimental | After arterial clamping, the kidney will be surrounded in ice slush for 10 minutes Receives: Procedure: Hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
measures of renal function uCrCl be performed for estimation of renal function
Measured: 3 months
Secondary outcomes (1)
Post-operative complication
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888641
- Sponsor's protocol ID
- 08-007979
- Status last verified
- Jun 2011
- First submitted
- 24 Apr 2009
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Renal Hypothermia During Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT00888641
- Acronym / sponsor ID
- 08-007979
- Conditions
- Kidney Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 27 Apr 2009 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normothermia | No intervention | –After arterial clamping, no ice slush will be used |
| Hypothermia | Experimental | Procedure: HypothermiaAfter arterial clamping, the kidney will be surrounded in ice slush 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 (4 listed)
- Patients presenting with a renal mass deemed amenable to an open partial nephrectomy regardless of stage or histology.
- Bilateral renal function on radiographic imaging.
- Willing to consent to randomization.
- Willing to comply with study protocol.
Key exclusion criteria (6 listed)
- Anatomically or functionally solitary kidney
- Multiple renal tumours
- Bilateral renal tumours
- Life expectancy < 3 months as deemed by treating physician
- Age less than 18 years old
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 |
|---|---|---|
| HypothermiaSurround kidney in ice slush for 10 minutes after arterial clamping | Procedure or surgery | Hypothermia |
Primary outcome
measures of renal function uCrCl be performed for estimation of renal function
Time frame: 3 months
1 secondary outcome
Post-operative complication
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hypothermia in people with Kidney Neoplasm, run by Mayo Clinic at 1 site in United States.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
measures of renal function uCrCl be performed for estimation of renal function (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2011.