Renal Hypothermia During Partial Nephrectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Ottawa Hospital Research Institute
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01529658
First received: February 6, 2012
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Renal Impairment
Kidney Diseases
Urologic Diseases
Cancer
Hypothermia
Kidney Cancer
Procedure: Renal hypothermia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Renal Hypothermia During Partial Nephrectomy

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Renal function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Glomerular filtration rate will be measured using the plasma clearance of 99mTc-DTPA.


Secondary Outcome Measures:
  • Difference in affected renal function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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-DMSA renal scintigraphy).


Estimated Enrollment: 180
Study Start Date: September 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No hypothermia
After clamping of the renal vessels, no ice slush will be used.
Experimental: Hypothermia
After clamping of the renal vessels, the kidney will be surrounded in ice slush for 10 minutes.
Procedure: 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 Name: Ice

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529658

Contacts
Contact: Ilias Cagiannos, MD 613-761-4500 ext 14500 icagiannos@ottawahospital.on.ca
Contact: Louise LeBel, B.Sc.N. 613-737-8899 ext 74639 llebel@ohri.ca

Locations
United States, Minnesota
The Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Bradley Leibovich, MD         
Canada, Nova Scotia
Capital Disctrict Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Ricardo Rendon, MD    902-425-3940    rrendon@dal.ca   
Canada, Ontario
St. Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Principal Investigator: Anil Kapoor, MD         
London Health Science Centre Recruiting
London, Ontario, Canada, N6C 2R5
Principal Investigator: Jonathan Izawa, MD         
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1y 4E9
Principal Investigator: Ilias Cagianno, MD         
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2N2
Principal Investigator: Michael Jewett, MD         
Canada, Quebec
Centre hospitalier universitaire de Québec Recruiting
Québec, Quebec, Canada, G1R 2J7
Principal Investigator: Frederic Pouliot, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Ilias Cagiannos, MD The Ottawa Hospital, Ottawa Hospital Research Institute
  More Information

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01529658     History of Changes
Other Study ID Numbers: 2010-767; CIHR MOP 269009
Study First Received: February 6, 2012
Last Updated: February 7, 2014
Health Authority: Canada: Ethics Review Committee
United States: Institutional Review Board

Keywords provided by Ottawa Hospital Research Institute:
Renal function
Renal hypothermia
Nephrology
Nephrectomy
Renal tumor
Urology
Kidney

Additional relevant MeSH terms:
Kidney Diseases
Hypothermia
Renal Insufficiency
Carcinoma, Renal Cell
Kidney Neoplasms
Urologic Diseases
Body Temperature Changes
Signs and Symptoms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 01, 2014