Renal Hypothermia During Partial Nephrectomy

NCT01529658 | Unknown DMC

• 1 other identifier: 2010-767; CIHR MOP 269009
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 6

Brief 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 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.

Conditions

Renal Impairment; Kidney Diseases; Urologic Diseases; Cancer; Hypothermia; Kidney Cancer

Keywords

Renal function; Renal hypothermia; Nephrology; Nephrectomy; Renal tumor; Urology; Kidney

Outcome Measures

Primary Outcomes (1)

• Renal function

  Glomerular filtration rate will be measured using the plasma clearance of 99mTc-DTPA.

  12 months

Secondary Outcomes (1)

• Difference in affected renal function

  12 months

Study Arms (2)

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.

Procedure: Renal hypothermia

Interventions

Renal hypothermia PROCEDURE

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.

Also known as: Ice

Hypothermia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (6)

Capital Disctrict Health Authority

Halifax, Nova Scotia, B3H 1V7, Canada

Location

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

London Health Science Centre

London, Ontario, N6C 2R5, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1y 4E9, Canada

Location

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

Centre hospitalier universitaire de Québec

Québec, Quebec, G1R 2J7, Canada

Location

Related Publications (1)

• 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.

  PMID: 30610026 DERIVED

MeSH Terms

Conditions

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Neoplasms; Hypothermia; Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Ice

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health

Study Officials

• Ilias Cagiannos, MD

  The Ottawa Hospital, Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 9, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 27, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)