Mannitol Use During Partial Nephrectomy Prior to Renal Ischemia and Impact on Renal Function Outcomes
Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Cancer
Intervention: mannitol (Drug); placebo (Other)
Phase: Phase 3
Status: Recruiting
Sponsored by: Memorial Sloan Kettering Cancer Center Official(s) and/or principal investigator(s): Jonathan Coleman, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center
Overall contact: Jonathan Coleman, MD, Phone: 646-422-4432
Summary
The purpose of this study is to determine if a medication called mannitol, can help the
kidney maintain its function after kidney surgery. Mannitol is used to cause an increase in
urine production (it is a diuretic). For many years, mannitol has been given to patients in
the hope it would improve the kidney's circulation, and in doing so reduce the impact of the
surgery on the kidney.
Mannitol is given during the surgery before the blood supply to the kidney is stopped. The
blood supply to the kidney is stopped in order to minimize any blood loss during the removal
of the tumor, and also to assist the surgeons view of the kidney anatomy. Once the tumor is
removed the blood supply to the kidney is resumed. Sometimes a side effect of this temporary
reduction in blood supply to the kidney is the loss of some kidney function. This may happen
either in the short term (right away) or long term (months or years later). In studies done
on animals, mannitol was able to lessen this damage to kidney function. However, no human
study has ever confirmed that mannitol has the same helpful effect in humans. There is some
suggestion that it may have no effect. Because sufficient research has yet to be done on
humans, many surgeons do not give mannitol. A recent study, conducted at Memorial Sloan
Kettering which looked back at patients who had undergone partial nephrectomies, an
operation where only the portion of the kidney that contains the tumor is removed and
enables the normal, unaffected portion of the kidney to be preserved. The results of this
study demonstrated no significant difference in kidney function when the investigators
compared patients who were given mannitol to those who were not. The investigators hope that
this study will help clarify the effectiveness or not of mannitol on kidney function. During
the surgery to remove the kidney tumor, patients will receive either mannitol or a placebo.
A placebo, is a harmless medication that has no effects. The impact of mannitol compared to
the placebo will be assessed by routine blood tests and imaging (kidney scan) 6 months after
your surgery.
Clinical Details
Official title: Phase 3 Trial of Intravenous Mannitol Use During Partial Nephrectomy Prior to Renal Ischemia and Impact on Renal Function Outcomes
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: difference in eGFR
Secondary outcome: difference in eGFR
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age > or = to 18 years
- Scheduled for partial nephrectomy at MSKCC (open or minimally invasive technique)
during which renal ischemia is anticipated
- Preoperative eGFR > 45 cc/min/1. 73m2 as measured by the CKD-EPI study equation
Exclusion Criteria:
- Allergy to mannitol
- Severe renal impairment (stage 3B) defined as eGFR < 45 cc/min/1. 73m2 as measured by
the CKD-EPI calculation.
- Combined major surgical cases that include a partial nephrectomy.
Locations and Contacts
Jonathan Coleman, MD, Phone: 646-422-4432
Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States; Recruiting Jonathan Coleman, MD, Phone: 646-422-4432 Karim Touijer, MD, Phone: 646-422-4486 Jonathan Coleman, MD, Principal Investigator
Additional Information
Memorial Sloan Kettering Cancer Center
Starting date: May 2012
Last updated: August 11, 2015
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