Mannitol Use During Partial Nephrectomy Prior to Renal Ischemia and Impact on Renal Function Outcomes
Condition: Renal Cancer
MeSH terms: Kidney Neoplasms; Ischemia
Intervention: mannitol; placebo
Intervention description: After induction of general anesthesia Normosol or Lactated Ringers , at a target infusion rate of 10cc/kg (+/- 1cc/kg), will be administered over the first hour of surgery. After the first hour of surgery IV fluid will be administered at 6cc/kg (+/- 1cc/kg) intended to maintain a minimum systolic blood pressure of 90-100mmHg and a minimum urine output of 0.5cc/kg/hour. The treatment arm will receive a standard dose of 12.5 grams of mannitol (200 cc of a 6.25% mannitol solution) intravenously completely infused through an existing intravenous access catheter within 30 minutes prior to renal artery clamping.; After induction of general anesthesia Normosol or Lactated Ringers at a target infusion rate of 10cc/kg (+/- 1cc/kg), will be administered over the first hour of surgery. After the first hour of surgery IV fluid will be administered at 6cc/kg (+/- 1cc/kg) intended to maintain a minimum systolic blood pressure of 90-100mmHg and a minimum urine output of 0.5cc/kg/hour. The placebo arm will receive 200cc of normal saline completely infused within 30 minutes prior to renal artery clamping.
Intervention MeSH terms: Mannitol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney; MANNITOL; PLACEBO; Partial Nephrectomy; 12-079

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.
    

Eligibility 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.