Based on animal studies, it was found that administration of endothelial receptor antagonists before and after renal blood vessels clamp and release results in a significantly reduced renal function injury.
On the basis of these results, we chose to divide the study population into 2 groups: control group that would be treated the standard accepted preventive treatment: intravenous injection of Mannitol, cooling of the kidney surface, compared to the treatment group that in addition would receive pre- and post-operative treatment of endothelial receptor antagonists (Ambrisentan (Volibris (10mg).
To be noticed that the drug is recognized and is given as a primary indication for patients with pulmonary hypertension.
The differences between the renal function and biomarkers for pre- and post-operative renal ischemic injury would be examined in order to disclose if the kidney injury of the treated group was indeed smaller.
This information will enable us to protect the operated kidneys from the ischemic damage, especially in those patients with poor basic renal function.
Full Title of Study: “Effects of Endothelin Receptor Antagonist on Ischemic Kidney Injury During Nephron Sparing Surgery for Renal Mass Excision: Assessment by Ischemia Biomarkers, NGAL, KIM-1″
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Sequential Assignment
- Primary Purpose: Prevention
- Masking: None (Open Label)
- Study Primary Completion Date: February 1, 2020
This is a study aimed at examining the protective effect of endothelin antagonism on the ischemic damage the kidney undergoes during partial nephrectomy for kidney lesion removal.
In such procedure, it is common to clamp the kidney blood vessels in order to eliminate blood flow in the surgical field that will enable clear visibility to differentiate the tumor tissue from the normally kidney parenchyma.
Later, after removing the tumor lesion and suturing the tumor bed, the blockage is released and the renal blood flow returns.
The blockage itself and its release causes damage to the kidney tissue that is usually reduced by the kidney's cooling (through ice crystals)and as well as intravenous injection of mannitol.
In this study, patients were divided into 2 groups randomly, assigned the receipt in the order of recruitment.
The first group will receive the standard treatment and the other will be given before and after surgery endothelin antagonists in addition to the standard treatment. The drug will be given once a day for 5 days, starting 48 hours before surgery. Treatment efficacy assessment will be based on comparison of renal function (serum creatinine level and glomerular filtration) as well as biomarkers of acute renal damage (NGAL, KIM-1, and others) that will be taken from patients before and at different time points after surgery: urine samples to be taken at the following time points: – 3 , 8,24,48,72 hours after surgery. Blood samples will be taken at the following time points: – 8, 24, 48, 72 hours after surgery.
- Drug: Ambrisentan 10 MG
- be given once a day for 5 days, starting 48 hours before surgery
Arms, Groups and Cohorts
- Active Comparator: Treated group
- Tab. Volibris 10mg given once a day for 5 days, starting 48 hours before surgery (in addition for the standard treatment for partial nephrectomy)
- No Intervention: Control group
- Treated with the standard treatment for partial nephrectomy
Clinical Trial Outcome Measures
- RENAL FUNCTION INJURY
- Time Frame: 2 YEARS
- quantified by serum CRE, KIM-1,NGAL and urine markers KIM-1 NGAL
Participating in This Clinical Trial
1. Patients with a single kidney lesion who undergo Contrast enhancement (by CT scan)
2. Normal contra-lateral kidney as illustrated by imaging tests
3. Patients eligible for anesthesia and surgery
1. Patients with chronic kidney infections
2. Blood clot disorders
3. End-stage renal failure
4. Patients sensitive to the study drug
5. Patients with cardiac heart failure, EF <40%
6. Patients with hyperkalemia
7. Patients with systolic blood pressure under 90 mmHg
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 99 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Bnai Zion Medical Center
- Rambam Health Care Campus
- Provider of Information About this Clinical Study
- Principal Investigator: Ofir. Avitan, Dr. Avitan Ofir – Bnai Zion Medical Center
- Overall Official(s)
- Ofir Avitan, M.D., Principal Investigator, Bnai-zion medical center, Haifa, Israel
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