Effects of Endothelin Receptor Antagonist on Ischemic Kidney Injury During Nephron Sparing Surgery

• Status: Active, not recruiting
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bnai Zion Medical Center
• Collaborator: Rambam Health Care Campus
• Treatments: Ambrisentan

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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