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

NCT04450095 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-06-29

No results posted yet for this study

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.

Conditions

  • Kidney Failure, Acute

Interventions

DRUG

Ambrisentan 10 MG

be given once a day for 5 days, starting 48 hours before surgery

Sponsors & Collaborators

  • Rambam Health Care Campus

    collaborator OTHER

  • Bnai Zion Medical Center

    lead OTHER_GOV

Principal Investigators

  • Ofir Avitan, M.D. · Bnai-zion medical center, Haifa, Israel

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-11
Primary Completion
2020-02-01
Completion
2020-10-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04450095 on ClinicalTrials.gov